Acute Malnutrition With no ComplicationsMDFNCT05586139
Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition
A study testing Microbiome-directed food - MAM, Ready-to-use supplementary food (RUSF) and Microbiome-directed food (MDF) - SAM in people with Acute Malnutrition With no Complications, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.
Trial summary
The goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Acute Malnutrition With no Complications
- What is being tested?
- Microbiome-directed food - MAM, Ready-to-use supplementary food (RUSF) and Microbiome-directed food (MDF) - SAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,200 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 6 and 23 months
- Moderate wasting: WHZ < -2 and ≥ -3 or MUAC < 125 mm and ≥ 115mm or - Severe wasting: WHZ < -3 or MUAC < 115 mm
Who cannot join
- Bilateral pitting edema
- Not eating/lack of appetite
- Current illness medical complications requiring inpatient treatment
- Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection
- Known contraindication/hypersensitivity/allergy to MDCF of RUSF ingredients (chickpea flour, soy flour, banana, peanut)
- Relapse from MAM treatment or transfer from SAM treatment
- Children recently (<2 months) or enrolled in a nutrition program
- Residence outside the study area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Burkina Faso1 site
LANOU Hermann Bienou
Ouagadougou, Kadiogo
Hermann Biènou LANOU, MD., PhD, +226 66557580, hlanou@yahoo.ca
Seni KOUANDA, MD.,PhD, +226 70261462, senikouanda@gmail.com
About this study
Official title: Efficacy of a Food Targeting the Microbiota for a Sustained Recovery of Children With Uncomplicated Acute Malnutrition
The goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. The main questions are:
- Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ?
- Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher sustained recovery rate compared to standard of care ? The MDF will be compared to Ready-to-use supplementary food (RUSF) for moderately malnourished children, and to Ready-to-use therapeutic food (RUTF) for severely malnourished children to see the effects on recovery and sustained recovery rate.
Read the detailed description
In this stratified trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for MAM and 1:1 for SAM.
The supplementation will be done on daily basis according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment is done. Those who recovered before or at this point, will be subsequently followed up monthly up to 3 month for sustained recovery assessment.
Follow-up visits will be done at the health center every week for severe acute malnutrition (SAM) children and every two weeks for moderate acute malnutrition (SAM) children.
At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.
- Conditions
- Acute Malnutrition With no Complications
- Being tested
- Microbiome-directed food - MAM, Ready-to-use supplementary food (RUSF), Microbiome-directed food (MDF) - SAM, Ready-to-use therapeutic food (RUTF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome-directed food - MAMDietary supplement
Also called MDF - MAM
Each MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Ready-to-use supplementary food (RUSF)Dietary supplement
Also called RUSF
Each MAM child will be supplemented with RUSF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Microbiome-directed food (MDF) - SAMDietary supplement
Also called MDF - SAM
Each SAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Ready-to-use therapeutic food (RUTF)Dietary supplement
Also called RUTF
Each SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Microbiome-directed food (MDF) - MAM | Experimental | Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks Receives: Dietary Supplement: Microbiome-directed food - MAM |
| Ready-to-use supplementary food (RUSF) | Active comparator | Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks Receives: Dietary Supplement: Ready-to-use supplementary food (RUSF) |
| Microbiome-directed food (MDF) - SAM | Experimental | Each (SAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks of supplementation. Receives: Dietary Supplement: Microbiome-directed food (MDF) - SAM |
| Ready-to-use therapeutic food (RUTF) | Active comparator | Each (SAM) child will receive a daily ration of RUTF corresponding to his weight, for maximum 12 weeks of supplementation Receives: Dietary Supplement: Ready-to-use therapeutic food (RUTF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Programmatic recovery defined by Weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm
Moderate cute malnutrition is defined by Weight-for-height (WHZ) < - 2 z-score or mid-upper arm circumference (MUAC) < 125 mm. Higher WHZ z-score (≥ - 2) or mid-upper arm circumference (MUAC) ≥ 125 mm means better outcome synonym of recovery
