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

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 2, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
121 trials monitored
See 1 trial at risk
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 informed consent, participants who met the inclusion criteria and those who did not meet the exclusion criteria were randomly assigned, in a 1:1 ratio, to receive either the trial (probiotic 6600 capsules) or the control group (placebo). The clinical remission rate (SCCAI score ≤2 and no single subscore \>1) after 24 weeks of treatment was calculated. Mayo score ≤2 and no single subscore \>1; CDAI score ≤2 and no single subscore \>1) were used as the primary efficacy index.
Trial Details
NCT Number NCT07047339
Lead Sponsor Changhai Hospital
Conditions
(from sponsor)
Colitis, IBD (Inflammatory Bowel Disease), Probiotic Intervention
Related terms Colitis, Inflammatory Bowel Diseases
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov