LaoBiome Project

Title: Effects of “For Baby” supplementation on young children’s physical growth and a reduction of diarrheal episodes: A double blinded randomized controlled, community-based trial in rural Lao PDR

Principal Investigator
Dr. Latsamy Seingsounthone, Lao Tropical and Public Health Institute (Lao TPHI)

Co-investigators and other persons involved
Somphou Sayasone, Lao TPHI
Paul Brey, IPL
Won Jae Lee, Seoul National University, South Korea
Mrs. Somsanith Chonephetsarath, Coordinator, IPL
Members of Parasitology Lab, IPL

Period: 2022-2023
Study area:
Luang Prabang province

Finance and administration:
Dr. Antoine des GRAVIERS and Ms. Phouvanhnamalee VILAYSOUK

Background

Children living in communities with poor sanitation are at increased risk of developing environmental enteropathy (EE), a condition marked by significant changes in gut structure and function, as well as intestinal inflammation and a lack of overt diarrhea. Thus, EE may play an important role in malnutrition and impaired infant development [1].

In settings, where several micronutrient deficiencies often co-exist multiple micronutrient powders (MNP) have been a preferred approach to improve young children’s nutrition and health [2,3]. MNP were originally designed for home-fortification of complementary foods to prevent deficiencies of multiple micronutrients namely iron, Zinc, Vit A and other 13 minerals and vitamins were also included. Since 2014, 50 countries were implementing large-scale programs to distribute MNP [4,5]. In Lao PDR, MNP was introduced as supplementation program in 34 districts of 7 provinces in 2017, aiming to promote home-fortification of complementary foods to prevent deficiencies of multiple micronutrients that exists largely among malnourished children. While there is consistent evidence on the beneficial impact of MNP on iron status and anemia, the impact of MNP on morbidity, developmental, and growth outcomes, has been inconsistent [4,6]. MNP use has also been associated with altered gut microbiota, intestinal inflammation, and an increased risk of diarrhea in some studies, possibly related to the provision of supplemental iron in MNP (10-12.5 mg/d) and modified by individuals’ underlying iron status [7,8].

Recently, modulation of microbiome by therapeutic diet and supplementation has been shown to be effective in animal model, as well as in human [9]. This new therapeutic study to treat environmental enteropathy (EE) has been nominated as “the breakthrough of the year 2019” for nutritional therapy. Studies demonstrated that single species of Lactobacillus plantarum is sufficient to induce growth promotion in different animal models from Drosophila to mice [9,10].

The long history of safe use of various probiotics in fermented foods and their presence in the normal intestinal and urogenital microbiota of humans has brought probiotic therapeutics to the forefront of scientific research [11,12]. Recent research has shown that certain probiotics are extremely useful for the treatment of EE in malnourished children and has significant growth promoting effects [1,13,14]. However, new studies are needed to better understand EE and its consequences.

This double blinded randomized controlled trial is designed to provide empirical evidence to inform global guidelines and country policies for delivering “For-Baby” supplement to young children which could provide the maximal beneficial impact on gut health and nutritional status of young children.

Objective

The aim of this trial is to determine the positive effects of “For-Baby” supplementation on physical growth and a reduction of diarrheal episodes in young children aged 6–23 month-old at inclusion, after a year of supplementation in Lao PDR.

Methodology

The LaoBiome Study is a community-based double blinded randomized controlled trial. Approximately 1,200 infants and young children 6-23 months of age will be enrolled, and individually-randomized to one of two intervention groups of 600 children: 1) daily administration of “For-Baby” supplements (Intervention Group); 2) daily administration of micronutrient Placebo (Control Group). We use micronutrient placebo as it is currently advised in national nutrition policy, however, for the programmatic point of view, iron taste in MNP reduces compliance, and therefore we exclude the iron from MMNP in this LaoBiome study. In both groups, children will remain under observation and receive their assigned supplements for a period of 12 months (52-weeks). Stool samples will be collected from the study participants at three-time points: month 0 (base line data: before taking the supplement or placebo), month 6, and month 12.

Progress

IPL Parasitology Lab takes responsibility for stool sample collection and stool examination by formalin-ethyl acetate concentration technique (FECT) and a calprotectin rapid diagnostic test (RDT) kit with collaboration with Lao TPHI team. Currently, the base line survey (month 0) was conducted from March-July 2023 (a total of four field surveys) and month 6 survey (only once) was conducted by the IPL Parasitology team. To investigate inflammation of intestine, calprotectin is examined by calprotectin RDT on site whereas, to investigate parasite infection status, FECT was performed at IPL. The data will be published after the analyses will be completed.

Financial support

This project is supported by ILDONG Pharmaceutical Co., Ltd. and Saeloun Bio Co., Ltd.

References

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