PRobiotics in Anemia Trial for Healthy Aging Management
- Conditions
- Health Condition 1: E611- Iron deficiency
- Registration Number
- CTRI/2023/09/057830
- Lead Sponsor
- Department of Health Research, Ministry of Health and Family Welfare, Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Individuals aged 60 years and above, a permanent resident of the area, are expected to stay in the area for 6 months following enrolment, gives consent to participate in the study, screened to have mild to moderate anemia and have not taken any probiotic or antibiotics in the past 30 days prior to enrolment will be included in the present study
Individuals with no anemia (Male: Hemoglobin >13gm/dl and Female: Hemoglobin >12gm/dl), with severe anemia (Hemoglobin <8gm/dl), known history of gastrointestinal & metabolic disorders, chronic renal failure, received blood donations in last 6 months and regularly consuming nutritional supplements (Iron, folic acid, Vitamin B12, Vitamin D and other multivitamins and minerals), diagnosed cases of pancreatitis, hypersensitivity to any ingredient in the supplement and those who participated in any other clinical trial in the preceding 30 days will be excluded from the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the impact of supplementation of a therapeutic package of Iron & Folic Acid & probiotics on hemoglobin level in elderly with mild to moderate anemia in comparison to IFA onlyTimepoint: From baseline to 12 weeks of intervention
- Secondary Outcome Measures
Name Time Method To compare the change in composition & diversity of the gut microbiome between two groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on CRP level in both the groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on ferritin concentration in both the groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on hepcidin level in both the groupsTimepoint: From baseline to 12 weeks of intervention;To determine the impact on incidence of acute infections in both the groupsTimepoint: From baseline to 12 weeks of intervention