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The role of gut microbiota and bile acids in type 2 diabetic constipation: A single-center, prospective, cohort study

The role of gut microbiota and bile acids in type 2 diabetic constipation: A single-center, prospective, cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105681
Enrollment
Unknown
Registered
2025-07-09
Start date
2023-10-01
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Diabetes

Interventions

Diabetic constipation group:None
Control group:None

Sponsors

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age over 18 years old and under 75 years old. 2. No use of antibiotics, probiotics, enemas, or drugs affecting bile acid metabolism, such as bile acid sequestrants, within the last month. 3. T2DM constipation patients must meet conditions 1 and 2, and also meet the diagnostic criteria for diabetes in the 2020 "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus" and the definition of constipation in the 2019 "Chinese Expert Consensus on Chronic Constipation". 4. Constipation occurred after the onset of diabetes. 5. Functional constipation patients must meet conditions 1 and 2 and also meet the diagnostic criteria for functional constipation in Rome IV. 6. Healthy control group must meet conditions 1 and 2, have no history of chronic diseases or abdominal surgeries, and have a healthy lifestyle and dietary habits.

Exclusion criteria

Exclusion criteria: 1. Patients with type 1 diabetes and those with fasting blood glucose > 16.7 mmol/L that is uncontrolled. 2. Patients with constipation before the onset of diabetes. 3. Patients with previous organic intestinal lesions (such as intestinal tuberculosis, colorectal tumors, intestinal stenosis or obstruction). 4. Patients with previous surgical history of the gastrointestinal tract, liver and gallbladder, pelvis, or spine. 5. Patients with severe cardiovascular and cerebrovascular diseases, other systemic organic diseases, such as malignant tumors, etc.

Design outcomes

Primary

MeasureTime frame
Gut microbiota composition and diversity assessment;

Secondary

MeasureTime frame
Composition of bile acids;

Countries

China

Contacts

Public ContactLiuqin Jiang

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

jiangliuqin@163.com+86 25 68303472

Outcome results

None listed

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