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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06340828
Other study ID # 2023-KY-186-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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