None listed
Conditions
Interventions
Intervention1: Intervention (Torani- Fermented rice water) group: The intervention (Torani) group participants shall consume 350 ml of Torani daily along with their normal dietary intake (no other res
Sponsors
Bill and Melinda Gates Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-pregnant participants: women aged >18 years to 45 years, staying in the locality and expected to stay for next 6-8 months; access to phone for contact; not suffering from any major systemic disease, ambulatory 2. Pregnant participants: pregnant women aged >18 years to 45 years, first trimester pregnancy, no high risk factors or bad obstetric history, staying in the locality and expected to stay for next 6-8 months; access to phone for contact; not suffering from any major systemic disease, ambulatory
Exclusion criteria
Exclusion criteria: 1. Refusal for consent, inability to follow the schedule, unwilling to accept or not feasible to consume the fermented rice-water as per schedule 2. Taking/requiring steroid or antibiotics regularly or for long period for medical reasons 3. Known case of immunocompromised status 4. Undergone major intestinal surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Documentation of the microbiota and nutritional profile of the fermented rice-water (Pakhala/Torani) and time-course changes 2. Documentation of optimal intake dose of the fermented rice-water (Torani) for effect on the gut microbiota 3. Documentation of the process of fermented rice-water preparation in laboratory setting for standardization and stability 4. Documentation of the impact of the fermented-rice (Torani) intake on nutrition, gut and vaginal microbiota, gut microbiome, and inflammatory markers in reproductive-age womenTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Trend of change in the microbiota and nutritional parametersTimepoint: 1, 2, 4 months | — |
Countries
India
Contacts
Public ContactManoja Kumar Das
The INCLEN Trust International
Outcome results
None listed