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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Second Hospital of Nanjing Medical University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Clinical diagnosis of type 2 diabetes and diabetic gastrointestinal motility disorder.

Glycated hemoglobin (HbA1c) < 11.0%.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Washing Microbiota Transplantation

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Washing Microbiota Transplantation (WMT) groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gastrointestinal Symptom Rating Scale

Questionnaires,the minimum score is 0,and maximum is 45, and higher scores mean a worse outcome.

Time frame
0 days,weeks 1, 4, and 12 post-treatment
2

Gut Microbiome Sequencing

16S rRNA Sequencing

Time frame
0 days,weeks 12 post-treatment

Secondary outcomes

1

Gastroparesis Cardinal Symptom Index

Questionnaires,the minimum score is 0,and maximum is 45, and higher scores mean a worse outcome.

Time frame
0 days,weeks 1, 4, and 12 post-treatment
2

Composite Autonomic Symptom Score 31

Questionnaires,the minimum score is 0,and maximum is 75, and higher scores mean a worse outcome.

Time frame
0 days,weeks 1, 4, and 12 post-treatment
3

Gastrointestinal Motility

Neurophysiological Method

Time frame
0 days,weeks 12 post-treatment
4

Heart Rate Variability

Neurophysiological Method

Time frame
0 days,weeks 12 post-treatment

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: