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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: High Protein, High Fiber (HPHF) Diet for Ulcerative Colitis

The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.

Official registry: https://clinicaltrials.gov/study/NCT07520461 · University of Minnesota · enrollment listed as 40

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 High Protein, High Fiber (HPHF) Diet. The registry lists allocation as na. The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.

They plan to enroll about 40 people at Minneapolis. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Microbiome-targeted Diet Therapy in Ulcerative Colitis

Interventions: High Protein, High Fiber (HPHF) Diet

Primary outcome (registry wording): Fecal H2S Production

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Age at least 18 years old
  • Diagnosis of UC based on clinical and endoscopic criteria
  • UC duration of at least 3 months
  • Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization
  • On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below)
  • ≥4 weeks if no medication, 5-ASA
  • ≥8 wk for immunomodulatory therapy

Public study contact (from the registry)

Lulu Chen

612-301-8294

chen8124@umn.edu

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

Sites listed on ClinicalTrials.gov

1 listed

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NCT06006039 · Official ClinicalTrials.gov record · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

FAQ about this NCT record

Is NCT07520461 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 NCT07520461?

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 NCT07520461?

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