Cure8 trial brief
Why This Matters
People with UC in remission who still have gut–brain interaction symptoms often look for safe ways to improve symptoms or gut microbiota balance.
This trial tests a targeted bacterial supplement and will measure both microbiome changes and clinical markers (fecal calprotectin, symptom scores), which could be relevant if results show clinical benefit and safety.
Who Should Pay Attention
Adults with ulcerative colitis in remission who have IBS-like symptoms or other DGBI; gastroenterology clinicians and researchers interested in microbiome-targeted supplements and biomarker-based outcomes.
Study Snapshot
What To Know
This is a not-yet-recruiting randomized, double-blind, placebo-controlled crossover trial based at the University of Padova planning to enroll about 50 participants aged 18–70 with confirmed UC in remission and concurrent DGBI. Participants will take two tablets per day of Colipral (E. coli 5C LMG S-33222) or matching placebo for 60 days, then cross over.
Primary outcomes focus on microbiota composition (16S rRNA from stool); secondary outcomes include fecal calprotectin and validated symptom and quality-of-life questionnaires (IBDQ, IBS-SSS, VAS, Bristol Stool Scale). Design notes: Because this is a trial record, there are no reported results here.
The trial excludes recent antibiotic or probiotic use and people on restrictive diets, and it requires remission for at least six months. Enrollment status at the time of the record is not-yet-recruiting.
Keep In Mind
This is a registered interventional trial record without posted results; planned enrollment is ~50 and the study is not yet recruiting. The primary outcome is microbiome composition by 16S sequencing — changes there do not necessarily translate into clinical benefit.
the intervention is labeled as a food supplement and the trial excludes recent antibiotic/probiotic users and those on restrictive diets.
Source Details
Review the original publication for the complete reporting, methods, and context.
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.