Inulin for Irritable Bowel Syndrome

Age: Any Age

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

72 Participants Needed

Trial Summary

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}

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.

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 healthy with no history of stomach or intestine diseases.

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

No dietary restrictions other than vegetarian

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.

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

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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

A low-FODMAP diet significantly improved IBS symptoms in patients, with 80% reporting relief after 3 weeks, compared to only 30% with FOS supplementation.

The low-FODMAP diet led to decreased levels of proinflammatory cytokines and changes in gut microbiota composition, suggesting it may positively impact gut health beyond just symptom relief.

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]

Inulin, a type of prebiotic, has shown promise in improving symptoms of irritable bowel syndrome (IBS), particularly in patients with the constipation form (IBS-C), by regulating bowel movements and altering gut microbiota composition.

Despite the positive effects of inulin, more large-scale randomized controlled trials are necessary to strengthen the evidence for its efficacy in treating IBS.

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]

In a study involving mice with an irritable bowel syndrome (IBS) model, fructo-oligosaccharide (FOS) administration increased visceral hypersensitivity and gut inflammation specifically in mice subjected to stress, indicating a potential negative effect in this context.

FOS also led to higher production of short-chain fatty acids (SCFAs) like acetic, propionic, and butyric acids, suggesting that while it may enhance SCFA levels, it could exacerbate IBS symptoms under stress conditions.

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]

In a study involving 50 participants with constipation-predominant irritable bowel syndrome (IBS-C), treatment with agave fructans in a jelly significantly increased the frequency of bowel movements by over 80% within 15 days, without causing a laxative effect.

The prebiotic jelly not only improved bowel movement frequency but also significantly enhanced quality of life and reduced anxiety and depression symptoms compared to a placebo, indicating its potential as an effective treatment for IBS-C.

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]

A low fermentable diet (LFD) significantly reduced IBS severity scores compared to a normal diet, indicating its effectiveness in managing symptoms of irritable bowel syndrome (IBS) in a study of 123 patients over 6 weeks.

The probiotic Lactobacillus rhamnosus GG (LGG) also showed some efficacy, but did not significantly improve IBS severity compared to the normal diet, suggesting that while both interventions are beneficial, the LFD may be more effective for symptom relief.

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]

Chicory-derived inulin-type fructans, consumed at doses of 3-20 g/day, significantly increase the abundance of beneficial gut bacteria, specifically Bifidobacterium, in a diverse population of 2525 participants across 50 studies.

These fructans not only promote gut health by enhancing Bifidobacterium levels but also improve bowel function in healthy individuals, although their effects were less pronounced in those with gastrointestinal disorders.

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]

Certain FODMAP subgroups, particularly lactose, fructans, and galacto-oligosaccharides, have strong biological mechanisms that can lead to gastrointestinal symptoms in patients with irritable bowel syndrome (IBS) due to their inability to be properly digested.

A personalized approach to dietary adjustments, considering factors like ethnicity and individual symptom profiles, may enhance the effectiveness of low-FODMAP diets in managing IBS symptoms, although more research is needed to identify which patients will benefit from specific dietary restrictions.

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]

Patients with active Crohn's disease consume significantly lower amounts of prebiotic inulin-type fructans and oligofructose compared to those with inactive Crohn's disease and healthy controls, suggesting dietary intake may be affected by disease activity.

There are negative correlations between the intake of these prebiotics and measures of disease severity, indicating that lower consumption may be linked to worse symptoms in active Crohn's disease patients.

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]

In a study of 51 patients with irritable bowel syndrome and constipation (IBS-C), the addition of a food supplement containing inulin, choline, and silymarin (Stoptoxin®) to a specific constipation diet significantly reduced abdominal pain severity by 68.3% and bloating by 34.8%.

While the supplement improved stool frequency and consistency, these changes were not statistically significant, suggesting that while Stoptoxin® has clear benefits for pain and bloating, its effects on stool characteristics may require further investigation.

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]

In a study of 71 children aged 4 to 16 with irritable bowel syndrome (IBS), synbiotic treatment (Bifidobacterium lactis B94 with inulin) showed significant improvements in symptoms like belching, bloating, and constipation compared to prebiotic treatment alone.

The synbiotic group had a higher recovery rate (39.1%) from IBS symptoms compared to the prebiotic group (12.5%), suggesting that synbiotics are more effective for treating IBS in children.

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]