NICEVIVA
MONOGRAPH SPEC LATEST 2026

Inulin (Prebiotic)

PROBIOTICS · Evidence Monograph

Inulin (Prebiotic) is an evidence-graded probiotics monograph evaluated across 30 peer-reviewed PubMed studies (6 meta-analyses, 4 systematic reviews, and 7 randomized controlled trials, encompassing n = 6,909 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for intestinal microbiome diversity, mucosal barrier integrity, and SCFA production.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 30 Studies
Meta-Analyses · Reviews 6 Meta · 4 Systematic Reviews
Randomized Trials (RCT) 7 RCTs (5 Double-Blind)
Cumulative Participants n = 6,909
Reported Trial Dosages 1500 g · 20 g/day · 10 g/day
Trial Duration Range 8 weeks · 2 weeks · 6 weeks
Reading Time ~15 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for intestinal microbiome diversity, mucosal barrier integrity, and SCFA production (supported by 30 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (1500 g · 20 g/day · 10 g/day) over a structured 8 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Strain-Specified, Low-FODMAP Enteric or Spore Capsule
Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Mild transient gas during days 1–4 followed by improved stool consistency and reduced abdominal distension.
Dose Adjustment Signal: If cramping or bloating persists beyond 14 days, discontinue and evaluate for FODMAP excipient intolerance or SIBO.
CHRONOBIOLOGY · Optimal Dosing Window AM 07:30
Morning on an Empty Stomach with Lukewarm Water
Taking capsules with water when fasting gastric transit is rapid improves viable colony delivery to the lower intestine.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
weight (PubMed clinical endpoint)
gut (PubMed clinical endpoint)
diabetes (PubMed clinical endpoint)
01

What Is Inulin (Prebiotic) & Why Does Form Matter?

Inulin (Prebiotic) is classified under PROBIOTICS and has been investigated across 30 peer-reviewed PubMed publications for its role in intestinal microbiome diversity, mucosal barrier integrity, and SCFA production.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (1500 g, 20 g/day, 10 g/day).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Inulin (Prebiotic) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (7 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Inulin (Prebiotic) acts on pathways governing intestinal microbiome diversity, mucosal barrier integrity, and SCFA production. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Inulin (Prebiotic) an overall evidence rating of GRADE High (4.0 / 4.0) based on 30 PubMed studies: 6 meta-analyses, 4 systematic reviews, and 7 randomized controlled trials (5 double-blind, n = 6,909 total participants).

Representative peer-reviewed findings include: • PMID:41059033 (2025) — "Meta-analytical insight on probiotic metabolites and inflammatory markers in diabetes." (SCFA levels rose significantly, with butyrate showing the strongest effect (SMD = +0.46).) • PMID:40331741 (2025) — "Inulin Modulates Gut Microbiota and Increases Short-Chain Fatty Acids Levels to Inhibit Colon Tumorigenesis in Rat Models: A Systematic Review and Meta-Analysis." (Results indicate that inulin supplementation significantly reduced aberrant crypt foci count in rats (SMD = -3.805, 95% CI, -7.348 to -0.262, p < 0.001), increased cecal weight (SMD = 6.723, 95% CI, 3.395-10.051, p = 0.000), enhanced colonic lactobacillus counts (SMD = 1.307, 95%) • PMID:40215676 (2025) — "Effect of prebiotics on growth metrics in infants: A GRADE approach systematic review and meta-analysis of randomized clinical trials." (In conclusion, while prebiotics did not consistently enhance growth metrics, specific combinations showed potential benefits, emphasizing the need for tailored approaches in infant formula design to optimize growth without compromising health.)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)SMD Effect Size & 95% CI DistributionEstimate (95% CI)PMID 41059033-0.54PMID 40331741-3.81 (-7.35–-0.26)PMID 40215676-0.48-8.5Null (0)1.1Metric: SMD
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Strain-Specified, Low-FODMAP Enteric or Spore Capsule. Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 1500 g · 20 g/day · 10 g/day · 7.5 g/day over 8 weeks · 2 weeks · 6 weeks · 32 weeks. Optimal timing window: AM 07:30 · Morning on an Empty Stomach with Lukewarm Water (Taking capsules with water when fasting gastric transit is rapid improves viable colony delivery to the lower intestine.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Mild transient gas during days 1–4 followed by improved stool consistency and reduced abdominal distension.

