Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition

NCT05586139 | Not Yet Recruiting

• 1 other identifier: INV-016380
• Study Type: interventional
• Target: 6,200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Malnutrition With no Complications

Outcome Measures

Primary Outcomes (2)

• 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

  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

  24 weeks from admission to the supplementation program

Secondary Outcomes (8)

• Mean change in Weight-for-height (WHZ) z-score

  12 weeks from admission to the supplementation program

• Mean change in Weight-for-age (WAZ) z-score

  12 weeks from admission to the supplementation program

• Mean change in Height-for-age (HAZ) z-score

  12 weeks from admission to the supplementation program

• Time to recovery

  Up to 12 weeks

• Dropouts

  12 weeks

Other Outcomes (1)

• Cost-effectiveness

  12 weeks; 24 weeks

Study Arms (4)

Microbiome-directed food (MDF) - MAM

EXPERIMENTAL

Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks

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

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.

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

Dietary Supplement: Ready-to-use therapeutic food (RUTF)

Interventions

Microbiome-directed food - MAM DIETARY_SUPPLEMENT

Each MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.

Also known as: MDF - MAM

Microbiome-directed food (MDF) - MAM

Ready-to-use supplementary food (RUSF) DIETARY_SUPPLEMENT

Each MAM child will be supplemented with RUSF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.

Also known as: RUSF

Ready-to-use supplementary food (RUSF)

Microbiome-directed food (MDF) - SAM DIETARY_SUPPLEMENT

Each SAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.

Also known as: MDF - SAM

Microbiome-directed food (MDF) - SAM

Ready-to-use therapeutic food (RUTF) DIETARY_SUPPLEMENT

Each SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.

Also known as: RUTF

Ready-to-use therapeutic food (RUTF)

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherche en Sciences de la Sante, Burkina Faso: lead
• Ministry of Health, Burkina Faso: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

LANOU Hermann Bienou

Ouagadougou, Kadiogo, Burkina Faso

Location

Related Publications (1)

• 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.

  PMID: 40361242 DERIVED

MeSH Terms

Interventions

milk-derived factor; S-Adenosylmethionine

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Seni KOUANDA, MD., PhD

  Institut de Recherche en Sciences de la Santé, Burkina-Faso

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermann Biènou LANOU, MD., PhD.

CONTACT

+226 66557580; hlanou@yahoo.ca

Seni KOUANDA, MD., PhD

CONTACT

+226 70261462; senikouanda@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Individually randomized and controlled trial, Stratified by severity of malnutrition: * 2 arms for Severe Acute malnutrition * 2 arms for Moderate acute Malnutrition

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 19, 2022
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)