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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{2 4 8 9 10}

Research Team

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

Treatment Details

Interventions

• Inulin (Dietary Supplement)

Trial Overview 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.

Participant Groups

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

Trials

1594

Patients Recruited

10,430,000+

Findings from Research

NCBI (Pubmed)

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. Hustoft, TN., Hausken, T., Ystad, SO., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of inulin in the treatment of irritable bowel syndrome with constipation (Review). Bărboi, OB., Ciortescu, I., Chirilă, I., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fructo-oligosaccharide intensifies visceral hypersensitivity and intestinal inflammation in a stress-induced irritable bowel syndrome mouse model. Chen, BR., Du, LJ., He, HQ., et al.[2018]

NCBI (Pubmed)

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. Camacho-Díaz, BH., Arenas-Ocampo, ML., Osorio-Díaz, P., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ehealth: low FODMAP diet vs Lactobacillus rhamnosus GG in irritable bowel syndrome. Pedersen, N., Andersen, NN., Végh, Z., et al.[2022]

NCBI (Pubmed)

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. Nagy, DU., Sándor-Bajusz, KA., Bódy, B., et al.[2022]

NCBI (Pubmed)

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. Wang, XJ., Camilleri, M., Vanner, S., et al.[2020]

NCBI (Pubmed)

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. Anderson, JL., Hedin, CR., Benjamin, JL., et al.[2016]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inulin, Choline and Silymarin in the Treatment of Irritable Bowel Syndrome with Constipation-Randomized Case-Control Study. Bărboi, OB., Chirilă, I., Ciortescu, I., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of synbiotic, probiotic, and prebiotic treatments for irritable bowel syndrome in children: A randomized controlled trial. Baştürk, A., Artan, R., Yılmaz, A.[2022]

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]

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

Effect of inulin in the treatment of irritable bowel syndrome with constipation (Review). [2020]

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]

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]

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

Ehealth: low FODMAP diet vs Lactobacillus rhamnosus GG in irritable bowel syndrome. [2022]

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]

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]

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]

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]

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]