Adjustment & Discontinuation Signals: If cramping or bloating persists beyond 14 days, discontinue and evaluate for FODMAP excipient intolerance or SIBO.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Inulin (Prebiotic), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (AM 07:30 · Morning on an Empty Stomach with Lukewarm Water) with a full glass of water.
  • Stay within clinically studied daily dosages (1500 g · 20 g/day · 10 g/day) and re-evaluate efficacy after 8 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (30 Studies) · 23 Quantitative Analyses

01
CLINICAL STUDY Frontiers in cellular and infection microbiology (2025) PMID: 41059033 ↗
Meta-analytical insight on probiotic metabolites and inflammatory markers in diabetes.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Frontiers in cellular and infection microbiology (SMD -0.54). Key conclusion: SCFA levels rose significantly, with butyrate showing the strongest effect (SMD = +0.46).
View Original PubMed Abstract ↓

INTRODUCTION: Systemic inflammation is a hallmark of diabetes mellitus and contributes to insulin resistance and disease progression. Emerging evidence suggests that gut microbiota and their metabolites, particularly short-chain fatty acids (SCFAs), play a crucial role in modulating immune responses. Probiotics and synbiotics are increasingly explored for their potential to mitigate inflammation via microbiota-targeted mechanisms. This study aims to evaluate the effects of probiotic and synbiotic supplementation on inflammatory markers and microbial metabolites in individuals with type 1 and type 2 diabetes through meta-analytical techniques. METHODS: A total of 46 randomized controlled trials (RCTs) comprising 3,580 diabetic patients were included following PRISMA guidelines. Meta-analyses were performed using random-effects models to assess changes in inflammatory markers (CRP, IL-6, TNF-α, IL-10) and SCFA levels (butyrate, propionate, acetate). Subgroup analyses and meta-regressions were conducted to identify effect modifiers such as intervention duration, formulation type (probiotic vs. synbiotic), and SCFA concentrations. RESULTS: Probiotic/synbiotic interventions led to significant reductions in CRP (SMD = -0.54), IL-6 (SMD = -0.41), and TNF-α (SMD = -0.48), along with an increase in IL-10 (SMD = +0.38). SCFA levels rose significantly, with butyrate showing the strongest effect (SMD = +0.46). Meta-regression revealed that butyrate levels, synbiotic use, and intervention duration ≥8 weeks were strong predictors of anti-inflammatory efficacy. Multi-strain and synbiotic interventions were more effective than single-strain or probiotic-only formulations. Sensitivity analyses confirmed the robustness of findings, and publication bias was minimal. DISCUSSION: These findings support the adjunctive use of targeted, SCFA-oriented probiotic formulations (e.g., Lactobacillus plantarum, Lactobacillus casei, Bifidobacterium longum with inulin/FOS, ≥10^9-10^10 CFU/day) to mitigate metabolic inflammation alongside standard care. Strain- and dose-standardized RCTs should confirm impacts on glycemic and cardiometabolic outcomes.

