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Dietary Intervention for Irritable Bowel Syndrome

N/A
Waitlist Available
Led By Lin Chang, MD
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
Adults (18+ years or older) with a diagnosis of IBS-D or IBS-M based on Rome IV criteria
Diarrhea must occur 2 or more days per week
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily, during weeks 5-7 (reintroduction phase)
Awards & highlights

Study Summary

This trial will help determine the amount and timing of FODMAPs, specifically fructose, that can be safely introduced into the diet of IBS patients.

Eligible Conditions
  • Irritable Bowel Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are 18 years or older and have been diagnosed with IBS-D or IBS-M based on Rome IV criteria.
Select...
You experience diarrhea at least twice a week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily, during weeks 5-7 (reintroduction phase)
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily, during weeks 5-7 (reintroduction phase) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adequate relief of IBS symptoms in past 7 days
Highest amount of grams of sugar in solutions that do not significantly increase IBS symptoms
Secondary outcome measures
Immunoblotting
Change in Personal Health Questionnaire (PHQ-15)
Change in Visceral Sensitivity Index (VSI)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 100% FructoseExperimental Treatment1 Intervention
The fructose group will help to determine whether an absolute amount of fructose will lead to IBS symptoms.
Group II: Fructose and GlucoseActive Control1 Intervention
The glucose/fructose mixture group is a cross comparison group that will determine whether the relative excess fructose concentration is an important cause of IBS symptoms.
Group III: 100% GlucosePlacebo Group1 Intervention
The glucose group will serve as a control since glucose is not a FODMAP and as a result is not expected to lead to recurrent symptoms.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,521 Previous Clinical Trials
10,278,906 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
1,198 Patients Enrolled for Irritable Bowel Syndrome
Lin Chang, MDPrincipal InvestigatorUniversity of California, Los Angeles
4 Previous Clinical Trials
140 Total Patients Enrolled
2 Trials studying Irritable Bowel Syndrome
93 Patients Enrolled for Irritable Bowel Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025