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Efficacy and safety of functional bacteria of intestinal microorganisms in obese patients with type 2 diabetes

Efficacy and safety of functional bacteria of intestinal microorganisms in obese patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064120
Enrollment
Unknown
Registered
2022-09-27
Start date
2022-10-10
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Type 2 diabetes

Interventions

Intervention group:Powder (including 10 ^ 10 CFU/bag of intestinal functional bacteria preparation), oral twice a day (after breakfast and dinner), one bag each time
control group:placebo

Sponsors

The First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation in this clinical trial; 2. Aged 18-75 years; 3. BMI >= 24 kg/m2, waist circumference >= 80 cm (female), waist circumference >= 90 cm (male); 4. Type 2 diabetes that meets the diagnostic criteria of diabetes in the Chinese Medical Association's 2020 edition of China's guidelines for the prevention and treatment of type 2 diabetes, and does not use any hypoglycemic drugs in the past three months, only diet and exercise control blood sugar, and HbA1c < 7.5%.

Exclusion criteria

Exclusion criteria: 1. Oral drugs such as antibiotics, glucocorticoids, GLP-1 and GLP-1 analogues in recent 3 months; Subjects who received intramuscular or intravenous systemic administration, non gastrointestinal administration or intra-articular administration in the last 3 months; 2. Those who have taken yogurt, probiotics and probiotics in recent 3 months; 3. Have a history of abuse of psychoactive substances; 4. Severe hepatic and renal insufficiency; 5. Chronic gastrointestinal diseases, gastrointestinal diseases that cause various acute and chronic diarrhea or severe constipation; 6. Smoking history > 10 years; 7. Daily consumption of alcohol > 30 g; 8. Serious diseases such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, cirrhosis, kidney disease, infection, and malignant tumor; 9. Pregnant or lactating women, or planned pregnancy in the next 6 months; 10. Nervous system diseases: such as Alzheimer's disease, stroke, Parkinson's disease; 11. Participate in other clinical trials in the past 6 months; 12. Mental diseases: such as schizophrenia, bipolar disorder; 13. Those who have undergone digestive tract surgery within one year or other non digestive tract surgery within half a year.

Design outcomes

Primary

MeasureTime frame
Glucose tolerance;obesity improvement;intestinal symbiotic bacteria homeostasis.;

Secondary

MeasureTime frame
blood pressure;blood lipid;uric acid;hormone level;visceral fat;vascular endothelial function;

Countries

China

Contacts

Public ContactWeng Jianping
wengjp@ustc.edu.cn13903000303

Outcome results

None listed

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