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Dietary Supplement
Inulin for Irritable Bowel Syndrome
N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-75
Healthy volunteers (healthy controls) with no prior history of gastrointestinal (GI) disease or symptoms
Must not have
Use of any prescription, over the counter, or herbal medications known to affect gastrointestinal function or study interpretation, such as opioids, inflammatory drugs or certain antidepressants, within 6 months prior to study participation for healthy volunteers, or within 2 days of study participation for participants with IBS
Use of Ozempic and Ozempic-type medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial will look at how different types of bacteria in the gut are related to irritable bowel syndrome (IBS). The researchers believe that changes in gut bacteria can affect certain substances in the colon,
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Inulin may cause digestive discomfort such as bloating, gas, or altered bowel habits, especially in individuals with IBS.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I am healthy with no history of stomach or intestine diseases.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken medications that affect my stomach or study results in the last 6 months.
Select...
I am currently taking Ozempic or similar medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fecal inulin
Fecal microbial population
Individual fecal short chain fatty acids
+2 moreSecondary study objectives
Percent primary fecal bile acids
Stool characteristics
Other study objectives
24-hour diet (food intake) recall
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Irritable Bowel Syndrome Patients with Diarrhea (IBS-D)Experimental 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 Constipation (IBS-C)Experimental 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?
University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,223 Total Patients Enrolled