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Dietary Intervention

Low FODMAP Diet for Irritable Bowel Syndrome

N/A
Recruiting
Led By Prashant Singh
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial is testing whether dietary changes can improve symptoms of Irritable Bowel Syndrome.

Who is the study for?
This trial is for adults with Irritable Bowel Syndrome (IBS) who have significant symptoms, as shown by a specific score. They must not have inflammatory bowel disease, celiac disease, or a history of certain gut surgeries and should not be pregnant or allergic to foods. Participants shouldn't have taken antibiotics recently or be on diets like gluten-free in the past 6 months.Check my eligibility
What is being tested?
The study tests if a low FODMAP diet can improve IBS symptoms by causing changes in the colon lining. Participants will follow this special diet that limits certain carbohydrates for four weeks to see if it helps manage their diarrhea-predominant IBS.See study design
What are the potential side effects?
A low FODMAP diet may lead to initial discomfort such as constipation due to dietary changes. Some individuals might experience hunger or dissatisfaction with the dietary restrictions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had a colonoscopy in the last year that ruled out inflammatory bowel disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lactulose Mannitol excretion
Secondary outcome measures
Changes in epithelial permeability
Changes in stool microbiome

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study patients with IBS-DExperimental Treatment1 Intervention
Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,787 Previous Clinical Trials
6,365,484 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
902 Patients Enrolled for Irritable Bowel Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,348 Previous Clinical Trials
4,314,682 Total Patients Enrolled
23 Trials studying Irritable Bowel Syndrome
3,562 Patients Enrolled for Irritable Bowel Syndrome
Prashant SinghPrincipal Investigator - University of Michigan
University of Michigan C.S. Mott Children's Hospital, University of Michigan Health System, University of Michigan Hospital, Von Voigtlander Women's Hospital

Media Library

Low FODMAP Diet (Dietary Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04542018 — N/A
Irritable Bowel Syndrome Research Study Groups: Study patients with IBS-D
Irritable Bowel Syndrome Clinical Trial 2023: Low FODMAP Diet Highlights & Side Effects. Trial Name: NCT04542018 — N/A
Low FODMAP Diet (Dietary Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04542018 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment necessitate a minimum age requirement of eighteen years?

"The trial necessitates that patients between the age of 18 and 65 join, but there are alternative studies for those outside this range--405 trials for minors and 1045 for seniors."

Answered by AI

Are additional participants still being taken into this research program?

"Affirmative. Clinicaltrials.gov provides evidence that this study, which was initially made public on August 3rd 2020, is currently enrolling volunteers. Approximately 50 participants are needed from a single location."

Answered by AI

Who meets the criteria for enrollment in this clinical study?

"In order to be eligible for the trial, individuals should demonstrate symptoms of irritable bowel syndrome and fall into the age range of 18 to 65. As of now, there are about 50 slots open for participation."

Answered by AI

How many participants have been recruited to participate in this trial?

"Affirmative. According to the clinicaltrials.gov website, this research is actively enrolling participants - having been first posted on August 3rd 2020 and recently updated on May 27th 2022. The study necessitates 50 individuals from 1 medical centre."

Answered by AI
~1 spots leftby May 2024