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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Modified Crohn's Disease Exclusion Diet (CDED) for Irritable Bowel Syndrome (IBS)

Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M).

Official registry: https://clinicaltrials.gov/study/NCT07707635 · Ariel University · enrollment listed as 150

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 Modified Crohn's Disease Exclusion Diet (CDED), or Low FODMAP Diet. The registry lists allocation as randomized. Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden.

They plan to enroll about 150 people at Ramat Gan. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Open-Label, Randomized Controlled Study to Assess the Efficacy of a Modified Crohn's Disease Exclusion Diet (CDED) Versus Low FODMAP Diet for Managing Non-Constipation Irritable Bowel Syndrome

Interventions: Modified Crohn's Disease Exclusion Diet (CDED), Low FODMAP Diet

Primary outcome (registry wording): Proportion of participants achieving a clinically meaningful response (≥50-point reduction in IBS Symptom Severity Score [IBS-SSS])

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Adults, men, and women (≥18 years) are diagnosed with IBS-D or IBS-M according to Rome IV criteria
  • Moderate-to-severe symptoms (IBS-SSS score ≥175)
  • Stable use of any IBS-related medications for ≥6 weeks before study enrollment, except for antibiotics

Public study contact (from the registry)

Keren Hod, RD PhD

+972-53-2214380

kerenho@ariel.ac.il

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT07707635 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 NCT07707635?

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 NCT07707635?

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

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