Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis

Recruiting Phase 2 Phase 3 Interventional Study
Colitis IBD (Inflammatory Bowel Disease) Probiotic Intervention
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Changhai Hospital · Other
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About This Trial
This study was conducted in two phases. In Phase I, 40 UC participants, 40 CD participants, and 40 colitis participants were randomly assigned in a 1:1 ratio to the experimental group and the control group, respectively. The study included a screening period (1 week), a double-blind treatment period (24 weeks), an exit examination (1 day), and a safety follow-up period (4 weeks). After providing i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Ulcerative colitis (UC) : met the clinical diagnostic criteria of UC "Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi 'an)", and modified Mayo score ≥4 points; 2. Crohn's disease (CD) : met the clinical diagnostic criteria of CD "Chinese Gui…
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