Inulin for Irritable Bowel Syndrome

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Must not be taking: Opioids, Inflammatory drugs, Antidepressants, Ozempic

Disqualifiers: Inflammatory bowel disease, Celiac, Abdominal cancer, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS). The central hypothesis of this study is that specific shifts in the GI microbiome composition correlate with altered colonic SCFAs and BAs and contribute to IBS symptoms. Primary aims include: (a) identifying GI microbiome signatures in IBS subtypes (IBS-C and IBS-D) and matched controls, and test if microbiome signatures in these groups correlate with fecal SCFAs and bacterial fermentation of an indigestible carbohydrate (inulin) after a dietary challenge (fecal inulin), and (b) determining if GI microbiome signatures in IBS subtypes and controls correlate with fecal BAs or markers of SCFA production (fecal SCFAs or inulin) and test if BAs correlate with fecal SCFAs or inulin. The target population is adults ages 18-65 years meeting Rome IV criteria for IBS (both diarrhea- and constipation-predominant, IBS-D and IBS-C) and asymptomatic controls. Primary outcomes will be fecal bile acid excretion and profile, short-chain fatty acid excretion and profile, colonic transit, and fecal microbiota. Secondary outcomes will be stool characteristics based on responses to validated bowel diaries. Stool samples will be collected from participants during the last 2 days of a 4-day 100 g fat diet and split into 3 samples for fecal microbiota, SCFA, and bile acid analysis.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that affect gastrointestinal function, like opioids, inflammatory drugs, or certain antidepressants, within 2 days before the study if you have IBS. However, stable low doses of antidepressants taken for more than a month may be allowed. Rescue medication for constipation is permitted if needed.

What data supports the effectiveness of the treatment Inulin, Fructo-oligosaccharides, Prebiotic fiber for Irritable Bowel Syndrome?

Research shows that inulin can help regulate bowel movements and improve stool consistency in people with IBS with constipation (IBS-C), while agave fructans, a type of prebiotic fiber, significantly increased bowel movements and improved quality of life in IBS-C patients.

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Is inulin safe for humans?

Inulin-type fructans, like those derived from chicory, are generally safe and can increase beneficial gut bacteria in people of all ages. They may improve bowel function in healthy individuals, but their effects can vary depending on the source and structure of the fructans.

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How does the treatment Inulin differ from other treatments for IBS?

Inulin is a prebiotic fiber that helps regulate bowel movements and improve gut health by changing the composition of gut bacteria, making it particularly beneficial for those with IBS-C (constipation subtype). Unlike some other treatments, it focuses on promoting healthy gut microbiota rather than just alleviating symptoms.

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Eligibility Criteria

Adults aged 18-65 with IBS, meeting Rome IV criteria for the condition, can join this study. It's also open to people without symptoms as control volunteers. Participants should be able to follow a specific diet and provide stool samples.

Inclusion Criteria

I am between 18 and 75 years old.

I am healthy with no history of stomach or intestine diseases.

I have been diagnosed with irritable bowel syndrome (IBS).

Exclusion Criteria

I haven't taken medications that affect my stomach or study results in the last 6 months.

I can use specific medication for severe constipation if necessary.

I have not taken prebiotics or probiotics in the last 2 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Dietary Challenge

Participants follow a low fiber, high fat diet and record stool symptoms and patterns

4 days

At-home

Inulin Challenge

Participants ingest inulin and provide stool samples for analysis

2 days

2 visits (in-person)

Follow-up

Participants are monitored for dietary recall and stool characteristics

4 days

At-home

Optional Dietary Follow-up

Participants complete an optional dietary assessment using the ASA24 tool

60 days

Participant Groups

The trial is testing how a dietary challenge with inulin affects gut bacteria and substances like bile acids and short-chain fatty acids in those with IBS compared to healthy controls.

Group I: Irritable Bowel Syndrome Patients with Diarrhea (IBS-D) Experimental Treatment 1 Intervention

Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS.

Group II: Irritable Bowel Syndrome Patients with Constipation (IBS-C) Experimental Treatment 1 Intervention

Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS.

Group III: Healthy volunteers Experimental Treatment 1 Intervention

Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.

