Effects of "For-Baby" Supplementation on Young Children's Physical Growth and Diarrhea Episodes (LaoBiome)
Children, Malnutrition
About this trial
This is an interventional treatment trial for Children focused on measuring Malnutrition, Nutrient supplementation, For-baby, Lao PDR
Eligibility Criteria
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 Data of withdrawn patients are fully anonymized once analysis is completed.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
"For-Baby powder" supplement
Micronutrient powder
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.
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.