Clinical trial NCT05185973: Effects of "For-Baby" Supplementation on Young Children's Physical Growth and Diarrhea Episodes
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children
Malnutrition
Keywords: Malnutrition
Nutrient supplementation
For-baby
Lao PDR
Lead sponsor: Lao Tropical and Public Health Institute
Sponsor class: OTHER_GOV
Collaborators: name: Institut Pasteur du Laos
name: Seoul National University
First posted: 2022-01-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The LaoBiome Study is a community-based double blinded randomized controlled trial. Approximately 1,200 infants and young children 6-23 months of age will be enrolled, and individually-randomized to one of two intervention groups of 600 children: 1) daily administration of For-Baby supplement (Intervention Group); 2) daily administration of micronutrient Placebo (Control Group). In both groups, children will remain under observation and receive their assigned supplements for a period of 12 months.
Primary purpose: TREATMENT

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-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.

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.

Primary outcomes:
measure: Change in length and length-for-age Z-score
timeFrame: 52 weeks
measure: Change in weight and weight-for-age Z-score,
timeFrame: 52 weeks
measure: Change in mid-upper circumference
timeFrame: 52 weeks
Secondary outcomes:
measure: Incidence of diarrheal episodes
timeFrame: 52 weeks
measure: Number of children achieved the gross motor developmental milestones
timeFrame: 52 weeks
measure: Number of children with improved gut microbiota profile
timeFrame: 52 weeks
measure: Intestinal protozoa infection
timeFrame: 52 weeks
measure: Helminth parasitic infection
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Lao Tropical and Public Health Institute
name: Latsamy P Siengsounthone, MD
role: STUDY_DIRECTOR
References:
citation: Schroder L, Kaiser S, Flemer B, Hamm J, Hinrichsen F, Bordoni D, Rosenstiel P, Sommer F. Nutritional Targeting of the Microbiome as Potential Therapy for Malnutrition and Chronic Inflammation. Nutrients. 2020 Oct 3;12(10):3032. doi: 10.3390/nu12103032.
citation: Maldonado NC, Chiaraviglio J, Bru E, De Chazal L, Santos V, Nader-Macias MEF. Effect of Milk Fermented with Lactic Acid Bacteria on Diarrheal Incidence, Growth Performance and Microbiological and Blood Profiles of Newborn Dairy Calves. Probiotics Antimicrob Proteins. 2018 Dec;10(4):668-676. doi: 10.1007/s12602-017-9308-4.
citation: Vadopalas L, Zokaityte E, Zavistanaviciute P, Gruzauskas R, Starkute V, Mockus E, Klementaviciute J, Ruzauskas M, Lele V, Cernauskas D, Klupsaite D, Dauksiene A, Sederevicius A, Badaras S, Bartkiene E. Supplement Based on Fermented Milk Permeate for Feeding Newborn Calves: Influence on Blood, Growth Performance, and Faecal Parameters, including Microbiota, Volatile Compounds, and Fatty and Organic Acid Profiles. Animals (Basel). 2021 Aug 30;11(9):2544. doi: 10.3390/ani11092544.
citation: Barkhidarian B, Roldos L, Iskandar MM, Saedisomeolia A, Kubow S. Probiotic Supplementation and Micronutrient Status in Healthy Subjects: A Systematic Review of Clinical Trials. Nutrients. 2021 Aug 28;13(9):3001. doi: 10.3390/nu13093001.
citation: Hajare ST. Effects of potential probiotic strains LBKV-3 on Immune Cells responses in Malnutrite children: a double-blind, randomized, Controlled trial. J Immunoassay Immunochem. 2021 Sep 3;42(5):453-466. doi: 10.1080/15321819.2021.1895217. Epub 2021 Mar 22.