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YQD Combined With Plant Lactobacillus for Slow Transit Constipation

NCT07757061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

YQD (Yìqì Jiànpí Decoction)

A 12-herb traditional Chinese medicine formula consisting of Cistanche deserticola (Roucongrong) 15 g, Atractylodes macrocephala (Baizhu) 15 g, Astragalus membranaceus (Huangqi) 20 g, Cynanchum wilfordii (Geshangiao) 15 g, Scrophularia ningpoensis (Xuanshen) 12 g, Raphanus sativus (Laifuzi) 15 g, Dioscorea opposita (Shanyao) 12 g, Galli Gigerii Endothelium Corneum (Jineijin) 15 g, Sesamum indicum (Heizhima) powder 12 g, Cyathula officinalis (Chuanniuxi) 15 g, Massa Medicata Fermentata (Shenqu) 15 g, and Colla Corii Asini (Ejiao) 12 g. One dose is immersed in 1000 mL distilled water for 30 min, boiled, then simmered for 30 min, filtered; the residue is re-boiled with another 1000 mL, combined, and concentrated to 100 mL. Patients take the entire 100 mL once daily in the morning for 8 weeks.

DIETARY_SUPPLEMENT

Plant-derived Lactobacillus

Commercially available compound Lactobacillus tablets containing ≥10⁹ CFU of plant-derived Lactobacillus strains per tablet. Patients take 3 tablets twice daily (morning and evening) for 8 weeks.

DRUG

Mosapride Citrate

Mosapride citrate 5 mg tablets taken orally three times daily before meals for 8 weeks.

Sponsors & Collaborators

  • First People's Hospital Of Lin'an District, Hangzhou

    lead OTHER

Principal Investigators

  • Yongjian Liao, MD · First People's Hospital of Hangzhou

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-06-10
Completion
2026-08-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757061 on ClinicalTrials.gov