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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how inulin, a type of fiber, affects gut bacteria and digestive processes in individuals with irritable bowel syndrome (IBS). Researchers aim to determine if changes in gut bacteria and the production of certain acids in the gut are linked to IBS symptoms. Participants will include individuals with IBS, either diarrhea- or constipation-predominant, and healthy individuals without gut issues. Those who have IBS symptoms and meet the Rome IV criteria (guidelines for diagnosing IBS) or are healthy with no digestive problems may be suitable candidates. As an unphased trial, this study seeks to explore new insights into IBS, offering participants the opportunity to contribute to groundbreaking research.

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.

Is there any evidence suggesting that inulin is likely to be safe for humans?

Studies have shown that inulin, a type of dietary fiber, is generally easy for people to tolerate. Inulin supports good bacteria, improving gut health. Some individuals might experience mild side effects like bloating or gas, but these usually subside and often occur if introduced too quickly. Research indicates that daily fiber supplements like inulin are safe. However, one study found that a different type of fiber used in another trial caused more side effects and worsened symptoms for some individuals with IBS. Overall, inulin is considered safe for most people, but starting slowly and observing the body's response is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for irritable bowel syndrome (IBS) focus on managing symptoms with medications like antispasmodics, laxatives, or anti-diarrheal drugs. However, inulin is unique because it is a natural dietary fiber that may help balance gut bacteria, which is thought to play a role in IBS symptoms. Researchers are excited about inulin because it offers a potentially more natural approach by promoting healthy digestion and gut health, rather than simply masking symptoms. Its ability to support a healthier gut environment could make it a promising alternative or complement to existing therapies.

What evidence suggests that inulin might be an effective treatment for irritable bowel syndrome?

Research has shown that inulin, a type of soluble fiber, can help alleviate irritable bowel syndrome (IBS) symptoms. Studies have found that inulin can increase weekly bowel movements and improve stool consistency, benefiting those with IBS. One study found that inulin intake made bowel movements more regular and consistent, as measured by the Bristol Stool Form Scale. However, some research suggests that the improvements might not differ significantly from a placebo, indicating that results can vary among individuals. Overall, many guidelines recommend soluble fiber like inulin as a good first step in managing IBS symptoms.

In this trial, researchers will divide participants into groups, including healthy volunteers and IBS patients with either diarrhea (IBS-D) or constipation (IBS-C), to evaluate inulin's effects on these specific conditions. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Regular tobacco use within the past 6 months

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7579772/

Effect of inulin in the treatment of irritable bowel syndrome with ... The beneficial effect is reflected by several indicators of the intestinal habits, such as increased number of stools per week, lower stool consistency ...

2. nature.com nature.com/articles/s41598-025-16321-w

A randomized trial of inulin for bowel symptoms ... Inulin supplementation significantly improves bowel movement frequency and consistency, as assessed by the Bristol Stool Form Scale, in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523069216

Efficacy, safety, and tolerability of fructooligosaccharides in ... Data from 96 patients (16 men and 80 women) were analyzed. After 4–6 wk of treatment, IBS symptoms improved more in the placebo group than in the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5548066/

Dietary fiber in irritable bowel syndrome (Review) - PMC Other studies have shown that while consuming water-insoluble fiber does not improve IBS symptoms, consuming soluble fiber improves overall IBS symptoms (40,41) ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/17474124.2021.1924057

Current evidence on the therapeutic use of fiber in irritable ... The most recent clinical guidelines on the management of IBS consider ispaghula husk, a product containing soluble fiber, as a reasonable first line therapy.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02144753

NCT02144753 | Use of Novel Prebiotic Fiber for Targeted ... Per DSMB, study fiber had given subjects more adverse events and made their IBS symptoms worse than the psyllium group. Use of Novel Prebiotic Fiber for ...

7. mayoclinic.org mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/expert-answers/fiber-supplements/faq-20058513

Fiber supplements: Safe to take every day? Taking fiber supplements every day seems to be safe. Popular fiber supplements include inulin, psyllium (Metamucil, Konsyl, others) and methylcellulose ...