Inulin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Inulin for:

• Dietary supplement
• Prebiotic

🇺🇸 Approved in United States as Inulin for:

• Dietary supplement
• Prebiotic

🇨🇦 Approved in Canada as Inulin for:

• Dietary supplement
• Prebiotic

🇯🇵 Approved in Japan as Inulin for:

• Dietary supplement
• Prebiotic

🇨🇳 Approved in China as Inulin for:

• Dietary supplement
• Prebiotic

🇨🇭 Approved in Switzerland as Inulin for:

• Dietary supplement
• Prebiotic

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, Los Angeles Los Angeles, CA

Who Is Running the Clinical Trial?

University of California, Los Angeles Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of varying dietary content of fermentable short-chain carbohydrates on symptoms, fecal microenvironment, and cytokine profiles in patients with irritable bowel syndrome. [2022] A diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) is increasingly recommended for patients with irritable bowel syndrome (IBS). We aimed to investigate the effects of a blinded low-FODMAP vs high-fructo-oligosaccharides (FOS) diet on symptoms, immune activation, gut microbiota composition, and short-chain fatty acids (SCFAs).

2. Greece pubmed.ncbi.nlm.nih.gov

Effect of inulin in the treatment of irritable bowel syndrome with constipation (Review). [2020] At present, irritable bowel syndrome (IBS) is a common medical problem all over the world that implies considerable social burden and high costs. Considering the different pathophysiological pathways, unitary management for IBS is not possible. Of the therapeutic approaches that have been proposed so far, only a few have been demonstrated to have beneficial effects in IBS patients. The implication of gut microbiota in IBS is obvious, similarly to the therapeutic effect of pro-/prebiotics, which is reflected by the latest publications. The intake of inulin seems to regulate the bowel peristalsis and colonic transit, the consistency and frequency of the stools, as it changes the composition of gut microbiota. The beneficial effect of inulin in patients with IBS-constipation form (IBS-C) is obvious, but still, more randomized controlled clinical trials involving large samples of patients are needed in order to provide more evidence.

3. United States pubmed.ncbi.nlm.nih.gov

Fructo-oligosaccharide intensifies visceral hypersensitivity and intestinal inflammation in a stress-induced irritable bowel syndrome mouse model. [2018] To determine whether fructo-oligosaccharide (FOS) affects visceral sensitivity, inflammation, and production of intestinal short-chain fatty acids (SCFA) in an irritable bowel syndrome (IBS) mouse model.

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Agave Fructans in a Functional Food Consumed by Patients with Irritable Bowel Syndrome with Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial. [2023] Irritable bowel syndrome displays three different subtypes: constipation (IBS-C), diarrhea (IBS-D), and mixed (IBS-M). Treatment with dietary fiber is used, with consideration given both to the chemical composition of the fiber and to the different subtypes of IBS. The IBS-D subtype is usually treated with a low-FODMAPs diet, whereas the IBS-C subtype suggests prebiotics and probiotics to promote microbiota restoration. The aim of this study was to assess the effects of employing agave fructans as the soluble fiber of a jelly (Gelyfun®gastro) containing 8 g per serving in the IBS-C group (n = 50), using a randomized, double-blind, time-limited trial for four weeks. We evaluated changes in the frequency and types of bowel movements through the Bristol scale, and the improvement of the condition was evaluated using quality of life (IBS-QOL) and anxiety-depression (HADS) scales. The main results were that the number of bowel movements increased by more than 80%, with at least one stool per day from fifteen days onwards, without a laxative effect for the group treated. Finally, the quality of life with the prebiotic jelly was significantly improved compared to the placebo in all specific domains, in addition to significantly reducing anxiety and depression.

5. United States pubmed.ncbi.nlm.nih.gov

Ehealth: low FODMAP diet vs Lactobacillus rhamnosus GG in irritable bowel syndrome. [2022] To investigate the effects of a low fermentable, oligosaccharides, disaccharides, monosaccharides and polyols diet (LFD) and the probiotic Lactobacillus rhamnosus GG (LGG) in irritable bowel syndrome (IBS).