02
META-ANALYSIS Journal of food science (2025) PMID: 40331741 ↗
Inulin Modulates Gut Microbiota and Increases Short-Chain Fatty Acids Levels to Inhibit Colon Tumorigenesis in Rat Models: A Systematic Review and Meta-Analysis.
Clinical Trial Synthesis 2025 Meta-Analysis published in Journal of food science; statistical significance reported at p = 0.001 (SMD -3.805). Key conclusion: Results indicate that inulin supplementation significantly reduced aberrant crypt foci count in rats (SMD = -3.805, 95% CI, -7.348 to -0.262, p < 0.001), increased cecal weight (SMD = 6.723, 95% CI, 3.395-10.051, p = 0.000), enhanced colonic lactobacillus counts (SMD = 1.307, 95%
View Original PubMed Abstract ↓

Colorectal cancer (CRC) incidence rises with age, driven by factors such as diet. Inulin, a soluble fiber found in plants like Jerusalem artichoke and chicory, may influence CRC risk by modulating gut microbiota and improving metabolic profiles. This systematic review and meta-analysis evaluate the effects of inulin on CRC in animal models and explore its underlying mechanisms. A comprehensive search of nine databases led to the selection of 12 studies from an initial pool of 114 articles, based on predefined inclusion criteria. Standardized meta-analyses were performed for eligible studies. Results indicate that inulin supplementation significantly reduced aberrant crypt foci count in rats (SMD = -3.805, 95% CI, -7.348 to -0.262, p < 0.001), increased cecal weight (SMD = 6.723, 95% CI, 3.395-10.051, p = 0.000), enhanced colonic lactobacillus counts (SMD = 1.307, 95% CI, 0.644-1.970, p = 0.000), decreased coliform bacteria (SMD = -1.659, 95% CI, -2.147 to -1.171, p = 0.000), and elevated colonic short-chain fatty acids (SCFAs) levels, including acetate (SMD = 3.50, 95% CI, 1.111-5.890, p < 0.001), propionate (SMD = 3.081, 95% CI, 1.416-4.746, p < 0.001), and butyrate (SMD = 4.471, 95% CI, 2.464-6.478, p < 0.001). This systematic review demonstrates inulin's chemopreventive effects against CRC in animal models by enhancing beneficial gut bacteria (e.g., lactobacillus) and boosting SCFAs. Findings advocate integrating inulin-rich foods/supplements into prevention strategies for precision prebiotic development via SCFA-mediated epigenetic and antitumor mechanisms. © 2025 Institute of Food Technologists.

03
META-ANALYSIS Nutrition research (New York, N.Y.) (2025) PMID: 40215676 ↗
Effect of prebiotics on growth metrics in infants: A GRADE approach systematic review and meta-analysis of randomized clinical trials.
Clinical Trial Synthesis 2025 Meta-Analysis published in Nutrition research (New York, N.Y.); statistical significance reported at p = 0.05 (SMD -0.479). Key conclusion: In conclusion, while prebiotics did not consistently enhance growth metrics, specific combinations showed potential benefits, emphasizing the need for tailored approaches in infant formula design to optimize growth without compromising health.
View Original PubMed Abstract ↓

Breastfeeding is often not feasible for all mothers, making infant formula a critical alternative for ensuring infant safety and nutrition. We hypothesized that the inclusion of prebiotics in infant formula significantly affects growth metrics in infants compared to standard formula. This study aims to fill a knowledge gap regarding the effects of prebiotics in infant formula on infant growth and development, particularly given the varying compositions and durations of prebiotic supplementation. A systematic review was conducted following PRISMA guidelines, analyzing 24 studies sourced from databases such as PubMed and Cochrane, with risk of bias assessed using RoB-2 for randomized controlled trials (RCTs). The findings revealed no significant differences in weight gain (WG), height gain (HG), or head circumference gain (HCG) between prebiotic-fed infants and control groups overall. However, infants receiving prebiotics for 3 or more months exhibited a significant decrease in WG compared to controls (SMD -0.479, P < .05). Notably, those fed formulas containing fructo-oligosaccharides/galacto-oligosaccharides and a combination of polydextrose/galacto-oligosaccharides/lactulose demonstrated improved WG (SMDs of 0.214 and 0.184, P < .05 respectively). Conversely, infants on formulas with inulin-enriched oligo-fructose (IOF) experienced reduced WG and HG. In conclusion, while prebiotics did not consistently enhance growth metrics, specific combinations showed potential benefits, emphasizing the need for tailored approaches in infant formula design to optimize growth without compromising health.

