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

Diabetic Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06340828
• Other study ID #: 2023-KY-186-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: July 20, 2027

Study information

• Verified date: March 2024
• Source: The Second Hospital of Nanjing Medical University
• Contact: Sijing Wang, Master's student
• Phone: +8615664579913
• Email: 15664579913[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 20, 2027
• Est. primary completion date: July 20, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Gastroparesis
• Diabetic Gastropathy
• Digestive System Diseases
• Gastrointestinal Diseases
• Gastroparesis

Intervention

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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Gut Microbiome Sequencing	16S rRNA Sequencing	0 days,weeks 12 post-treatment
Secondary	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
Secondary	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
Secondary	Gastrointestinal Motility	Neurophysiological Method	0 days,weeks 12 post-treatment
Secondary	Heart Rate Variability	Neurophysiological Method	0 days,weeks 12 post-treatment
Secondary	Serum Metabolites	Liquid chromatography-mass spectrometry (LC-MS)	0 days,weeks 12 post-treatment