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Washed Microbiota Transplantation for Chronic Constipation in Adults

NCT06106685 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-10-30

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • The Second Hospital of Nanjing Medical University

    lead OTHER

Principal Investigators

  • Faming Zhang · The Second Hospital of Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06106685 on ClinicalTrials.gov