Health Condition 1: M810- Age-related osteoporosis without current pathological fracture
Conditions
Interventions
Intervention1: Probiotics Blend: Probiotic Blend (Capsule/ Sachets)
[L. acidophilus 10^9 cfu
L. rhamnosus 10^9 cfu
B. coagulans 10^9 cfu
B. longum 10^9 cfu
Excipients q.s.]
and Calcium (500mg), Vitam
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Post-menopausal Women with a DEXA T-score of -2.5 or below.
Exclusion criteria
Exclusion criteria: 1. Any Osteoporotic patients receiving any treatment specific for osteoporosis (bisphosphonates, denosumab, or teriparatide, etc.) 2. Uncontrolled comorbidity (Diabetes, hypertension, Hypothyroidism). 3. Participants with histories of fracture and surgery, or severe injuries.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Bone Mineral Density (BMD) from baseline to 12 months, measured by DEXA scan at lumbar spine L1-L4, total hip, and femoral neck.Timepoint: Change in Bone Mineral Density (BMD) from baseline to 12 months, measured by DEXA scan at lumbar spine L1-L4, total hip, and femoral neck. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in bone turnover markers. 2. Changes in gut microbiota composition & diversity (alpha/beta diversity, relative abundance of specific taxa). 3. Changes in percentage of regulatory B cell population.Timepoint: 0 months, 3 months, 6 months & 12 months | — |
Countries
India
Contacts
Public ContactDr Rupesh K Srivastava
All India Institute of Medical Sciences New Delhi
Outcome results
None listed