CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 18 target
Drug / intervention
High-dose washed microbiota suspension +2 moredrug
Likely dose
Placebo 120mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06106685
NCT06106685Phase 2RecruitingOn TrackUpdated 32mo ago
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Washed Microbiota Transplantation for Chronic Constipation in Adults: a Single-center, Randomized, Double-blind, Placebo-controlled, Dose-exploring Clinical Study

The Second Hospital of Nanjing Medical University·interventional·Posted Oct 30, 2023·Updated Oct 30, 2023

In Brief

A Phase 2 clinical trial evaluating High-dose washed microbiota suspension, Low-dose washed microbiota suspension, and 1 other intervention for Constipation. Currently recruiting, targeting 18 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
2024202520262027
First PostedOct 30, 2023
Enrollment StartJul 24, 2023
Primary CompletionJul 1, 2026
Study CompletionDec 1, 2026
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 2.7 years ago

Interventions

High-dose washed microbiota suspensiondrug

The high-dose group will be administered a high dose of washed microbiota suspension。

Low-dose washed microbiota suspensiondrug

The low-dose group will be administered a low dose of washed microbiota suspension.

Placebodrug

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.