BACKGROUND:
Childhood
undernutrition is a major
public health concern that
needs special
attention to achieve 2025 global
nutrition targets. Moderate acute
malnutrition (MAM), manifest as wasting (low weight-for-height),
affects 33 million
children under 5, yet there are currently no global guidelines for its
treatment. We recently performed a randomized-controlled
clinical study of a
microbiota-directed complementary
food formulation (MDCF-2) in 12-18-month-old Bangladeshi
children with MAM. The results revealed that MDCF-2, freshly prepared each day, produced a significantly greater improvement in ponderal
growth than a standard ready-to-use supplementary
food (RUSF), an effect that is associated with repair of the disrupted gut
microbial community development that occurs in
children with MAM. To test the generalizability of these results in acutely malnourished
children at other sites, there is a pressing need for a packaged, shelf-stable, organoleptically-acceptable formulation that is bioequivalent to MDCF-2. This
report describes the protocol for a
clinical study to evaluate candidate formulations designed to meet these criteria.
METHODS:
A randomized
single-blind study will be conducted in 8-12-month-old Bangladeshi
children with MAM to compare the
efficacy of alternative shelf-stable MDCF prototypes versus the current MDCF-2 formulation that is produced fresh each day. V4-16S
rDNA amplicon and shotgun sequencing datasets
will be generated from faecal
DNA samples collected from each
child enrolled in each group prior to, during, and
after treatment to determine the abundances of MDCF-2-responsive bacterial taxa.
Efficacy will be assessed by quantifying the change in representation of MDCF-2-responsive gut bacterial taxa after 4-weeks of
treatment with freshly prepared MDCF-2 compared to their changes in abundance
after treatment with the prototype MDCFs. Equivalence
will be defined as the absence of a statistically significant difference, after 4-weeks of
treatment, in the representation of faecal bacterial taxa associated with the response to MDCF-2 in participants receiving a test MDCF.
DISCUSSION:
This trial aims to establish acceptability and equivalence with
respect to
microbiota repair, of scalable, shelf-stable formulations of MDCF-2 in 8-12-month-old Bangladeshi
children with moderate acute
malnutrition. TRIAL REGISTRATION ClinicalTrials.gov (NCT05094024). The trial has been registered before starting enrolment on 23 October 2021.