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Therapeutic effect of probiotic Li05 on obese patients:An exploratory trial

Therapeutic effect of probiotic Li05 on obese patients:An exploratory trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078934
Enrollment
Unknown
Registered
2023-12-21
Start date
2023-12-25
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Obesity

Interventions

Control:Oral administration of a placebo control
Li05:Oral administration of Pediococcus pentosaceus Li05

Sponsors

Shulan (Hangzhou) Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Participants of any gender, within the age of 18 and 45 year-old (2) Body mass index (BMI) ) = 28 kg/m2 ; (3) Male waist circumference = 90 cm, female waist circumference= 80 cm; (4) Participants who have not used any antibiotics, probiotics, other intestinal microecological modulator, or anti-obesity drugs in the recent one month before enrollment; (5) No history of chronic gastrointestinal diseases; (6) Willingness to participate in the study and sign the informed consent form for clinical trial.

Exclusion criteria

Exclusion criteria: (1) Pregnant women, breastfeeding women, or those planning to become pregnant within the next 6 months; (2) Liver dysfunction, indicated by alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels exceeding twice the normal value; (3) Renal insufficiency, defined as a glomerular filtration rate (GFR) below 90 mL/min; (4) Hypertension, and the use of more than 2 antihypertensive drugs, with blood pressure persistently higher than 160/100 mmHg; (5) Cardiac insufficiency; (6) Anemia or other hematological disorders; (7) Inflammation or immune system diseases; (8) Diabetes; (9) Thyroid dysfunction or lactose intolerance; (10) Current smokers; These are the basic exclusion criteria, and additional conditions will be evaluated by the doctor during the screening period.

Design outcomes

Primary

MeasureTime frame
Waist circumference;

Secondary

MeasureTime frame
Total Cholesterol;Weight;Body Mass Index;

Countries

China

Contacts

Public ContactGuoping Sheng

Shulan (Hangzhou) Hospital

guoping.sheng@shulan.com+86 159 9000 6685

Outcome results

None listed

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