04
META-ANALYSIS Journal of gastroenterology and hepatology (2025) PMID: 39482823 ↗
Gut microbiome-targeted therapies as adjuvant treatments in inflammatory bowel diseases: a systematic review and network meta-analysis.
Clinical Trial Synthesis 2025 Meta-Analysis published in Journal of gastroenterology and hepatology. Key conclusion: CONCLUSIONS: FMT and multistrain probiotics showed superior efficacy in UC.
View Original PubMed Abstract ↓

BACKGROUND AND AIM: Gut microbiome-targeted therapies (MTTs), including prebiotics, probiotics, synbiotics, and fecal microbiota transplantation (FMT), have been widely used in inflammatory bowel diseases (IBD), but the best MTTs has not yet been confirmed. We performed a network meta-analysis (NMA) to examine this in ulcerative colitis (UC) and Crohn's disease (CD). METHODS: We searched for randomized controlled trials (RCTs) on the efficacy and safety of MTTs as adjuvant therapies for IBD until December 10, 2023. Data were pooled using a random effects model, with efficacy reported as pooled relative risks with 95% CIs, and interventions ranked according to means of surfaces under cumulative ranking values. RESULTS: Thirty-eight RCTs met the inclusion criteria. Firstly, we compared the efficacy of MTTs in IBD patients. Only FMT and probiotics were superior to placebo in all outcomes, but FMT ranked best in improving clinical response rate and clinical and endoscopic remission rate, and probiotics ranked second in reducing clinical relapse rate showed significant efficacy, while prebiotics ranked first showed nonsignificant efficacy. Subsequently, we conducted NMA for specific MTT formulations in UC and CD separately, which revealed that FMT, especially combined FMT via colonoscopy and enema, showed significant efficacy and was superior in improving clinical response and remission rate of active UC patients. As for endoscopic remission and clinical relapse, multistrain probiotics based on specific genera of Lactobacillus and Bifidobacterium showed significant efficacy and ranked best in UC. In CD, we found that no MTTs were significantly better than placebo, but synbiotics comprising Bifidobacterium and fructo-oligosaccharide/inulin mix and Saccharomyces ranked best in improving clinical remission and reducing clinical relapse, respectively. Moreover, FMT was safe in both UC and CD. CONCLUSIONS: FMT and multistrain probiotics showed superior efficacy in UC. However, the efficacy of MTTs varies among different IBD subtypes and disease stages; thus, the personalized treatment strategies of MTTs are necessary. © 2024 Journal of Gastroenterology and Hepatology Fou

05
META-ANALYSIS The American journal of clinical nutrition (2024) PMID: 39313030 ↗
The effects of chicory inulin-type fructans supplementation on weight management outcomes: systematic review, meta-analysis, and meta-regression of randomized controlled trials.
Clinical Trial Synthesis 2024 Meta-Analysis published in The American journal of clinical nutrition involving n = 1,184 participants (MD -0.39). Key conclusion: CONCLUSIONS: Chicory ITF supplementation may benefit weight management by reducing body weight, BMI, fat mass, waist circumference, and, to a certain extent, body fat percentage.
View Original PubMed Abstract ↓

