Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340217
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-03-25
Brief Title:
Washed Microbiota Transplantation for Diabetic Gastroparesis
Sponsor:
The Second Hospital of Nanjing Medical University
Organization:
The Second Hospital of Nanjing Medical University
Study Overview
Official Title:
The Efficacy and Safety of WMT in the Treatment of Diabetic Gastroparesis A Multicenter Randomized Double-blind Placebo-controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None