How certain FODMAPs affect IBS pain in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with IBS follow a low-FODMAP diet and then subtypes of FODMAPs are reintroduced to see which ones increase pain, while stool samples help explore gut bacteria and other mediators. The study aims to separate the roles of diet and the microbiome in IBS pain signaling. Participants are monitored for changes in belly pain and related symptoms during the reintroduction phase. The trial will help identify targeted dietary strategies for reducing pain in IBS patients. It is conducted at Hotel Dieu Hospital in Kingston with sponsorship from the Weston Family Foundation and led by investigator David Reed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18-70 with IBS (Rome IV (now V) criteria)
* PROMIS belly pain score \>12

Exclusion Criteria:

1. Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.) as some symptoms may be related to their disease and not IBS.
2. Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
3. Major gastrointestinal surgery (e.g. Roux en y, bowel resection) as symptoms may be related to previous surgery rather than IBS.
4. Body mass index above 35 kg/m2 as it is unknown how mediators in the GI tract that may be involved in pain signaling in the gut are affected by obesity.
5. History of active cancer in the last 5 years, other than basal cell cancer as the treatment may have impacted the GI tract.
6. Pregnant or breastfeeding women.
7. Active or recent participation (\< 1 month) in a clinical study.
8. Use of antibiotics, probiotics, during, or one month prior to the study as may affect gut microbiota.
9. Use of new medications less than 4 weeks prior to the study as may alter gut microbiota and/or IBS symptoms.
10. Allergies to any of the ingredients used in the study.
11. Any immune-compromising conditions as may affect GI symptoms.
12. Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorders as participating in a diet challenge study may have negative impact on these disorders.

Where it's running

• Hotel Dieu Hospital
  Kingston, Ontario, Canada Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.