Proof-of-concept study of the efficacy of a microbiota-directed complementary food formulation (MDCF) for treating moderate acute malnutrition

• Published in: BMC public health 2020-02, Vol.20 (1), p.242-242, Article 242
• Main Authors: Mostafa, Ishita, Nahar, Naila Nurun, Islam, Md Munirul, Huq, Sayeeda, Mustafa, Mahfuz, Barratt, Michael, Gordon, Jeffrey I, Ahmed, Tahmeed
• Format: Article
• Language: English
• Subjects: Accounting; Acute Disease; Bangladesh; Biological markers; Biomarkers; Body weight gain; Care and treatment; Child Development; Child malnutrition; Childhood; Children; Children & youth; Consent; Diet; Dietary supplements; Enrollments; Female; Food; Food, Formulated; Gastrointestinal Microbiome; Global health; Health aspects; Humans; Infant; Infant Nutrition Disorders - diet therapy; Infant Nutrition Disorders - microbiology; Intervention; Intestinal microflora; Knowledge bases (artificial intelligence); Male; Malnutrition; Microbiota; Microbiota (Symbiotic organisms); Microbiota Directed Complementary Food (MDCF); Moderate acute malnutrition (MAM); Mortality; Nutrition research; Pathogenesis; Plasma; Proof of Concept Study; Randomized Controlled Trials as Topic; Ready to use Supplementary Food (RUSF); Repair; Rural Population; Severe acute malnutrition (SAM); Slums; Study Protocol; Undernutrition; Weight Gain; World health
• ISSN: 1471-2458; 1471-2458
• DOI: 10.1186/s12889-020-8330-8

Childhood undernutrition remains a significant global health challenge accounting for over half of all under 5 child mortality. Moderate acute malnutrition (MAM), which leads to wasting [weight-for-length z-scores (WLZ) between - 2 and - 3], affects 33 million children under 5 globally and more than 2 million in Bangladesh alone. We have previously reported that acute malnutrition in this population is associated with gut microbiota immaturity, and in a small, 1-month pre-proof-of-concept (POC) study demonstrated that a microbiota-directed complementary food formulation (MDCF-2) was able to repair this immaturity, promote weight gain and increase plasma biomarkers and mediators of healthy growth. Here we describe the design controlled feeding study that tests whether MDCF-2 exhibits superior efficacy (ponderal growth, host biomarkers of a biological state) than a conventional Ready-to-use Supplementary Food (RUSF) in children with MAM over intervention period of 3 months. Two separate cohorts of 12-18-month-old children will be enrolled: 124 with primary MAM, and 124 with MAM after having been treated for severe acute malnutrition (post-SAM MAM). We have established several field sites in an urban slum located in the Mirpur district of Dhaka, Bangladesh and at a rural site, Kurigram in the north of Bangladesh. The two groups of children receiving MDCF-2 and RUSF will be compared at baseline (pre-intervention), after 1 month, at the end of intervention (3 months), 1 month after cessation of intervention, and every 6 months thereafter for 4 years. This study will determine whether daily, controlled administration of MDCF-2 for 3 months provides superior improvements in weight gain, microbiota repair, and elevated levels of key plasma biomarkers/mediators of healthy growth compared to the control RUSF formulation. The pathogenesis of MAM is poorly defined and there are currently no WHO-approved treatments; results from the current study of children with primary MAM and post-SAM MAM will shed light on the effects of the gut microbiota on childhood growth/development and will provide a knowledge base that may help improve complementary feeding practices. The primary MAM and post-SAM MAM trials are registered in Clintrials.gov (NCT04015999 and NCT04015986, registered on July 11, 2019, retrospectively registered).