Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06340828

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diabetic Gastroparesis Diabetic Gastroenteropathy Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus Diabetic Gastropathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location contact

Dafa Ding, Professor

CONTACT

[email protected]

+8615850514014

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Washing Microbiota Transplantation

Other

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.

Other names: Fecal Microbiota Transplantation

Primary outcomes

  1. Gastrointestinal Symptom Rating Scale

    Time frame: 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.

  2. Gut Microbiome Sequencing

    Time frame: 0 days，weeks 12 post-treatment

    16S rRNA Sequencing

Secondary outcomes

  1. Gastroparesis Cardinal Symptom Index

    Time frame: 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.

  2. Composite Autonomic Symptom Score 31

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

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

  3. Gastrointestinal Motility

    Time frame: 0 days，weeks 12 post-treatment

    Neurophysiological Method

  4. Heart Rate Variability

    Time frame: 0 days，weeks 12 post-treatment

    Neurophysiological Method

  5. Serum Metabolites

    Time frame: 0 days，weeks 12 post-treatment

    Liquid chromatography-mass spectrometry (LC-MS)

Study contacts

Contact information is provided by the study sponsor or research team.

Dafa Ding, Professor

CONTACT

[email protected]

+8615850514014

Sijing Wang, Master's student

CONTACT

[email protected]

+8615664579913

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2024
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.