Clinical Trials Logo

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05185973
Study type Interventional
Source Lao Tropical and Public Health Institute
Contact Somphou Sayasone, PhD
Phone +8562055679603
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 1, 2022
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04488718 - ESj- Powder Complete T&A Study N/A
Not yet recruiting NCT04067284 - Homemade Yogurt Supplementation to Prevent Stunting N/A
Completed NCT02858011 - The Effect of a Cash Transfer Program and Preventive Nutrition Packages on Household Welfare and Child Nutritional Status in Mali Phase 4
Completed NCT02988180 - Intervention on Development and Growth at Children in Poverty N/A
Completed NCT01817634 - ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia N/A
Active, not recruiting NCT03886467 - Strategies to Increase Milk Consumption by Young Nepali Children N/A
Terminated NCT04133766 - Community-based Nutrition Program Effectiveness Evaluation in Afghanistan N/A
Active, not recruiting NCT04257383 - The Sugira Muryango PLAY Collaborative N/A
Completed NCT02427945 - Leveraging an Existing Large-scale Safe Water Program to Deliver Nutrition Messages at a Low Marginal Cost N/A
Completed NCT02071563 - Effectiveness and Cost-Effectiveness of Four Formulations of Food Supplements for the Prevention of Wasting and Stunting in Burkina Faso N/A
Completed NCT01497236 - Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda N/A
Completed NCT02914002 - Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings N/A
Completed NCT02257437 - Acceptability of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia N/A
Completed NCT02258802 - Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings N/A
Completed NCT03751475 - Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Democratic Republic of Congo N/A
Completed NCT01873196 - Food Aid Quality Review: Feasibility and Acceptability Study of Corn Soy Blend and Fortified Vegetable Oil in Malawi N/A
Not yet recruiting NCT04764695 - Nutritional Intervention in Acute Lymphoblastic Leukemia N/A
Not yet recruiting NCT05181293 - Mobile Gaming App to Improve Child Nutrition in Nigeria N/A
Completed NCT02616289 - Emollient Therapy for Severe Acute Malnutrition N/A
Recruiting NCT03641001 - Nutrition Intervention Integrated With Food Voucher to Improve Child Growth and Feeding Practices N/A