NCT06106685

Washed Microbiota Transplantation for Chronic Constipation in Adults

Washed Microbiota Transplantation for Chronic Constipation in Adults: a Single-center, Randomized, Double-blind, Placebo-controlled, Dose-exploring Clinical Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, randomized, double-blind, placebo-controlled, dose-exploring clinical study to explore the safety and efficacy of washed microbiota transplantation (WMT) for patients with chronic constipation.

Detailed description

At least 18 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the high-dose group (high dose of washed microbiota suspension), the low-dose group (low dose of washed microbiota suspension) and the control group (placebo). Data of demographic characteristics, intestinal symptoms，medicine treatment usage and clinical outcomes will be collected. After treatment (D1-D4), they will enter the double-blind visit (D5, D18) for safety and efficacy evaluation. Open follow-up periods will be performed on days 32 and 60 after administration.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	High-dose washed microbiota suspension	The high-dose group will be administered a high dose of washed microbiota suspension。
DRUG	Low-dose washed microbiota suspension	The low-dose group will be administered a low dose of washed microbiota suspension.
DRUG	Placebo	The control group will be given equal volume placebo (120ml carrier solution matching the volume of WMT-001), which contains 10% sterile glycerol and saline injection. The drug was administered once a day for 4 days.

Timeline

• Start date: 2023-07-24
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2023-10-30
• Last updated: 2023-10-30

Locations

2 sites across 1 country: China