Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study

The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:

• The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests.
• The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria.
• The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.
• The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.

Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Gastroparesis; Diabetic Gastroenteropathy; Diabetic Gastropathy; Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Washing Microbiota Transplantation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sijing Wang, Master's student; Phone Number: +8615664579913; Email: 15664579913@163.com
• Study Contact Backup: Name: Dafa Ding, Professor; Phone Number: +8615850514014; Email: dingdafa@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The Second Affiliated Hospital of Nanjing Medical University
      • Contact: Dafa Ding, Professor; Phone Number: +8615850514014; Email: dingdafa@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.
• Glycated hemoglobin (HbA1c) < 11.0%.

Exclusion Criteria:

• Insulin dependent diabetes;
• Active infections, antibiotics-using, inflammatory bowel disease, irritable bowel syndrome, or other severe gastrointestinal organic disease;
• Severe diabetic complications;
• Thyroid disease, malignancies, severe cognitive impairment and mental disease;
• Alcohol or substance abuse;
• Pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Washing Microbiota Transplantation (WMT) group; After assessing the general condition and gastrointestinal symptoms of the patients upon admission, consecutive days of washing microbiota transplantation were conducted. The administration time was 3 p.m., administered via a nasogastric tube at a dosage of 50 ml per administration. A follow-up appointment at the hospital was scheduled for week 12 post-treatment to reinforce the therapeutic effect with a second treatment, following the same timing, dosage, and administration route as the first treatment.

Other: Washing Microbiota Transplantation; Fecal samples from healthy adults were collected and underwent multiple centrifugations and filtrations to obtain a bacterial solution, which was then transplanted into the duodenum of patients via a nasogastric tube.; Other Names: Fecal Microbiota Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Symptom Rating Scale	Questionnaires，the minimum score is 0，and maximum is 45, and higher scores mean a worse outcome.	0 days，weeks 1, 4, and 12 post-treatment
Gut Microbiome Sequencing	16S rRNA Sequencing	0 days，weeks 12 post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroparesis Cardinal Symptom Index	Questionnaires，the minimum score is 0，and maximum is 45, and higher scores mean a worse outcome.	0 days，weeks 1, 4, and 12 post-treatment
Composite Autonomic Symptom Score 31	Questionnaires，the minimum score is 0，and maximum is 75, and higher scores mean a worse outcome.	0 days，weeks 1, 4, and 12 post-treatment
Gastrointestinal Motility	Neurophysiological Method	0 days，weeks 12 post-treatment
Heart Rate Variability	Neurophysiological Method	0 days，weeks 12 post-treatment
Serum Metabolites	Liquid chromatography-mass spectrometry (LC-MS)	0 days，weeks 12 post-treatment

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2024
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 30, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Neurologic Manifestations; Endocrine System Diseases; Stomach Diseases; Diabetes Mellitus; Paralysis; Diabetes Mellitus, Type 2; Gastrointestinal Diseases; Digestive System Diseases; Gastroparesis
• Other Study ID Numbers: 2023-KY-186-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No