YQD Combined With Plant Lactobacillus for Slow Transit Constipation

NCT07757061 | Completed

• 1 other identifier: 2025ZX108
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Constipation; Slow Transit Constipation

Keywords

Slow Transit Constipation; Yìqì Jiànpí Decoction; Traditional Chinese Medicine; Lactobacillus; Probiotics; Gut Microbiota; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Constipation Severity Score (CSS)

  The Constipation Severity Score (CSS) evaluates five dimensions: stool frequency, stool consistency, straining, abdominal pain, and use of aids to defecation. Higher scores indicate greater severity. The outcome is measured as the change from baseline to week 8 (Week 8 score minus Baseline score).

  Baseline to Week 8

Secondary Outcomes (5)

• Change in Patient Assessment of Constipation Quality of Life (PAC-QOL) Score

  Baseline to Week 8

• Change in Colonic Transit Time - Percentage of Retained Markers at 72 Hours

  Baseline to Week 8

• Change in Gut Microbiota Quantification

  Baseline to Week 8

• Relapse Rate During 6-Month Follow-Up

  Month 1, Month 3, and Month 6 post-treatment

• Incidence of Treatment-Related Adverse Events

  Week 0 through Month 6 post-treatment

Study Arms (4)

YQD + Lactobacillus + Mosapride

EXPERIMENTAL

Participants receive Yìqì Jiànpí Decoction (YQD) once daily, plant-derived Lactobacillus tablets (3 tablets twice daily), and mosapride citrate 5 mg three times daily for 8 weeks.

Dietary Supplement: YQD (Yìqì Jiànpí Decoction); Dietary Supplement: Plant-derived Lactobacillus; Drug: Mosapride Citrate

YQD + Mosapride

ACTIVE COMPARATOR

Participants receive Yìqì Jiànpí Decoction (YQD) once daily and mosapride citrate 5 mg three times daily for 8 weeks. (No probiotics)

Dietary Supplement: YQD (Yìqì Jiànpí Decoction); Drug: Mosapride Citrate

Lactobacillus + Mosapride

ACTIVE COMPARATOR

Participants receive plant-derived Lactobacillus tablets (3 tablets twice daily) and mosapride citrate 5 mg three times daily for 8 weeks. (No herbal decoction)

Dietary Supplement: Plant-derived Lactobacillus; Drug: Mosapride Citrate

Mosapride Alone

ACTIVE COMPARATOR

Participants receive mosapride citrate 5 mg three times daily for 8 weeks as active comparator. (No herbal decoction, no probiotics)

Drug: Mosapride Citrate

Interventions

YQD (Yìqì Jiànpí Decoction) DIETARY_SUPPLEMENT

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.

YQD + Lactobacillus + Mosapride; YQD + Mosapride

Plant-derived Lactobacillus DIETARY_SUPPLEMENT

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.

Lactobacillus + Mosapride; YQD + Lactobacillus + Mosapride

Mosapride Citrate DRUG

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

Lactobacillus + Mosapride; Mosapride Alone; YQD + Lactobacillus + Mosapride; YQD + Mosapride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the Rome IV criteria for functional constipation, with predominant slow transit type confirmed by a colon transit study (retention of ≥20% of markers at 72 hours).
• Age between 18 and 75 years.
• Ability to comply with study procedures and provide written informed consent.
• No use of antibiotics, probiotics, or other laxatives (except rescue) within 2 weeks before enrollment.

You may not qualify if:

• Outlet obstruction constipation (confirmed by anorectal manometry or defecography).
• Secondary constipation due to organic diseases (e.g., colorectal cancer, inflammatory bowel disease).
• History of abdominal surgery (except appendectomy or cholecystectomy).
• Severe systemic illness (e.g., heart failure, renal failure, liver cirrhosis).
• Pregnancy or lactation.
• Known allergy to any herbal ingredient or Lactobacillus preparation.
• Use of medications affecting gastrointestinal motility (e.g., opioids, anticholinergics) within 4 weeks before screening.

Sponsors & Collaborators

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

Study Sites (1)

Department of Colorectal Surgery, The First People's Hospital of Lin'an District, Hangzhou

Hangzhou, Zhejiang, 311300, China

Location

Related Publications (4)

• Jiang D, Zhang J, Xia Z. Structural Advances in Voltage-Gated Sodium Channels. Front Pharmacol. 2022 Jun 3;13:908867. doi: 10.3389/fphar.2022.908867. eCollection 2022.

  PMID: 35721169 RESULT

• Narayanan V, Motlekar S, Kadhe G, Bhagat S. Efficacy and safety of nadifloxacin for bacterial skin infections: results from clinical and post-marketing studies. Dermatol Ther (Heidelb). 2014 Dec;4(2):233-48. doi: 10.1007/s13555-014-0062-1. Epub 2014 Sep 12.

  PMID: 25212256 RESULT

• Dou X, Yang W, Ding Q, Han Q, Qian Q, Du Z, Fan Y, Wang C, Li S. Comprehensive Analysis of the Expression Profiles of Hepatic lncRNAs in the Mouse Model of Alcoholic Liver Disease. Front Pharmacol. 2021 Jul 29;12:709287. doi: 10.3389/fphar.2021.709287. eCollection 2021.

  PMID: 34393788 RESULT

• Foja S, Heinzelmann J, Viestenz A, Rueger C, Hecht S, Viestenz A. Evaluation of the Possible Influence of Povidone Iodine (PVI) Solution and Polyhexanide (PHMB) on Wound Healing in Corneal Epithelial Regeneration. J Clin Med. 2024 Jan 19;13(2):588. doi: 10.3390/jcm13020588.

  PMID: 38276094 RESULT

MeSH Terms

Conditions

Constipation

Interventions

mosapride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yongjian Liao, MD

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors (endoscopist, laboratory technicians, and statistician) are blinded to group allocation. Participants are instructed not to disclose their treatment to assessors. The herbal decoction and probiotics are prepared and dispensed by a separate pharmacy team not involved in outcome evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Colorectal Surgery

Model Details: Participants are randomized to one of four parallel groups in a 1:1:1:1 allocation ratio.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start: January 1, 2025
• Primary Completion: June 10, 2026
• Study Completion: August 1, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)