Washed Microbiota Transplantation for Chronic Constipation in Adults

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Constipation

Clinical Trial Details

NCT number	NCT06106685
Study type	Interventional
Source	The Second Hospital of Nanjing Medical University
Contact	Faming Zhang, PhD
Phone	086-025-58509883
Email	fzhang@njmu.edu.cn
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	July 24, 2023
Completion date	December 2026

View Details

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