A Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Patients With IBS-D
NCT06247046 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1298
Last updated 2025-04-03
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.
Conditions
- Irritable Bowel Syndrome With Diarrhea
Interventions
- DRUG
-
Live SK08 powder
Oral Powder
- DRUG
-
Oral Powder
Sponsors & Collaborators
-
Guangzhou Zhiyi Biotechnology Co., Ltd.
lead OTHER
Principal Investigators
-
Minhu Chen, Doctor · First Affiliated Hospital, Sun Yat-Sen University
-
Yinglian Xiao, Doctor · First Affiliated Hospital, Sun Yat-Sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-16
- Primary Completion
- 2026-04-30
- Completion
- 2027-01-31
Countries
- China
Study Locations
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