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To exploring probiotic intervention for diarrhoea in insulin-resistant people treated with metformin.

Probiotic intervention for diarrhoea in insulin-resistant people treated with metformin.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090457
Enrollment
Unknown
Registered
2024-09-30
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

diarrhoea

Interventions

Metformin treatment in the group of patients with insulin resistance and presence of diarrhoea:None
IRPL:Conventional treatment + oral placebo
IRPR:Conventional treatment + oral probiotics

Sponsors

Nanchang Reproductive Hospital (Affiliated Reproductive Hospital of Jiangxi University of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Experiment 1: 1. Women of childbearing age who are preparing for pregnancy in our hospital, who meet the diagnostic criteria for insulin resistance, and who are not diabetic. 2. Symptoms such as diarrhoea, increased frequency of stools, and watery stools with or without watery stools after administration of metformin for insulin resistance; 3. Patients without chronic diarrhoea, Crohn's disease, irritable abdominal syndrome and other diseases that can cause diarrhoea. No peptic ulcer, digestive system tumour, etc. after relevant examination; 4. No laxative, oral antibiotics, probiotics and other drugs that may cause changes in intestinal flora within one month. 5. No contraindications to oral metformin and no allergy to metformin and pill related ingredients. 6. Be aware of the treatment process and sign an informed consent form. Experiment 2: 1. Women of childbearing age who are preparing for pregnancy in our hospital, who meet the diagnostic criteria for insulin resistance, and who are not diabetic. 2. Symptoms such as diarrhoea, increased frequency of stools, and watery stools with or without watery stools after administration of metformin for insulin resistance; 3. Patients without chronic diarrhoea, Crohn's disease, irritable abdominal syndrome and other diseases that can cause diarrhoea. No peptic ulcer, digestive system tumour, etc. after relevant examination; 4. No laxative, oral antibiotics, probiotics and other drugs that may cause changes in intestinal flora within one month. 5. No contraindications to oral metformin and no allergy to metformin and pill related ingredients. 6. Be aware of the treatment process and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Experiment 1: 1. There is secondary diarrhoea due to a disease. 2. Those who are undergoing enema treatment. 3. History of treatment with oral antibiotics, antidiarrhoeal and laxative drugs within one month, and are using other drugs that may cause diarrhoea. 4. Have a serious active viral or bacterial infection that is not controlled by treatment. 5. Have any other serious or chronic illness that, in the opinion of the investigator, may interfere with the patient's treatment, follow-up, or evaluation. This includes any uncontrolled clinically significant neurological, psychiatric, immunomodulatory, metabolic, and infectious diseases. 6.A history of thromboembolic disease or a predisposition to thrombosis; 7. Patients who are not suitable for probiotic-assisted therapy after diagnosis and assessment by a clinician. Experiment 2: 1. There is secondary diarrhoea due to a disease; 2. Those who are undergoing enema treatment 3. History of treatment with oral antibiotics, antidiarrhoeal and laxative drugs within one month, and are using other drugs that may cause diarrhoea. 4. Have a serious active viral or bacterial infection that is not controlled by treatment; 5. Have any other serious or chronic illness that, in the opinion of the investigator, may interfere with the patient's treatment, follow-up, or evaluation. This includes any uncontrolled clinically significant neurological, psychiatric, immunomodulatory, metabolic, and infectious diseases; 6. A history of thromboembolic disease or a predisposition to thrombosis; 7. Patients who are not suitable for probiotic-assisted therapy after diagnosis and assessment by a clinician.

Design outcomes

Primary

MeasureTime frame
faecal microbiota;Hart Diarrhoea Score;HOMA-IR;routine blood test;blood biochemistry;

Countries

China

Contacts

Public ContactWeijun Chen

Department of Reproductive Medicine, Nanchang Reproductive Hospital (Affiliated Reproductive Hospital of Jiangxi University of Traditional Chinese Medicine)

cwj9998@163.com+86 138 0706 2856

Outcome results

None listed

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