NCT05185973

Effects of "For-Baby" Supplementation on Young Children's Physical Growth and Diarrhea Episodes

A Double Blinded Randomized Controlled, Community-based Trial in Rural Lao PDR to Determine the Positive Effects of "For Baby" Supplementation on Young Children's Physical Growth and a Reduction of Diarrhea Episodes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Lao Tropical and Public Health Institute · Other Government
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Not accepted

Summary

The LaoBiome Study is a community-based, randomized, placebo-controlled trial with two study arms conducted in Lao People's Democratic Republic. This study aims at providing evidence on impact of For-baby powder supplement on child physical growth, diarrheal incidence, environmental enteric dysfunction, adherence to the intervention, and neuro-behavioural development of: 1) daily administration of For-Baby powder supplements (Intervention Group) and 2) daily administration of micronutrient powder (Placebo-Controlled Group).

Detailed description

Probiotics are delivered as multiple micronutrient supplements in a powder package (For-Baby powder's sachet) and add into a single serving of clean water or breast milk and spoon feed the powder to the child 30 minutes before or after food consumption or add to semi-solid or mashed food such as mashed mango, banana and papaya, boiled pumpkin, and boiled egg after the food has been cooked and cooled sufficiently to be eaten (but within 30 minutes of preparation). Recent studies has shown that certain probiotics are extremely useful for the treatment of environmental enteropathy in malnourished children and has significant growth promoting effects. Nonetheless, new studies are needed to better understand the environmental enteropathy and its consequences. This community-based, randomized, placebo-controlled trial with two groups will be conducted in the community of Luangprabang province in the northern part of Lao PDR. The study team will enroll a total of 1,200 children, aged 6-23 months into the trial. The children will be randomly assigned one of two groups: 1) intervention group of daily For-Baby powder supplements and 2) control group of daily micronutrient powder supplements. After enrollment, the children will be under the observation for a total of 12 months (52 weeks). The monitored outcomes are the physical growth, diarrheal episodes, motor and intellectual development, gut microbiota and intestinal parasitic infections.

Conditions

• Children
• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	"For Baby "supplements provided as powder	One sachet daily
DIETARY_SUPPLEMENT	Micronutrient powder provided as powder	One sachet daily

Timeline

• Start date: 2022-03-20
• Primary completion: 2023-02-19
• Completion: 2023-09-30
• First posted: 2022-01-11
• Last updated: 2022-03-04