Your session is about to expire
← Back to Search
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
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 belowSelect...
I am 18-65 with IBS or have no GI issues, fitting specific criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 to 90 days
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 moreSecondary 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
2,356 Previous Clinical Trials
4,314,994 Total Patients Enrolled
23 Trials studying Irritable Bowel Syndrome
3,540 Patients Enrolled for Irritable Bowel Syndrome
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,089 Total Patients Enrolled
3 Trials studying Irritable Bowel Syndrome
5,460 Patients Enrolled for Irritable Bowel Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken antibiotics in the last 3 months.I have had radiation or surgery on my abdomen, but not C-section or similar, over 6 months ago.I am 18-65 with IBS or have no GI disease history.I do not have chronic bowel conditions, uncontrolled thyroid, liver disease, or a history of high liver enzymes.I haven't taken any medication that affects my digestion in the last 6 months.I am not pregnant, trying to become pregnant, or breastfeeding.I am 18-65 with IBS or have no GI issues, fitting specific criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Irritable Bowel Syndrome Patients with Constipation
- Group 2: Healthy volunteers
- Group 3: Irritable Bowel Syndrome Patients with Diarrhea
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Irritable Bowel Syndrome Patient Testimony for trial: Trial Name: NCT03983434 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Missouri
Illinois
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Indiana University
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Have had IBS issues since 2008. In 2015 had surgery and 5 of colon removed. Found an large abscess that was ready to burst. Have a long history of diverticulitis, and a family history of same through my mother. Many aunts and cousins also have issues with diverticulitis. Recently had a 4 month flare up of Lymphocytic colitis.
PatientReceived no prior treatments
Recent research and studies
Popular Categories
Share this study with friends
Copy Link
Messenger