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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ Subjects must meet all of the following inclusion criteria to enter the study:

• Diagnosed with diabetes for over 1 year;

• Accompanied by symptoms such as abdominal bloating, early satiety, persisting for at least 3 months, with a GCSI Total Score greater than/equal to 2.3;

• Objective evidence of delayed gastric emptying within the past 3 months, including but not limited to scintigraphic gastric emptying or gastric ultrasound;

• Upper gastrointestinal obstructive lesions were ruled out by imaging or endoscopic examination within the past 3 months;

• Males and nonpregnant, non-breastfeeding females who are aged more than 18 years and sign the informed consent form;

• The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.

Locations
Other Locations
China
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Faming Zhang, PhD
fzhang@njmu.edu.cn
086-025-58509883
Backup
Bota Cui
cuibota@njmu.edu.cn
086-025-58509884
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2029-07
Participants
Target number of participants: 46
Treatments
Experimental: Treatment
The patient will receive WMT once daily for a duration of 2 days
Placebo_comparator: Control
The patient will receive a placebo of equal volume once daily for a duration of 2 days
Related Therapeutic Areas
Sponsors
Leads: The Second Hospital of Nanjing Medical University

This content was sourced from clinicaltrials.gov