CompletedNot Applicable

Irritable Bowel Syndrome and Food Sensitivity

United States58 participantsStarted 2014-07

Plain-language summary

The primary objective of the clinical trial portion of this study is to assess whether an individualized dietary plan based on a commercial food sensitivity assay provides specific benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between 18-70 years of age. * Irritable Bowel Syndrome by Rome III criteria. * Stable dose (30 days) of concurrent IBS medications * Agree not to make significant changes to their diet during the study * IBS-SSS score of \>150 Exclusion Criteria: * History of major abdominal surgeries * History of inflammatory bowel disease * Antibiotic use within 1 month of enrollment * Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function * Current use of opioid pain medications (except for NSAIDs) * Previous experience participating in dietary studies for IBS * Current use of medications which are known to be affected by modest dietary changes * Vitamin C use of \>2000 mg/day * Quercetin use of \>500 mg/day

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)

Timeframe: Baseline

Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)

Timeframe: 4 weeks

Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)

Timeframe: 8 weeks

Trial details

NCT IDNCT02186743

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.