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Gut Microbiota-Targeted Fecal Microbiota Transplantation Therapy of Diabetic Gastrointestinal Autonomic Neuropathy

Gut Microbiota-Targeted Fecal Microbiota Transplantation Therapy of Diabetic Gastrointestinal Autonomic Neuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016597
Enrollment
Unknown
Registered
2018-06-11
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Gastrointestinal Autonomic Neuropathy

Interventions

Sponsors

Henan Province People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Type 1 or type 2 diabetes; 2. Aged 18-70 years old; 3. HbA1c<11%; 4. At least three months of history of gastrointestinal autonomic neuropathy (including diabetic gastroparesis, diabetic diarrhea, diabetic constipation, etc.) (symptoms are mostly early satiety, reflux, constipation, abdominal pain, nausea, vomiting, and diarrhea Wait).

Exclusion criteria

Exclusion criteria: 1. Persistent vomiting or suspected gastrointestinal obstruction; 2. Gastrectomy, fundoplication, colostomy and other digestive system surgery; 3. Receiving enteral nutrition or nasal feeding or other nutrient infusion; 4. Antibiotics used in the past 3 months for 3 days or more; 5. Thyroid dysfunction; 6. Combines connective tissue disease, multiple sclerosis and other systemic diseases that may affect gastric motility; 7. With severe organic disease, e.g. cancer, coronary heart disease, myocardial infarction and cerebral apoplexy; 8. With infectious disease, e.g. phthisis and Aids; 9. Patients with severe cardiovascular disease, lung, liver, kidney disease or eating disorders, or HIV patients; 10. Blood pressure more than 180/110mmHg, triglyceride more than 2.3mmol/L and cholesterol more than 6.2mmol/L; 11. With severe diabetes complications, e.g. leg ulcers, severe liver and kidney damage, severe neurological diseases and severe retinopathy; 12. Intemperance (drinking more than 5 times in one week and drinking more than 100g spirit, 250g rice wine or 5 bottles of beer); 13. With chronic persistant hepatitis, severe hepatic diseases, e.g. liver cirrhosis or cooccurence of positive HBsAg and abnormal hepatic transaminase; 14. Received drug therapy aim at the following diseases, e.g. cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, urocystitis or hyperthyreosis; 15. Pregnancy or planning to become pregnant; 16. Anemia: HbA1c less than 10g/dl; 17. Physical Disability or self-care disability or disability of recalling clearly and answering questions caused by any other reasons; 18. With obvious dyskinesia; 19. Without enough time taking part in this project.

Design outcomes

Primary

MeasureTime frame
Clinical symptom evaluation;Changes in GCSI;Gastric emptying rate;

Secondary

MeasureTime frame
Fast blood sugar concentration;HOMA-beta index;HbA1c;HOMA-IR index;CRP;

Countries

China

Contacts

Public ContactHuijuan Yuan

Henan Province People's Hospital

lmls3712@163.com+86 13513891997

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026