BACKGROUND: Excess body weight and adiposity can adversely affect metabolic health. Prebiotics such as inulin-type fructans (ITFs) from chicory root are known to modulate gut microbiota and may improve body weight regulation. OBJECTIVES: This study aimed to assess evidence for chicory ITF supplementation to support weight management. METHODS: Eligible articles (initial search to 2021, updated to February 2023) were searched from EMBASE, MEDLINE (PubMed), and Cochrane Library. Data on primary (body weight) and secondary outcomes [body mass index (BMI), total fat mass, body fat percentage, and waist circumference] were extracted by 2 reviewers independently. Random-effects model using inverse-variance method was used. Subgroup analysis (health status and ITF type) and meta-regression (dose and duration) were evaluated. RESULTS: A total of 32 eligible studies were included. Chicory ITF significantly reduced body weight [mean difference (MD): -0.97 kg; 95% CI: -1.34, -0.59); n = 1184] compared with placebo. ITF favored overall effects reduction in BMI (MD: -0.39 kg/m2; 95% CI: -0.57, -0.20; n = 985), fat mass (MD: -0.37 kg; 95% CI: -0.61, -0.13; n = 397), waist circumference (MD: -1.03 cm; 95% CI: -1.69, -0.37; n = 604), and for intervention duration of >8 wk, body fat percentage (MD: -0.78%; 95% CI: -1.17, -0.39; n = 488). Except for considerable heterogeneity in body weight (I2: 73%) and body fat percentage (I2: 75%), all other outcomes had negligible to moderate heterogeneity. Significant reduction in body weight, BMI, and waist circumference was evident irrespective of participants' health status. There was minimal evidence that dose, duration, or type of ITF influenced the magnitude of reductions in outcomes. CONCLUSIONS: Chicory ITF supplementation may benefit weight management by reducing body weight, BMI, fat mass, waist circumference, and, to a certain extent, body fat percentage. This systematic review with meta-analysis was registered at PROSPERO as CRD42020184908.

06
META-ANALYSIS Inflammatory bowel diseases (2025) PMID: 38781004 ↗
Prebiotics for Induction and Maintenance of Remission in Inflammatory Bowel Disease: Systematic Review and Meta-Analysis.
Clinical Trial Synthesis 2025 Meta-Analysis published in Inflammatory bowel diseases involving n = 40 participants (RR 2.75). Key conclusion: CONCLUSION: Prebiotics, particularly FOS and germinated barley foodstuff, show potential as effective and safe dietary supplements for induction and maintenance of remission in UC, respectively.
View Original PubMed Abstract ↓

BACKGROUND: Prebiotics are nondigestible carbohydrates fermented by gut bacteria into metabolites that confer health benefits. However, evidence on their role for inflammatory bowel disease (IBD) is unclear. This study systematically evaluated the research on prebiotics for treatment of IBD. METHODS: A search was performed in PubMed, Embase, Cochrane, and Web of Science. Eligible articles included randomized controlled trials or prospective observational studies that compared a prebiotic with a placebo or lower-dose control in patients with IBD. Meta-analyses were performed using random-effects models for the outcomes of clinical remission, clinical relapse, and adverse events. RESULTS: Seventeen studies were included. For induction of clinical remission in ulcerative colitis (UC), the fructooligosaccharide (FOS) kestose was effective (relative risk, 2.75, 95% confidence interval, 1.05-7.20; n = 40), but oligofructose-enriched inulin (OF-IN) and lactulose were not. For maintenance of remission in UC, germinated barley foodstuff trended toward preventing clinical relapse (relative risk, 0.40; 95% confidence interval, 0.15-1.03; n = 59), but OF-IN, oat bran, and Plantago ovata did not. For Crohn's disease, OF-IN and lactulose were no different than controls for induction of remission, and FOS was no different than controls for maintenance of remission. Flatulence and bloating were more common with OF-IN; reported adverse events were otherwise similar to controls for other prebiotics. CONCLUSION: Prebiotics, particularly FOS and germinated barley foodstuff, show potential as effective and safe dietary supplements for induction and maintenance of remission in UC, respectively. The overall certainty of evidence was very low. There would be benefit in further investigation on the role of prebiotics as treatment adjuncts for IBD. Plain Language Summary: Prebiotics are nutrients fermented by gut microbes into healthful metabolites. This systematic review and meta-analysis examined the available research on the efficacy and safety of prebiotics for the treatment of inflammatory bowel diseases. © The Author(s) 2024. Published by Oxford University Press on behalf of Croh

07
CLINICAL STUDY Food & function (2024) PMID: 38590256 ↗
Effect of inulin, galacto-oligosaccharides, and polyphenols on the gut microbiota, with a focus on Akkermansia muciniphila.
Clinical Trial Synthesis 2024 Meta-Analysis published in Food & function involving n = 451 participants. Key conclusion: In conclusion, our findings suggest that GOS may promote the growth of A.
View Original PubMed Abstract ↓

