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

Malnutrition Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05185973
• Other study ID #: LAO TROPICAL AND PUBLIC HEALTH
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 20, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2022
• Source: Lao Tropical and Public Health Institute
• Contact: Somphou Sayasone, PhD
• Phone: +8562055679603
• Email: somphou.sayasone[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: September 30, 2023
• Est. primary completion date: February 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Diarrhea
• Malnutrition

Intervention

Dietary Supplement:
• "For Baby "supplements provided as powder
One sachet daily
• Micronutrient powder provided as powder
One sachet daily

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Lao Tropical and Public Health Institute	Institut Pasteur du Laos, Seoul National University

References & Publications (5)

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). pii: 3001. doi: 10.3390/nu13093001. Review. — View 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. — View Citation

Maldonado NC, Chiaraviglio J, Bru E, De Chazal L, Santos V, Nader-Macías 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. — View Citation

Schröder 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). pii: E3032. doi: 10.3390/nu12103032. Review. — View 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). pii: 2544. doi: 10.3390/ani11092544. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Incidence of diarrheal episodes	Report of diarrheal episodes will be recorded at the baseline and follow-up surveys	52 weeks
Secondary	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	52 weeks
Secondary	Number of children with improved gut microbiota profile	Gut microbiota will be assessed using microbiome analysis	52 weeks
Secondary	Intestinal protozoa infection	Intestinal protozoan infections will be assessed by a modified formalin-ethyl acetate concentration technique	52 weeks
Secondary	Helminth parasitic infection	Helminth parasitic infections will be assessed using duplicate Kato-Katz thick smears	52 weeks

External Links

•   All references are published online in the peer reviewed journals