RecruitingNot Applicable

Washed Microbiota Transplantation for Diabetic Gastroparesis

China46 participantsStarted 2024-04-01

Plain-language summary

This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosed with diabetes for over 1 year;
✓. Accompanied by symptoms such as abdominal bloating, early satiety, persisting for at least 3 months, with a GCSI Total Score greater than/equal to 2.3;
✓. Objective evidence of delayed gastric emptying within the past 3 months, including but not limited to scintigraphic gastric emptying or gastric ultrasound;
✓. Upper gastrointestinal obstructive lesions were ruled out by imaging or endoscopic examination within the past 3 months;
✓. Males and nonpregnant, non-breastfeeding females who are aged more than 18 years and sign the informed consent form;
✓. The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.

Exclusion criteria

✕. Have any upper gastrointestinal pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial;
✕. Have a prior history of gastric surgery, including but not limited to gastric bypass, gastrectomy, gastric banding, pyloroplasty, fundoplication, or vagotomy in past 1 year;
✕. Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes;
✕. Have been using medications affecting gastrointestinal motility, such as GLP-1 agonists;
✕. Have contraindications for intestinal tubing;
✕. Have a history of medication that regulate intestinal microbiome in last 48 hours;
✕. Have serious diabetic complications need immediately be dealt, such as diabetic ketoacidosis
✕. Have poor lung function and those deemed by the investigator to be affected by the study treatment, such as during COPD exacerbations;

What they're measuring

The proportion of DGP with symptom relief after the procedure.

Timeframe: Four-week post-WMT

Trial details

NCT IDNCT06340217

SponsorThe Second Hospital of Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

Faming Zhang, PhD

086-025-58509883 fzhang@njmu.edu.cn

View on ClinicalTrials.gov More Diabetic Gastroparesis trials