Status:
UNKNOWN
Effects of "For-Baby" Supplementation on Young Children's Physical Growth and Diarrhea Episodes
Lead Sponsor:
Lao Tropical and Public Health Institute
Collaborating Sponsors:
Institut Pasteur du Laos
Seoul National University
Conditions:
Children
Malnutrition
Eligibility:
All Genders
6-23 years
Phase:
NA
Brief 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-...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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 Data of withdrawn patients are fully anonymized once analysis is completed.
Key Trial Info
Start Date :
March 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05185973
Start Date
March 20 2022
End Date
September 30 2023
Last Update
March 4 2022
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