Inulins, galacto-oligosaccharides (GOS) and polyphenols are considered to stimulate the growth of Akkermansia muciniphila (A. muciniphila) in the gut. We performed a meta-analysis of six microbiome studies (821 stool samples from 451 participants) to assess the effects of inulin, GOS, and polyphenols on the abundance of A. muciniphila in the gut. The intervention of GOS increased the relative abundance of A. muciniphila in healthy participants. Additionally, metabolic pathways associated with carbohydrate metabolism and short-chain fatty acid release were enriched following the GOS intervention. Furthermore, after the GOS intervention, the coexisting microbial communities of A. muciniphila, such as Eubacterium hallii and Bacteroides, exhibited an enhanced correlation with A. muciniphila. In conclusion, our findings suggest that GOS may promote the growth of A. muciniphila in the gut by modulating the gut microbiota composition.

08
META-ANALYSIS The American journal of clinical nutrition (2024) PMID: 38309832 ↗
The effects of inulin-type fructans on cardiovascular disease risk factors: systematic review and meta-analysis of randomized controlled trials.
Clinical Trial Synthesis 2024 Meta-Analysis published in The American journal of clinical nutrition involving n = 2,518 participants (MD -0.06). Key conclusion: CONCLUSION: ITF may reduce low-density lipoprotein, triglycerides, and body weight.
View Original PubMed Abstract ↓

BACKGROUND: Inulin-type fructans (ITF) are the leading prebiotics in the market. Available evidence provides conflicting results regarding the beneficial effects of ITF on cardiovascular disease risk factors. OBJECTIVES: This study aimed to evaluate the effects of ITF supplementation on cardiovascular disease risk factors in adults. METHODS: We searched MEDLINE, EMBASE, Emcare, AMED, CINAHL, and the Cochrane Library databases from inception through May 15, 2022. Eligible randomized controlled trials (RCTs) administered ITF or placebo (for example, control, foods, diets) to adults for ≥2 weeks and reported one or more of the following: low, very-low, or high-density lipoprotein cholesterol (LDL-C, VLDL-C, HDL-C); total cholesterol; apolipoprotein A1 or B; triglycerides; fasting blood glucose; body mass index; body weight; waist circumference; waist-to-hip ratio; systolic or diastolic blood pressure; or hemoglobin A1c. Two reviewers independently and in duplicate screened studies, extracted data, and assessed risk of bias. We pooled data using random-effects model, and assessed the certainty of evidence (CoE) using the Grading of Recommendations, Assessment, Development and Evaluation approach. RESULTS: We identified 1767 studies and included 55 RCTs with 2518 participants in meta-analyses. The pooled estimate showed that ITF supplementation reduced LDL-C [mean difference (MD) -0.14 mmol/L, 95% confidence interval (95% CI: -0.24, -0.05), 38 RCTs, 1879 participants, very low CoE], triglycerides (MD -0.06 mmol/L, 95% CI: -0.12, -0.01, 40 RCTs, 1732 participants, low CoE), and body weight (MD -0.97 kg, 95% CI: -1.28, -0.66, 36 RCTs, 1672 participants, low CoE) but little to no significant effect on other cardiovascular disease risk factors. The effects were larger when study duration was ≥6 weeks and in pre-obese and obese participants. CONCLUSION: ITF may reduce low-density lipoprotein, triglycerides, and body weight. However, due to low to very low CoE, further well-designed and executed trials are needed to confirm these effects. PROSPERO REGISTRATION NUMBER: CRD42019136745.

