A phase 3 randomized double-blind placebo-controlled study to evaluate the effect of BI-2 supplementation versus placebo on weight gain in underweight infants

This project aims to evaluate the change in weight (standardized for age) of infants who are administered Bi-26, a strain of Bifidobacterium Longum, B Infatis.

As per the World Health Organization (WHO), infant undernutrition can lead to impaired growth, immune and metabolic dysfunction, increased risk of infection, altered development of the central nervous system (CNS) and other abnormalities. In 2022, the WHO reported that undernutrition accounts for a global mortality of more than 3 million children every year.

Underweight infants hospitalized with an acute illness are particularly at high risk of death. Supplementation of B.infantis strain EVC 001 has resulted in reduction of pro-inflammatory cytokines, and an increase in WAZ score in previous trials in the US and Bangladesh. In LMIC, Bi-26 strain could potentially be used as a dietary supplement in underweight infants, if safety and efficacy findings of previous trials are confirmed.

The project will be implemented by Ifakara Health Institute, focusing on evaluating the weight variation in infants receiving Bi-26. The objectives include estimating the treatment response over time, evaluating the proportion of infants achieving a specified change in WAZ, assessing the re-hospitalization rate, examining the safety of Bi-26 supplementation until the End of Study (EoS) at the Day 90 visit, and measuring the engraftment of B. infantis in participants (presence of B. infantis in stool on Days 1, 28, 56, and 90).

Participants enrolled in the study will include male and female infants aged between 30 days and 120 days at the time of enrollment (study Day 1). 

Collaborators in the project will include Bagamoyo District Hospital, Chalinze, Tumbi, and field workers/Community Health Workers (CHW), including community advisory board and Bagamoyo District authorities.

The project will be under the leadership of Ifakara scientist, Dr. Omar Lwemo, the local Principal Investigator.