Clinical Trial

YQD Combined With Plant Lactobacillus for Slow Transit Constipation

Study acronym: YQD-LAC-STC
Completed
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Summary
Slow transit constipation (STC) is a common and difficult-to-treat subtype of chronic constipation, characterized by reduced colonic motility and delayed stool passage. Current treatments often provide limited long-term relief, and many patients relapse after stopping medication. This study aims to evaluate whether combining a traditional Chinese herbal formula (Yìqì Jiànpí Decoction, YQD) with plant-derived Lactobacillus probiotics provides better and more sustained relief than either treatment alone or standard prokinetic therapy. A total of 120 eligible patients with STC will be randomly assigned to four groups in a 1:1:1:1 ratio: (1) YQD + Lactobacillus + mosapride; (2) YQD + mosapride; (3) Lactobacillus + mosapride; (4) mosapride alone. The treatment lasts 8 weeks. The primary outcome is the change in Constipation Severity Score from baseline to week 8. Secondary outcomes include quality of life, colonic transit time, gut microbiota changes, and relapse rate during a 6-month follow-up period. This study will provide evidence on whether an integrative TCM-probiotic strategy offers superior and more durable benefits for STC patients.
Trial Details
NCT Number NCT07757061
Lead Sponsor First People's Hospital Of Lin'an District, Hangzhou
Conditions Constipation, Slow Transit Constipation
Enrollment 120 participants
Start Date 2025-01-01
Primary Completion 2026-06-10 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-12