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NCT06340828Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
21 Mar 2024
Start date
20 Apr 2024
Primary completion date
20 Jul 2027
Lead sponsor
The Second Hospital of Nanjing Medical University
NCT number
NCT06340828

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 20 Apr 2024 to the primary completion date, 20 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Insulin dependent diabetes;
  • Active infections, antibiotics-using, inflammatory bowel disease, irritable bowel syndrome, or other severe gastrointestinal organic disease;
  • Thyroid disease, malignancies, severe cognitive impairment and mental disease;

Other

  • Severe diabetic complications;
  • Alcohol or substance abuse;
  • Pregnancy or lactation.

Who the study is looking for

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

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.