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

NCT06340828 | Not Yet Recruiting

• 1 other identifier: 2023-KY-186-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Gastroparesis; Diabetic Gastropathy; Diabetic Gastroenteropathy; Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Gastroparesis Cardinal Symptom Index

  0 days，weeks 1, 4, and 12 post-treatment

• Composite Autonomic Symptom Score 31

  0 days，weeks 1, 4, and 12 post-treatment

• Gastrointestinal Motility

  0 days，weeks 12 post-treatment

• Heart Rate Variability

  0 days，weeks 12 post-treatment

• Serum Metabolites

  0 days，weeks 12 post-treatment

Study Arms (1)

Washing Microbiota Transplantation (WMT) group

EXPERIMENTAL

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

Interventions

Washing Microbiota Transplantation OTHER

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.

Also known as: Fecal Microbiota Transplantation

Washing Microbiota Transplantation (WMT) group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Sijing Wang, Master's student

CONTACT

+8615664579913; 15664579913@163.com

Dafa Ding, Professor

CONTACT

+8615850514014; dingdafa@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 2, 2024
• Study Start: April 20, 2024
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

CN (1)