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Prebiotic

Inulin Diet Challenge for Irritable Bowel Syndrome

N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
Be older than 18 years old
Must not have
Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT > 2.0x the upper limit of normal
Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients. Rescue therapy to facilitate stool collection will be permitted where needed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 to 90 days
Awards & highlights

Study Summary

This trial looks at bile acid, fatty acid and gut bacteria levels to see if they are linked to IBS, compared to healthy people.

Who is the study for?
This trial is for adults aged 18-65 with Irritable Bowel Syndrome (IBS) who meet the Rome IV criteria, and healthy individuals without GI diseases. Participants should not be on extreme diets like gluten-free or low FODMAP, nor have had certain abdominal surgeries, used tobacco recently, be pregnant/breastfeeding, taken antibiotics within 3 months or medications affecting GI function within 6 months.Check my eligibility
What is being tested?
The study tests how a dietary component called Inulin affects the gut's bacteria, bile acids, and short chain fatty acids in IBS patients compared to healthy people. It aims to understand if stool bacterial composition changes correlate with these substances differently in those with IBS.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of taking Inulin may include bloating, gas, discomfort in the abdomen and an increased frequency of bowel movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18-65 with IBS or have no GI issues, fitting specific criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have chronic bowel conditions, uncontrolled thyroid, liver disease, or a history of high liver enzymes.
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I haven't taken any medication that affects my digestion in the last 6 months.
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I am not pregnant, trying to become pregnant, or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 to 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fecal inulin
Fecal microbial population
Individual fecal short chain fatty acids
+2 more
Secondary outcome measures
Percent primary fecal bile acids
Stool characteristics
Other outcome measures
24-hour diet (food intake) recall

Trial Design

3Treatment groups
Experimental Treatment
Group I: Irritable Bowel Syndrome Patients with DiarrheaExperimental Treatment1 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 ConstipationExperimental Treatment1 Intervention
Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS
Group III: Healthy volunteersExperimental Treatment1 Intervention
Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inulin
2011
Completed Phase 4
~780

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,381 Previous Clinical Trials
4,315,071 Total Patients Enrolled
23 Trials studying Irritable Bowel Syndrome
3,538 Patients Enrolled for Irritable Bowel Syndrome
Indiana UniversityLead Sponsor
997 Previous Clinical Trials
1,095,563 Total Patients Enrolled
3 Trials studying Irritable Bowel Syndrome
5,226 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Inulin (Prebiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03983434 — N/A
Irritable Bowel Syndrome Research Study Groups: Irritable Bowel Syndrome Patients with Constipation, Healthy volunteers, Irritable Bowel Syndrome Patients with Diarrhea
Irritable Bowel Syndrome Clinical Trial 2023: Inulin Highlights & Side Effects. Trial Name: NCT03983434 — N/A
Inulin (Prebiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03983434 — N/A
Irritable Bowel Syndrome Patient Testimony for trial: Trial Name: NCT03983434 — N/A
~5 spots leftby Jul 2025
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