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A Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Patients With IBS-D

Irritable Bowel Syndrome With Diarrhea Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Live SK08 Powder (Bacteroidetes Fragilis) in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Live SK08 Powder compared with placebo in the treatment of participants with irritable bowel syndrome with diarrhea.

Clinical Trial Description

Irritable Bowel Syndrome (IBS) is a chronic, functional bowel disease characterized by abdominal pain, bloating, or abdominal discomfort. Symptoms may improve after bowel movements, and are often accompanied by changes in bowel habits [frequency and/or fecal trait ]. There is a lack of organic lesions that can be detected by routine clinical examination to explain these symptoms. The pathogenesis of IBS is the result of a combination of factors, including visceral hypersensitivity, intestinal immunity and inflammation, gastrointestinal motility abnormalities, and intestinal flora. SK08 can relieve abdominal pain and diarrhea by protecting intestinal barrier function, regulating immunity (such as reducing inflammatory factors TNF-α etc., promoting macrophages to phagocytosis of pathogenic bacteria), and correcting bacterial imbalance, to achieve the therapeutic effect. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06247046
Study type Interventional
Source Guangzhou Zhiyi Biotechnology Co., Ltd.
Contact Yangyang Liu, Doctor
Phone 020-82258826
Email liuyangyang@zypharm.com.cn
Status Recruiting
Phase Phase 3
Start date March 16, 2024
Completion date January 2027
View Details
See also
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