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

February 17, 2022 updated by: Somphou SAYASONE, Lao Tropical and Public Health Institute

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children 6-23 months of age at enrollment,
  • Acceptance of weekly home visits for growth surveillance,
  • Planned residency within the study area for the duration of the study period (52 weeks),
  • Signed informed consent from a parent or legal caregiver.

Exclusion Criteria:

  • Weight-for-height z-score (WHZ) <-3SD with respect to World Health Organization 2006 standards;
  • Presence of bipedal edema;
  • Severe illness warranting hospital referral;
  • Congenital abnormalities potentially interfering with growth;
  • Chronic medical condition (e.g., malignancy) requiring frequent medical attention;
  • Known human immunodeficiency virus (HIV) infection of index child or child's mother;
  • Severe anemia (hemoglobin <70 g/L; based on testing at enrollment);
  • Currently consuming MNP supplements;
  • Current participation in any other clinical trial.

Criteria for discontinuation:

A subject can be discontinued from the study for the following reasons:

  • Withdraws from the study (this can happen anytime as participation is voluntary and there are no further obligations).
  • At the discretion of the principal investigator, if the participant is not compliant to the requirements of the protocol.
  • Discontinued subjects will not be replaced. If, for any reason, a subject is discontinued from the study before the end of the evaluations, the safety procedures planned (AEs monitoring) will be conducted. Data obtained prior to subject's withdrawal will be included in analysis. Data of withdrawn patients are fully anonymized once analysis is completed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "For-Baby powder" supplement
For-baby supplements provided as powder containing dry yeast powder, biovita mixed probiotics, synergy probiotics and other nutrients such as glucose, xylitol, chocolate powder, chocolate flavor powder, organic galactose oligosaccharide, chicory extract powder, vegetable Cream substitute, silicon dioxide, milk flavor powder, whole milk powder, zinc oxide, vitamin B12, vitamin B6, enzyme mixed preparation, vitamin C, organic alpha rice powder, folate 0.4mg, thiamine, leucin, isoleucin, valine, glutamine, and magnesium chloride.
Dietary supplement: "For Baby "supplements provided as powder
One sachet daily
Placebo Comparator: Micronutrient powder
Micronutrient powder containing containing glucose 236.3mg, xylitol 150mg, chocolate powder 600mg, chocolate flavor powder 45mg, organic galactose oligosaccharide 60mg, chicory extract powder 60mg, vegetable Cream substitute 135mg, silicon dioxide 45mg, milk flavor powder 30mg, whole milk powder 75mg, zinc oxide 11.2mg, vitamin B12 2.6mg, vitamin B6 2mg, enzyme mixed preparation 2mg, vitamin C 1mg, organic alpha rice powder 1mg, folate 0.4mg, thiamine 0.5mg, and maltodextrin 1,541mg.
Dietary supplement: Micronutrient powder provided as powder
One sachet daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in length and length-for-age Z-score
Time Frame: 52 weeks
Length of study children will be measured at the baseline, and follow-up surveys using seca baby's length measuring board.
52 weeks
Change in weight and weight-for-age Z-score,
Time Frame: 52 weeks
Weight of study children will be measured at the baseline, and follow-up surveys, using seca baby's digital scale.
52 weeks
Change in mid-upper circumference
Time Frame: 52 weeks
Mid- upper arm circumference will be measured the baseline, and follow-up surveys, using a mid upper arm circumference measuring tape.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of diarrheal episodes
Time Frame: 52 weeks
Report of diarrheal episodes will be recorded at the baseline and follow-up surveys
52 weeks
Number of children achieved the gross motor developmental milestones
Time Frame: 52 weeks
Gross motor developmental milestones as recommended by the World Health Organization include: sitting without support, crawling, standing with assistance, walking with assistance, standing alone, walking alone
52 weeks
Number of children with improved gut microbiota profile
Time Frame: 52 weeks
Gut microbiota will be assessed using microbiome analysis
52 weeks
Intestinal protozoa infection
Time Frame: 52 weeks
Intestinal protozoan infections will be assessed by a modified formalin-ethyl acetate concentration technique
52 weeks
Helminth parasitic infection
Time Frame: 52 weeks
Helminth parasitic infections will be assessed using duplicate Kato-Katz thick smears
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lao Tropical and Public Health Institute

Collaborators

Seoul National University
Institut Pasteur du Laos

Investigators

  • Study Director: Latsamy P Siengsounthone, MD, Lao Tropical and Public Health Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2022

Primary Completion (Anticipated)

February 19, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAO TROPICAL AND PUBLIC HEALTH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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