09
CLINICAL STUDY The Cochrane database of systematic reviews (2023) PMID: 37262358 ↗
Prebiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 705 participants. Key conclusion: BACKGROUND: Dietary supplementation with prebiotic oligosaccharides to modulate the intestinal microbiome has been proposed as a strategy to reduce the risk of necrotising enterocolitis (NEC) and associated mortality and morbidity in very preterm or very low birth weight (VLBW) i
View Original PubMed Abstract ↓

BACKGROUND: Dietary supplementation with prebiotic oligosaccharides to modulate the intestinal microbiome has been proposed as a strategy to reduce the risk of necrotising enterocolitis (NEC) and associated mortality and morbidity in very preterm or very low birth weight (VLBW) infants. OBJECTIVES: To assess the benefits and harms of enteral supplementation with prebiotics (versus placebo or no treatment) for preventing NEC and associated morbidity and mortality in very preterm or VLBW infants. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Maternity and Infant Care database and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), from the earliest records to July 2022. We searched clinical trials databases and conference proceedings, and examined the reference lists of retrieved articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs comparing prebiotics with placebo or no prebiotics in very preterm (< 32 weeks' gestation) or VLBW (< 1500 g) infants. The primary outcomes were NEC and all-cause mortality, and the secondary outcomes were late-onset invasive infection, duration of hospitalisation since birth, and neurodevelopmental impairment. DATA COLLECTION AND ANALYSIS: Two review authors separately evaluated risk of bias of the trials, extracted data, and synthesised effect estimates using risk ratio (RR), risk difference (RD), and mean difference (MD), with associated 95% confidence intervals (CIs). The primary outcomes of interest were NEC and all-cause mortality; our secondary outcome measures were late-onset (> 48 hours after birth) invasive infection, duration of hospitalisation, and neurodevelopmental impairment. We used the GRADE approach to assess the level of certainty of the evidence. MAIN RESULTS: We included seven trials in which a total of 705 infants participated. All the trials were small (mean sample size 100). Lack of clarity on methods to conceal allocation and mask caregivers or investigators were potential sources of bias in three of the trials. The studied prebiotics were fructo- and galacto-oligosaccharides, inulin, and l

10
CLINICAL STUDY The Cochrane database of systematic reviews (2023) PMID: 36799531 ↗
Probiotics for management of functional abdominal pain disorders in children.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 1,309 participants. Key conclusion: MAIN RESULTS: We included 18 RCTs assessing the effectiveness of probiotics and synbiotics in reducing the severity and frequency of pain, involving a total of 1309 patients.
View Original PubMed Abstract ↓

BACKGROUND: Functional abdominal pain is pain occurring in the abdomen that cannot be fully explained by another medical condition and is common in children. It has been hypothesised that the use of micro-organisms, such as probiotics and synbiotics (a mixture of probiotics and prebiotics), might change the composition of bacterial colonies in the bowel and reduce inflammation, as well as promote normal gut physiology and reduce functional symptoms. OBJECTIVES: To assess the efficacy and safety of probiotics in the treatment of functional abdominal pain disorders in children. SEARCH METHODS: We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL) and two clinical trials registers from inception to October 2021. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compare probiotic preparations (including synbiotics) to placebo, no treatment or any other interventional preparation in patients aged between 4 and 18 years of age with a diagnosis of functional abdominal pain disorder according to the Rome II, Rome III or Rome IV criteria. DATA COLLECTION AND ANALYSIS: The primary outcomes were treatment success as defined by the primary studies, complete resolution of pain, improvement in the severity of pain and improvement in the frequency of pain. Secondary outcomes included serious adverse events, withdrawal due to adverse events, adverse events, school performance or change in school performance or attendance, social and psychological functioning or change in social and psychological functioning, and quality of life or change in quality life measured using any validated scoring tool. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). For continuous outcomes, we calculated the mean difference (MD) and corresponding 95% CI. MAIN RESULTS: We included 18 RCTs assessing the effectiveness of probiotics and synbiotics in reducing the severity and frequency of pain, involving a total of 1309 patients. Probiotics may achieve more treatment success when compared with placebo at the end of the treatment, with 50% success in the probiotic group versus 33% success in the p

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