NCT06340217

Washed Microbiota Transplantation for Diabetic Gastroparesis

The Efficacy and Safety of WMT in the Treatment of Diabetic Gastroparesis: A Multicenter, Randomized, Double-blind, Placebo-controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.

Detailed description

At least 44 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, Gastroparesis Cardinal Symptom Index (GCSI), Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM), Gastroparesis Core Symptom Daily Diary (GCS-DD), Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL), and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.

Conditions

• Diabetic Gastroparesis

Interventions

Type	Name	Description
OTHER	washed microbiota transplantation	Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive two doses of WMT for DGP.
OTHER	placebo	A carrier fluid with matching volume and consistent appearance to the infusion of washed microbiota.

Timeline

• Start date: 2024-04-01
• Primary completion: 2029-01-01
• Completion: 2029-07-01
• First posted: 2024-04-01
• Last updated: 2025-09-10

Locations

1 site across 1 country: China