Measured: 12th weeks from admission to the supplementation program
Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm
Children who sustain recovery (WHZ ≥ - 2 z-score or MUAC ≥ 125 mm) up to 24 weeks
Measured: 24 weeks from admission to the supplementation program
Secondary outcomes (8)
Mean change in Weight-for-height (WHZ) z-score
(WHZ z-score at admission) - (WHZ z-score at 12 weeks)
Measured: 12 weeks from admission to the supplementation program
Mean change in Weight-for-age (WAZ) z-score
(WAZ z-score at admission) - (WAZ z-score at 12 weeks)
Measured: 12 weeks from admission to the supplementation program
Mean change in Height-for-age (HAZ) z-score
(HAZ z-score at admission) - (HAZ z-score at 12 weeks)
Measured: 12 weeks from admission to the supplementation program
Time to recovery
Determined by the number of days from admission to programmatic recovery among those who recovered
Measured: Up to 12 weeks
Dropouts
Lost to follow up
Measured: 12 weeks
Non-response defined by WHZ < -2 z-score, or a MUAC < 125 mm
Children who failed to attain a weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm
Measured: 12 weeks
Complications
- Edema
- Fever >39°C or hypothermia <35°C
- Severe dehydration
- Repeated or incessant vomiting
- Severe respiratory problem (IMCI criteria)
- severe anemia (significant pallor with difficulty of breathing)
- Severe malaria
- Abscess or extensive skin lesions
- Very weak, apathetic, unconscious
- Seizure
Measured: up to 12 weeks
Failure
Absence of weight gain, assessed at the 3rd consecutive visit;
- Weight loss since admission to the program, assessed at the 1st visit after admission;
- Loss of 5% of body weight compared to admission weight.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study startOct 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Malnutrition With no ComplicationsStudies 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
- Individually randomized and controlled trial, Stratified by severity of malnutrition: * 2 arms for Severe Acute malnutrition * 2 arms for Moderate acute Malnutrition
- Masking
- None (open label)
- Enrolment
- 6,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Burkina Faso, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Hermann Lanou, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Investigators
- Seni KOUANDA, MD., PhD, Principal investigator, Institut de Recherche en Sciences de la Santé, Burkina-Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586139
- Sponsor's protocol ID
- INV-016380
- Acronym
- MDF
- Status last verified
- Mar 2024
- First submitted
- 22 Sep 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lanou HB, Some JW, Koumbem MAA, Kouanda S. Microbiome-directed food to promote sustained recovery in children with uncomplicated acute malnutrition: protocol for a randomized controlled trial in Burkina Faso. BMC Nutr. 2025 May 13;11(1):92. doi: 10.1186/s40795-025-01045-x.
PubMed 40361242
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Food Targeting the Microbiota for a Sustained Recovery of Children With Uncomplicated Acute Malnutrition
- ClinicalTrials.gov ID
- NCT05586139
- Acronym / sponsor ID
- MDF / INV-016380
- Conditions
- Acute Malnutrition With no Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,200 participants (estimated)
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina FasoOther government
- Collaborators
- Ministry of Health, Burkina Faso, Bill and Melinda Gates Foundation
- Study start
- Oct 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Oct 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 goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. The main questions are:
- Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ?
- Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher sustained recovery rate compared to standard of care ? The MDF will be compared to Ready-to-use supplementary food (RUSF) for moderately malnourished children, and to Ready-to-use therapeutic food (RUTF) for severely malnourished children to see the effects on recovery and sustained recovery rate.
Detailed description
In this stratified trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for MAM and 1:1 for SAM.
The supplementation will be done on daily basis according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment is done. Those who recovered before or at this point, will be subsequently followed up monthly up to 3 month for sustained recovery assessment.
Follow-up visits will be done at the health center every week for severe acute malnutrition (SAM) children and every two weeks for moderate acute malnutrition (SAM) children.
