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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

More The Second Hospital of Nanjing Medical University trials in China

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