NCT06247046

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,298 (estimated)
• Sponsor: Guangzhou Zhiyi Biotechnology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
DRUG	Live SK08 powder	Oral Powder
DRUG	Placebo	Oral Powder

Timeline

• Start date: 2024-03-16
• Primary completion: 2026-04-01
• Completion: 2027-01-01
• First posted: 2024-02-07
• Last updated: 2025-04-03

Locations

2 sites across 1 country: China