ClinicalTrials.gov
Cure8 trial brief
Gluten-free Diet in PSC and IBD
Diet and lifestyle
Microbiome
Clinical Trial Phase 1
Adult patients
Clinicians
Researchers
Inflammatory bowel disease
Ulcerative colitis
Why This Matters
Dietary change is a low-risk intervention many patients try; this trial specifically tested whether a gluten-free diet affects liver disease markers, intestinal inflammation, and the gut microbiome in PSC and UC patients.
Who Should Pay Attention
Adults with PSC, people with ulcerative colitis interested in dietary strategies, gastroenterologists/hepatologists, and researchers studying the microbiome and diet in autoimmune disease.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment51 participants
Study statusCompleted
Source depthTrial registry record
What To Know
This is a prospective, self-controlled, single-center study that enrolled adults (18–65) with PSC and a separate group with UC. Participants followed their habitual diet for six months, then a gluten-free diet for 12 months.
Primary outcomes included change in cholestasis lab markers (alkaline phosphatase) and changes in intestinal microbiome composition measured by 16S rRNA sequencing. The registry lists common clinical eligibility and exclusion criteria (for example, excluding people already on a GFD or with celiac disease).
The trial is listed as COMPLETED on ClinicalTrials.gov and was conducted at the Institute of Clinical and Experimental Medicine in Prague. The registry provides protocol details (design, durations, outcomes) but does not report results in this record.
Keep In Mind
The ClinicalTrials.gov record describes the study design and planned outcomes but does not include trial results. Consider looking for a linked publication or posted results for evidence of effects before changing clinical care.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorInstitute for Clinical and Experimental Medicine
Trial IDNCT06026449
Study typeInterventional
Trial phaseNA
Enrollment51 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 13, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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