NCT05185973

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

November 18, 2021

Last Update Submit

February 17, 2022

Conditions

ChildrenMalnutrition

Keywords

MalnutritionNutrient supplementationFor-babyLao PDR

Outcome Measures

Primary Outcomes (3)

  • 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.

    52 weeks

  • 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.

    52 weeks

  • 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.

    52 weeks

Secondary Outcomes (5)

  • Incidence of diarrheal episodes

    52 weeks

  • Number of children achieved the gross motor developmental milestones

    52 weeks

  • Number of children with improved gut microbiota profile

    52 weeks

  • Intestinal protozoa infection

    52 weeks

  • Helminth parasitic infection

    52 weeks

Study Arms (2)

"For-Baby powder" supplement

EXPERIMENTAL

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

Micronutrient powder

PLACEBO COMPARATOR

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

Interventions

"For Baby "supplements provided as powderDIETARY_SUPPLEMENT

One sachet daily

"For-Baby powder" supplement
Micronutrient powder provided as powderDIETARY_SUPPLEMENT

One sachet daily

Micronutrient powder

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 33022941BACKGROUND

  • 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.

    PMID: 28770479BACKGROUND

  • 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.

    PMID: 34573514BACKGROUND

  • 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.

    PMID: 34578878BACKGROUND

  • 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.

    PMID: 33750266BACKGROUND

Related Links

MeSH Terms

Conditions

Malnutrition

Interventions

Powders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Latsamy P Siengsounthone, MD

    Lao Tropical and Public Health Institute

    STUDY DIRECTOR

Central Study Contacts

Somphou Sayasone, PhD

CONTACT

+8562055679603somphou.sayasone@yahoo.com

Dalaphone Sitthideth, MD

CONTACT

+8562055685247dsitthideth@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

November 18, 2021

First Posted

January 11, 2022

Study Start

March 20, 2022

Primary Completion

February 19, 2023

Study Completion

September 30, 2023

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share