Assessing Gut Bacteria Supplement in Underweight Infants

The Gates MRI recently announced it is beginning its phase 3 clinical trial, CONSTELLATION, to evaluate the effect of B infantis as a dietary supplement in underweight infants. The study was looking to enroll its first patient in Pakistan this summer.

The trial is a randomized, double-blind, placebo-controlled trial with 396 underweight infants between 1 and 4 months of age who were hospitalized for acute nonsurgical illness. The Infants will be divided into two cohorts with half of them receiving B infantis probiotic supplement, Bi-26, daily for 28 days, and the other half will receive a placebo daily for 28 days. Infants will be followed in the study for approximately 3 months.

Gates MRI has reported it has a number of goals for the trial including:

• Evaluating whether supplementation with the B infantis probiotic supplement Bi-26TM can promote weight gain in underweight infants
• Assessing safety of Bi-26
• Assessing the impact of Bi-26 on hospital readmission rates
• Describing the fecal microbiome composition and gut microbiome and systemic biomarkers

B infantis is a type of lactic acid bacteria found in the oral cavity and gastrointestinal tract. It’s commonly found in the microbiome of breast-fed infants younger than 6 months of age in low-income and middle-income countries (LMICs), according to Gates MRI. B infantis has the capacity to consume complex carbohydrates found in human milk, which helps its ability to colonize the infant gut and outcompete pathogenic bacteria. Babies in LMICs who are underweight often have lower amounts of B infantis in their gut compared to healthy babies.

In undernourished infants, it is thought that an imbalance in the gut microbiome, characterized by a low level of bifidobacteria and an overrepresentation of pathogenic bacteria, may result in an inability to absorb sufficient nutrients.