6. United States pubmed.ncbi.nlm.nih.gov

Effect of chicory-derived inulin-type fructans on abundance of Bifidobacterium and on bowel function: a systematic review with meta-analyses. [2022] Inulin-type fructans are considered to stimulate the growth of beneficial microorganisms, like Bifidobacterium in the gut and support health. However, both the fructan source and chemical structure may modify these effects. A systematic review was conducted to assess the effects of chicory-derived inulin-type fructans consumed either in specific foods or as dietary supplements on abundance of Bifidobacterium in the gut and on health-related outcomes. Three electronic databases and two clinical trial registries were systematically searched until January 2021. Two authors independently selected randomized controlled trials that investigated with a protocol of minimum seven days supplementation the effect of chicory-derived inulin-type fructans on Bifidobacterium abundance in any population. Meta-analyses with random-effects model were conducted on Bifidobacterium abundance and bowel function parameters. We evaluated risk of bias using Cochrane RoB tool. Chicory-derived inulin-type fructans at a dose of 3-20 g/day significantly increased Bifidobacterium abundance in participants with an age range from 0 to 83 years (standardized mean difference: 0.83, 95% CI: 0.58-1.08; p < 0.01; 50 studies; 2525 participants). Significant bifidogenic effects were observed in healthy individuals and in populations with health impairments, except gastrointestinal disorders. Significant beneficial effects on bowel function parameters were observed in healthy subjects. Chicory-derived inulin-type fructans may have significant bifidogenic effects and may beneficially influence bowel function in healthy individuals. PROSPERO registration number CRD42020162892.

7. England pubmed.ncbi.nlm.nih.gov

Review article: biological mechanisms for symptom causation by individual FODMAP subgroups - the case for a more personalised approach to dietary restriction. [2020] Due to the paucity of targeted therapy for irritable bowel syndrome (IBS), many patients turn to dietary modifications for symptom management. The combination of five subgroups of poorly absorbed and rapidly fermented carbohydrates-fructans, galacto-oligosaccharides, lactose, excess fructose and polyols-are thought to trigger gastrointestinal symptoms and are referred to collectively as "FODMAPs".

8. England pubmed.ncbi.nlm.nih.gov

Dietary intake of inulin-type fructans in active and inactive Crohn's disease and healthy controls: a case-control study. [2016] Prebiotic inulin-type fructans are widely consumed in the diet and may have contrasting effects in Crohn's disease by stimulating gut microbiota and/or by generating functional gastrointestinal symptoms. The aim of this study was to measure fructan and oligofructose intakes in patients with active and inactive Crohn's disease compared with healthy controls.

9. Switzerland pubmed.ncbi.nlm.nih.gov

Inulin, Choline and Silymarin in the Treatment of Irritable Bowel Syndrome with Constipation-Randomized Case-Control Study. [2023] (1) Background: Irritable bowel syndrome (IBS) is a common disease, with multiple pathophysiological mechanisms involved. A single treatment for all the patients with IBS is not possible. Prebiotics may have a beneficial effect on IBS patients with constipation. (2) Methods: A randomized cross-over case-control study was conducted, including patients with IBS and constipation (IBS-C), who were randomized into two groups receiving a specific constipation diet with or without a food supplement containing inulin, choline and silymarin (Stoptoxin®, Fiterman Pharma, Iasi, Romania). Patients were evaluated at baseline, after four and eight weeks, using a questionnaire to assess IBS symptoms. (3) Results: 51 IBS-C patients were included, of which 47 patients finished the trial (33 women, mean age 52.82 years). Adding Stoptoxin® to a diet for constipation brought extra benefits. Abdominal pain severity improved by 68.3% after the diet and Stoptoxin® (p = 0.004) and abdominal bloating severity parameter improved by 34.8% (p = 0.040). The stool number per week and the stool consistency according to the Bristol scale were improved, but without statistical significance between groups (p > 0.05). (4) Conclusions: The combination of inulin, choline and silymarin associated with a specific-constipation diet had obvious clinical beneficial effects on IBS-C patients in terms of bowel movement, abdominal pain and bloating.

10. Turkey pubmed.ncbi.nlm.nih.gov

Efficacy of synbiotic, probiotic, and prebiotic treatments for irritable bowel syndrome in children: A randomized controlled trial. [2022] Irritable bowel syndrome (IBS) is an important health problem that presents serious social burdens and high costs. Our study investigated the efficacy of synbiotic (Bifidobacterium lactis B94 with inulin), probiotic (B. lactis B94), and prebiotic (inulin) treatment for IBS in a pediatric age group.