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Two-species probiotic product Lacticaseibacillus rhamnosus L34 and Lacticaseibacillus paracasei L45 for the reduction of body weight and metabolic risks in obese adults

Two-species probiotic product Lacticaseibacillus rhamnosus L34 and Lacticaseibacillus paracasei L45 for the reduction of body weight and metabolic risks in obese adults

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250109002
Enrollment
40
Registered
2025-01-09
Start date
2024-12-17
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Body weight and metabolic risk reduction in obese adults with probiotics Probiotics, Obesity, Gut microbiome

Interventions

Subjects take probiotic product 2 sachets per day for 12 weeks . Each sachet contains L. rhamnosus L34 1x 108 CFU and L45 1x 108 CFU. ,Subjects take placebo product 2 sachets per day for 12 weeks
Active Comparator Dietary Supplement,Active Comparator No treatment
Probiotics (L34andL45),Placebo

Sponsors

Program Management Unit Competitiveness(PMU-C)
Lead Sponsor
Greater Pharma Company Limited
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Informed consent Age at least 18 years old BMI between 25 and 35 kg/m2 Normal fasting blood glucose (FBG below 99 mg/dL) or impaired fasting glucose ( FBG between 100 and 125 mg/dL) and HbA1C less than or equal to 6.4%

Exclusion criteria

Exclusion criteria: Diabetes mellitus Thyroid disorders Kidney disease with eGFR below 30 ml/min/1.73m2 Chronic gastrointestinal disease with acute or chronic inflammation Use of antibiotic in 3 months Pregnancy or lactation Use of medication affecting body weight i.e. steroid within 3 months Use of weight-reduction medications within 3 months Adjusting dose of antihypertensive or lipid-lowering medications within 3 months Receiving any probiotics from other source within 2 weeks

Design outcomes

Primary

MeasureTime frame
body weight Immediate after finish intervention and 12 weeks after intervention weight measurement

Secondary

MeasureTime frame
Body composition Immediate after finish intervention and 12 weeks after intervention Body composition measured with bioelectrical impedance (BIA) method,Metabolic profiles Immediate after finish intervention and 12 weeks after intervention Oral glucose tolerance test (OGTT) which include fasting blood glucose and 2 hr after 75g of glucose intake, lipid profile, Insulin resistance score,,Stool profiles Immediate after finish intervention and 12 weeks after intervention stool probiotics and gut microbiome,Inflammatory markers Immediate after finish intervention and 12 weeks after intervention serum cytokine and endotoxin level

Countries

Thailand

Contacts

Public ContactNicha Somlaw

Faculty of Medicine, Chulalongkorn University

dr.nichasomlaw@gmail.com026494000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026