Impact of supplementation of a package of iron folic acid (IFA) with probiotics on hemoglobin levels in elderly with mild to moderate anemia: Protocol for a double blind randomized controlled trial (PRobiotics in Anemia Trial for Healthy Ageing Management - PRATHAM)

Abstract Background Anemia is a major health concern of the elderly with iron deficiency anemia and anemia of chronic diseases being the two major causes of anemia. Probiotics help in anemia correction in several ways. It increases oral iron absorption by directly modulating immunity, eliciting an anti-inflammatory response, reducing ferric iron to bioavailable ferrous iron, and enhancing iron uptake by enterocytes. This is especially relevant in old age, as aging is associated with age-related gradual attrition of protective organisms in gut microbiota. As there are no studies on the efficacy of probiotics supplementation in anemia management in the elderly, a study has been planned to determine the impact of supplementation of a therapeutic package of Iron and Folic Acid (IFA) and probiotics on hemoglobin levels in elderly with mild to moderate anemia in comparison to IFA only. Methods This community-based randomized controlled trial will be conducted in the Kalyani Municipality area of Nadia district, West Bengal, India. Individuals aged 60 years and above with mild to moderate anemia will be randomized into the intervention (IFA and probiotics) and control group (IFA and placebo gelatin capsules containing ORS). The medications will be self-administered. The calculated sample size is 100 in each arm. Block randomization will be done. Participants will be followed up weekly for 12 weeks. Discussion Changes in hemoglobin, ferritin, hepcidin, C-reactive protein (CRP), composition, and diversity of the gut microbiome from baseline to 12 weeks in both groups will be assessed. Ethics and dissemination: Ethical approval was obtained from the Institutional Ethics Committee of AIIMS Kalyani (Ref. No: IEC /AIIMS / Kalyani / Meeting/ 2023 / 020). Trial Registration Number: The trial was registered in Clinical Trials Registry-India (CTRI) (CTRI/2023/09/057830) on 19.09.2023 Protocol version: Version: 1.0