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A clinical study for intestinal microbiota transplantation in patients with type 1 diabetes mellitus

A clinical study for intestinal microbiota transplantation in patients with type 1 diabetes mellitus

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045789
Enrollment
Unknown
Registered
2021-04-25
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

Type 1 diabetes mellitus

Interventions

HMT(Human microbiota transplantation)group:Human microbiota transplantation
Control group:N/A

Sponsors

Shantou Longhu People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.According to the World Health Organization (who) diagnostic criteria for type 1 diabetes mellitus (T1DM) in 2019; 2.After intensive insulin therapy and stable blood glucose control, C-peptide was still lower than normal or lower limit of detection; 3.Patients over 18 years old should voluntarily participate in the trial, and the compliance is good; Patients younger than 18 years old need to obtain the informed consent of one or both guardians if necessary, with good compliance; 4.The patients over 18 years old obtain their own consent, the clamp test should be carried out; Patients younger than 18 years old were given clamp test with the consent of themselves and their guardians.

Exclusion criteria

Exclusion criteria: 1.Patients with acute and chronic infectious diseases, digestive tract diseases, cardiac insufficiency, liver and renal insufficiency; 2.Patients with gastrointestinal diseases that may affect drug absorption; 3.Pregnant and lactating women; 4.Allergic persons; 5.Patients treated with other hormones in the past three months; 6.Leukopenia or abnormal granulocytes; 7.Cardiovascular and cerebrovascular diseases within three months; 8.Those who participated in other clinical trials at the same time.

Design outcomes

Primary

MeasureTime frame
Blood glucose control;Intestinal mircobiota sequencing;

Secondary

MeasureTime frame
Insulin resistance;

Countries

China

Contacts

Public ContactHou Kaijian

Longhu People's Hospital

kaijianhou@126.com+86 13501400425

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026