Collection and handling of biospecimens obtained from participants in the randomized controlled clinical study of the efficacy of MDCF-2
malnutrition
MALNUTRITION
The human study entitled ‘Community-based clinical trial with microbiota-directed complementary foods (MDCFs) made of locally available food ingredients for the management of children with primary moderate acute malnutrition (MAM)’ was approved by the Ethical Review Committee at the icddr,b (protocol PR-18073; ClinicalTrials.gov: A total of 124 male and female children with MAM (WLZ, −2 to −3) between 12- and 18-months old who satisfied the inclusion criteria were enrolled, with 62 children randomly assigned to each treatment group using the permuted block randomization method. Children in each treatment group were fed their assigned dietary supplement (MDCF-2 or RUSF) twice daily at a study centre for the first month, once daily at a study centre and once daily at home for the second month, and twice daily at home for the third month. Mothers were otherwise encouraged to practice their customary breast-feeding and complementary-feeding practices. At the end of the intervention period, children returned to their normal feeding routine with continued intensive monitoring for one additional month. Fifty-nine participants in each treatment group completed the 3-month intervention and 1-month post-treatment follow-upTo minimize the risk of degradation of faecal DNA/RNA, faecal samples were collected within 20 min of their production and immediately transferred to liquid-nitrogen-charged vapour shippers for transport to a −80 °C freezer at the study centre. The samples were shipped to Washington University on dry ice where they were stored at −80 °C in a dedicated repository with approval from the Washington University Human Research Protection Office.