ChildrenLaoBiomeNCT05185973
Effects of "For-Baby" Supplementation on Young Children's Physical Growth and Diarrhea Episodes
A study testing "For Baby "supplements provided as powder and Micronutrient powder provided as powder in people with Children and Malnutrition, run by Lao Tropical and Public Health Institute.
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… Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Children, Malnutrition
- What is being tested?
- "For Baby "supplements provided as powder and Micronutrient powder provided as powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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).
Read the 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.
- Conditions
- Children, Malnutrition
- Being tested
- "For Baby "supplements provided as powder, Micronutrient powder provided as powder
- Keywords
- Malnutrition, Nutrient supplementation, For-baby, Lao PDR
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"For Baby "supplements provided as powderDietary supplement
One sachet daily
Micronutrient powder provided as powderDietary supplement
One sachet daily
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: Dietary Supplement: Micronutrient powder provided as powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 52 weeks
Secondary outcomes (5)
Incidence of diarrheal episodes
Report of diarrheal episodes will be recorded at the baseline and follow-up surveys
Measured: 52 weeks
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
Measured: 52 weeks
Number of children with improved gut microbiota profile
Gut microbiota will be assessed using microbiome analysis
Measured: 52 weeks
Intestinal protozoa infection
Intestinal protozoan infections will be assessed by a modified formalin-ethyl acetate concentration technique
Measured: 52 weeks
Helminth parasitic infection
Helminth parasitic infections will be assessed using duplicate Kato-Katz thick smears
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start20 Mar 2022 (estimated)
- Primary completion19 Feb 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lao Tropical and Public Health Institute
- Sponsor type
- Other government
- Collaborators
- Institut Pasteur du Laos, Seoul National University
- Responsible party
- Principal investigator, Somphou SAYASONE, Lao Tropical and Public Health Institute
- Investigators
- Latsamy P Siengsounthone, MD, Study director, Lao Tropical and Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185973
- Sponsor's protocol ID
- LAO TROPICAL AND PUBLIC HEALTH
- Acronym
- LaoBiome
- Status last verified
- Feb 2022
- First submitted
- 18 Nov 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33022941Maldonado 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.
PubMed 28770479Vadopalas 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.
PubMed 34573514Barkhidarian 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.
PubMed 34578878Hajare 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.
PubMed 33750266
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05185973
- Acronym / sponsor ID
- LaoBiome / LAO TROPICAL AND PUBLIC HEALTH
- Conditions
- Children, Malnutrition
- Keywords
- Malnutrition, Nutrient supplementation, For-baby, Lao PDR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Lao Tropical and Public Health InstituteOther government
- Collaborators
- Institut Pasteur du Laos, Seoul National University
- Study start
- 20 Mar 2022 (estimated)
- Primary completion
- 19 Feb 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| "For-Baby powder" supplement | Experimental | Dietary Supplement: "For Baby "supplements provided as powderFor-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 | Placebo comparator | Dietary Supplement: Micronutrient powder provided as powderMicronutrient 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. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "For Baby "supplements provided as powderOne sachet daily | Dietary supplement | "For-Baby powder" supplement |
| Micronutrient powder provided as powderOne sachet daily | Dietary supplement | Micronutrient powder |
Primary outcome
Change in length and length-for-age Z-score
Time frame: 52 weeks
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,
Time frame: 52 weeks
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
Time frame: 52 weeks
Mid- upper arm circumference will be measured the baseline, and follow-up surveys, using a mid upper arm circumference measuring tape.
5 secondary outcomes
Incidence of diarrheal episodes
Time frame: 52 weeks
Number of children achieved the gross motor developmental milestones
Time frame: 52 weeks
Number of children with improved gut microbiota profile
Time frame: 52 weeks
Intestinal protozoa infection
Time frame: 52 weeks
Helminth parasitic infection
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 33022941Schroder 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.
- Background: PubMed 28770479Maldonado 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.
- Background: PubMed 34573514Vadopalas 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.
- Background: PubMed 34578878Barkhidarian 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.
- Background: PubMed 33750266Hajare 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.
- All references are published online in the peer reviewed journalsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Latsamy P Siengsounthone, MD study director
Lao Tropical and Public Health Institute
Questions about this trial
What is this clinical trial studying?
A study testing "For Baby "supplements provided as powder and Micronutrient powder provided as powder in people with Children and Malnutrition, run by Lao Tropical and Public Health Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Somphou Sayasone, PhD (+8562055679603, somphou.sayasone@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in length and length-for-age Z-score (time frame: 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185973, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.