Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis
Status:
RECRUITING
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
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.