RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: FODMAP Challenge for Irritable Bowel Syndrome (IBS)

Q: Is NCT07688044 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07688044?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07688044?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

Irritable Bowel Syndrom (IBS) affects up to five percent of Canadians and has proven difficult to treat. Our research will explore how a type of dietary carbohydrate, called FODMAPS, contributes to chronic abdominal pain in irritable bowel syndrome (IBS).

Official registry: https://clinicaltrials.gov/study/NCT07688044 · David Reed · enrollment listed as 60

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are FODMAP Challenge. The registry lists allocation as na. Irritable Bowel Syndrom (IBS) affects up to five percent of Canadians and has proven difficult to treat.

They plan to enroll about 60 people at Kingston. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

The Role of Gut Microbiota in Patient Responses to a Dietary Therapy for Abdominal Pain

Interventions: FODMAP Challenge

Primary outcome (registry wording): Change in Dorsal Root Ganglion (DRG) neuron rheobase by chemostat supernatant

Who it is for (from inclusion criteria)

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

Who the registry excludes

Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.) as some symptoms may be related to their disease and not IBS
Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection
Major gastrointestinal surgery (e.g. Roux en y, bowel resection) as symptoms may be related to previous surgery rather than IBS
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
History of active cancer in the last 5 years, other than basal cell cancer as the treatment may have impacted the GI tract
Pregnant or breastfeeding women
Active or recent participation (\< 1 month) in a clinical study

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

1 listed

Hotel Dieu Hospital — Kingston, Ontario, Canada (recruiting)

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FAQ about this NCT record

Is NCT07688044 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07688044?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07688044?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary