Study of Probiotic 6600 to Improve Colitis, Ulcerative Colitis, and Crohns Disease Randomized, Double-Blind, Placebo-Controlled Trial in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the use of Probiotic 6600 as an additional treatment for people with colitis, including ulcerative colitis UC, Crohns disease CD, and other types of colitis. This study is designed as a multicenter, randomized, double-blind, placebo-controlled trial conducted in two phases to assess whether taking Probiotic 6600 capsules improves clinical remission rates after 24 weeks when added to usual care. The study focuses on important remission scores such as the SCCAI, Mayo, and CDAI to measure disease activity. Participants are randomly assigned in equal numbers to receive either Probiotic 6600 capsules or placebo capsules. Both treatments are taken orally twice daily after meals with warm water for 24 weeks. The study includes a screening period of one week before treatment, a one-day exit examination after treatment, and a four-week safety follow-up. Different groups include patients diagnosed with UC, CD, or other colitis, each receiving either the probiotic or placebo. During the study, participants will undergo clinical evaluations to assess remission status using standard scoring systems. Medical history and adherence to treatment are monitored, and safety is followed for four weeks after treatment ends. The primary outcome measures the rate of clinical remission after 24 weeks of treatment. Participation lasts from screening through treatment and follow-up, with careful monitoring of health status and study compliance throughout the process.

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