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Clinical Research on GLP-1 Engineered Bacteria for the Treatment of Metabolic-Related Diseases

Clinical Research on GLP-1 Engineered Bacteria for the Treatment of Metabolic-Related Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104877
Enrollment
Unknown
Registered
2025-06-25
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Obesity

Interventions

Placebo group:Oral engineering Clostridium butyricum preparation (the same composition as the bacterium, no GLP-1)
Live bacteria intervention group:Oral engineered Clostridium butyricum GLP-1 agent (1×10^9 CFU/day)

Sponsors

Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age and BMI: 18-65 years old, BMI >=30 kg/m^2 (obesity) or BMI>=27 kg/m62 with at least one obesity-related complication (such as hypertension, type 2 diabetes, non-alcoholic fatty liver disease). 2. Metabolic stability: fasting blood glucose =3.0.

Exclusion criteria

Exclusion criteria: 1. Comorbid diseases: severe liver and kidney insufficiency (ALT/AST> 3 times the upper limit, eGFR<30 mL/min/1.73m^2), inflammatory bowel disease, immunodeficiency or active tumor. 2. Drug interference: long-term use of glucocorticoids, immunosuppressants, or drugs that affect gastrointestinal motility (such as orlistat). 3. Pregnancy and breastfeeding: Women of childbearing age need to take effective contraceptive measures and have a negative pregnancy test. 4. History of allergies: allergy to E. coli or engineered bacterial carrier components

Design outcomes

Primary

MeasureTime frame
Stool high-throughput sequencing;Fecal GLP-1 content;

Secondary

MeasureTime frame
Biochemical indicators;Metabolic Parameters;

Countries

China

Contacts

Public ContactChen Weijun

Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine

112307068@qq.com+86 138 0706 2856

Outcome results

None listed

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