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The clinical study on the treatment of fecal microbiota transplantation for refractory diabetes mellitus

The clinical study on the treatment of fecal microbiota transplantation for refractory diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014569
Enrollment
Unknown
Registered
2018-01-22
Start date
2018-01-23
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

Diabetes Mellitus

Interventions

trial group:fecal microbiota transplantation
control group:conventional therapy

Sponsors

First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged from 18 to 75 years. 2.Diagnosis of type 1 diabetes whose glycemia is poorly controlled with insulin treatment for more than 6 months.Manifested as follows:FPG fluctuation >5.55mmol/L;2h-PG fluctuation = 11.1mmol/L;urinary ketone body positive repeatedly;hypoglycaemic events occur unpredictably.3.Diagnosis of type 2 diabetes whose glycemia is poorly controlled with insulin dose over 0.8U/kg.d and (or)combining oral antidiabetic drugs more than 6 months. 4.Patients volunteered to participate in and sign the consent form.

Exclusion criteria

Exclusion criteria: 1.severe diabetic complications,such as severe retinopathy,ulcer,etc;2.had gastric or intestinal surgery which caused changes in the anatomy of the gastrointestinal tract;3.had other autoimmune diseases,such as inflammatory bowel disease,systemic lupus erythematosus,etc;4.patients with pregnancy or having a fertility plan;5.patients with drugs or other substance abusers;6.Alcoholics:Subjects consuming> 2 servings of alcoholic beverages or> 14 servings per day (one Alcoholic beverages are defined as 150ml of wine, or 350ml of beer, or 50ml The standard degree of 80% (40 degrees) of spirits);7.Have a history of severe allergy; 8.patients with severe heart,liver,renal insufficiency,severe cerebrovascular and lung disease;9.reduce weight by any drugs or surgery;10.participants who taking antibiotics within 3 months or probiotics within 4 weeks;11.patients can not cooperate with clinical researchers for other reasons.

Design outcomes

Primary

MeasureTime frame
blood glucose level;HbA1C;Serum c-peptide levels;Serum insulin level;Gut Microbiota;

Secondary

MeasureTime frame
CRP;IL-6;

Countries

China

Contacts

Public ContactJixiong Xu

First Affiliated Hospital of Nanchang University?

xujixiong@163.com+86 13307086069

Outcome results

None listed

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