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

Primary Purpose

Children, Malnutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"For Baby "supplements provided as powder
Micronutrient powder provided as powder
Sponsored by
Lao Tropical and Public Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children focused on measuring Malnutrition, Nutrient supplementation, For-baby, Lao PDR

Eligibility Criteria

6 Months - 23 Months (Child)All SexesDoes not accept healthy volunteers

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 Data of withdrawn patients are fully anonymized once analysis is completed.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

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    "For-Baby powder" supplement

    Micronutrient powder

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Incidence of diarrheal episodes
    Report of diarrheal episodes will be recorded at the baseline and follow-up surveys
    Number of children achieved the gross motor developmental milestones
    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
    Number of children with improved gut microbiota profile
    Gut microbiota will be assessed using microbiome analysis
    Intestinal protozoa infection
    Intestinal protozoan infections will be assessed by a modified formalin-ethyl acetate concentration technique
    Helminth parasitic infection
    Helminth parasitic infections will be assessed using duplicate Kato-Katz thick smears

    Full Information

    First Posted
    November 18, 2021
    Last Updated
    February 17, 2022
    Sponsor
    Lao Tropical and Public Health Institute
    Collaborators
    Institut Pasteur du Laos, Seoul National University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05185973
    Brief Title
    Effects of "For-Baby" Supplementation on Young Children's Physical Growth and Diarrhea Episodes
    Acronym
    LaoBiome
    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

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 20, 2022 (Anticipated)
    Primary Completion Date
    February 19, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lao Tropical and Public Health Institute
    Collaborators
    Institut Pasteur du Laos, Seoul National University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Children, Malnutrition
    Keywords
    Malnutrition, Nutrient supplementation, For-baby, Lao PDR

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantInvestigator
    Masking Description
    The randomization scheme will be generated by an independent Statistician using a computer-generated block randomization scheme, with randomly selected block lengths of 4. Each of the two study arms will be identified by a unique 1-digit code (1, 2). The Institut Pasteur du Laos (IPL) member, unaffiliated with the study, will be responsible for assigning each of the two study codes to an intervention product and communicating this information directly to the product manufacturers. The identity of the treatment codes is stored in sealed envelopes held by the co-principal investigators (PIs) and the statistician. The envelopes will be opened only after statistical analyses of primary outcomes are completed and consensus on the interpretation of results is reached, unless required by one of the IRBs or the Project Steering Committee.
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    "For-Baby powder" supplement
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Micronutrient powder
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    "For Baby "supplements provided as powder
    Intervention Description
    One sachet daily
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Micronutrient powder provided as powder
    Intervention Description
    One sachet daily
    Primary Outcome Measure Information:
    Title
    Change in length and length-for-age Z-score
    Description
    Length of study children will be measured at the baseline, and follow-up surveys using seca baby's length measuring board.
    Time Frame
    52 weeks
    Title
    Change in weight and weight-for-age Z-score,
    Description
    Weight of study children will be measured at the baseline, and follow-up surveys, using seca baby's digital scale.
    Time Frame
    52 weeks
    Title
    Change in mid-upper circumference
    Description
    Mid- upper arm circumference will be measured the baseline, and follow-up surveys, using a mid upper arm circumference measuring tape.
    Time Frame
    52 weeks
    Secondary Outcome Measure Information:
    Title
    Incidence of diarrheal episodes
    Description
    Report of diarrheal episodes will be recorded at the baseline and follow-up surveys
    Time Frame
    52 weeks
    Title
    Number of children achieved the gross motor developmental milestones
    Description
    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
    Time Frame
    52 weeks
    Title
    Number of children with improved gut microbiota profile
    Description
    Gut microbiota will be assessed using microbiome analysis
    Time Frame
    52 weeks
    Title
    Intestinal protozoa infection
    Description
    Intestinal protozoan infections will be assessed by a modified formalin-ethyl acetate concentration technique
    Time Frame
    52 weeks
    Title
    Helminth parasitic infection
    Description
    Helminth parasitic infections will be assessed using duplicate Kato-Katz thick smears
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    23 Months
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Somphou Sayasone, PhD
    Phone
    +8562055679603
    Email
    somphou.sayasone@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dalaphone Sitthideth, MD
    Phone
    +8562055685247
    Email
    dsitthideth@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Latsamy P Siengsounthone, MD
    Organizational Affiliation
    Lao Tropical and Public Health Institute
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33022941
    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.
    Results Reference
    background
    PubMed Identifier
    28770479
    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.
    Results Reference
    background
    PubMed Identifier
    34573514
    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.
    Results Reference
    background
    PubMed Identifier
    34578878
    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.
    Results Reference
    background
    PubMed Identifier
    33750266
    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.
    Results Reference
    background
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov
    Description
    All references are published online in the peer reviewed journals

    Learn more about this trial

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

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