At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Individually randomized and controlled trial, Stratified by severity of malnutrition: * 2 arms for Severe Acute malnutrition * 2 arms for Moderate acute Malnutrition
| Arm | Type | Receives |
|---|---|---|
| Microbiome-directed food (MDF) - MAM | Experimental | Dietary Supplement: Microbiome-directed food - MAMEach (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks |
| Ready-to-use supplementary food (RUSF) | Active comparator | Dietary Supplement: Ready-to-use supplementary food (RUSF)Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks |
| Microbiome-directed food (MDF) - SAM | Experimental | Dietary Supplement: Microbiome-directed food (MDF) - SAMEach (SAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks of supplementation. |
| Ready-to-use therapeutic food (RUTF) | Active comparator | Dietary Supplement: Ready-to-use therapeutic food (RUTF)Each (SAM) child will receive a daily ration of RUTF corresponding to his weight, for maximum 12 weeks of supplementation |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 6 and 23 months
- Moderate wasting: WHZ < -2 and ≥ -3 or MUAC < 125 mm and ≥ 115mm or - Severe wasting: WHZ < -3 or MUAC < 115 mm
Key exclusion criteria (8 listed)
- Bilateral pitting edema
- Not eating/lack of appetite
- Current illness medical complications requiring inpatient treatment
- Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection
- Known contraindication/hypersensitivity/allergy to MDCF of RUSF ingredients (chickpea flour, soy flour, banana, peanut)
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 |
|---|---|---|
| Microbiome-directed food - MAMAlso: MDF - MAMEach MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks. | Dietary supplement | Microbiome-directed food (MDF) - MAM |
| Ready-to-use supplementary food (RUSF)Also: RUSFEach MAM child will be supplemented with RUSF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks. | Dietary supplement | Ready-to-use supplementary food (RUSF) |
| Microbiome-directed food (MDF) - SAMAlso: MDF - SAMEach SAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks. | Dietary supplement | Microbiome-directed food (MDF) - SAM |
| Ready-to-use therapeutic food (RUTF)Also: RUTFEach SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks. | Dietary supplement | Ready-to-use therapeutic food (RUTF) |
Primary outcome
Programmatic recovery defined by Weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm
Time frame: 12th weeks from admission to the supplementation program
Moderate cute malnutrition is defined by Weight-for-height (WHZ) < - 2 z-score or mid-upper arm circumference (MUAC) < 125 mm. Higher WHZ z-score (≥ - 2) or mid-upper arm circumference (MUAC) ≥ 125 mm means better outcome synonym of recovery
Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm
Time frame: 24 weeks from admission to the supplementation program
Children who sustain recovery (WHZ ≥ - 2 z-score or MUAC ≥ 125 mm) up to 24 weeks
8 secondary outcomes
Mean change in Weight-for-height (WHZ) z-score
Time frame: 12 weeks from admission to the supplementation program
Mean change in Weight-for-age (WAZ) z-score
Time frame: 12 weeks from admission to the supplementation program
Mean change in Height-for-age (HAZ) z-score
Time frame: 12 weeks from admission to the supplementation program
Time to recovery
Time frame: Up to 12 weeks
Dropouts
Time frame: 12 weeks
Non-response defined by WHZ < -2 z-score, or a MUAC < 125 mm
Time frame: 12 weeks
Complications
Time frame: up to 12 weeks
Failure
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 40361242Lanou HB, Some JW, Koumbem MAA, Kouanda S. Microbiome-directed food to promote sustained recovery in children with uncomplicated acute malnutrition: protocol for a randomized controlled trial in Burkina Faso. BMC Nutr. 2025 May 13;11(1):92. doi: 10.1186/s40795-025-01045-x.
- 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.
Seni KOUANDA, MD., PhD principal investigator
Institut de Recherche en Sciences de la Santé, Burkina-Faso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiome-directed food - MAM, Ready-to-use supplementary food (RUSF) and Microbiome-directed food (MDF) - SAM in people with Acute Malnutrition With no Complications, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hermann Biènou LANOU, MD., PhD. (+226 66557580, hlanou@yahoo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Programmatic recovery defined by Weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm (time frame: 12th weeks from admission to the supplementation program). The study lists 2 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 NCT05586139, which also lists 1 linked publication.
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 13 Mar 2024.