Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition (MDF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Malnutrition With no Complications
• Intervention / Treatment: Dietary supplement: Microbiome-directed food - MAM; Dietary supplement: Ready-to-use supplementary food (RUSF); Dietary supplement: Microbiome-directed food (MDF) - SAM; Dietary supplement: Ready-to-use therapeutic food (RUTF)

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 Type: Interventional
• Enrollment (Estimated): 6200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hermann Biènou LANOU, MD., PhD.; Phone Number: +226 66557580; Email: hlanou@yahoo.ca
• Study Contact Backup: Name: Seni KOUANDA, MD., PhD; Phone Number: +226 70261462; Email: senikouanda@gmail.com

Study Locations

• Burkina Faso
  • Kadiogo
    • Ouagadougou, Kadiogo, Burkina Faso
      • LANOU Hermann Bienou
      • Contact: Hermann Biènou LANOU, MD., PhD; Phone Number: +226 66557580; Email: hlanou@yahoo.ca
      • Contact: Seni KOUANDA, MD.,PhD; Phone Number: +226 70261462; Email: senikouanda@gmail.com
      • Sub-Investigator: Hermann LANOU, PhD.
      • Sub-Investigator: Jérôme SOME, PhD
      • Principal Investigator: Seni Kouanda, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microbiome-directed food (MDF) - SAM; 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; Each SAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.; Other Names: MDF - SAM
Active Comparator: 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	Dietary supplement: Ready-to-use therapeutic food (RUTF); Each SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.; Other Names: RUTF
Experimental: Microbiome-directed food (MDF) - MAM; Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks	Dietary supplement: Microbiome-directed food - MAM; Each MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.; Other Names: MDF - MAM
Active Comparator: Ready-to-use supplementary food (RUSF); 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); Each MAM child will be supplemented with RUSF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.; Other Names: RUSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Weight-for-height (WHZ) z-score	(WHZ z-score at admission) - (WHZ z-score at 12 weeks)	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)	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)	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	Up to 12 weeks
Dropouts	Lost to follow up	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	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	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.	up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness	Cost-effectiveness, as defined by the incremental cost per child cured according to the program and per child cured sustainedly	12 weeks; 24 weeks

Collaborators and Investigators

• Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
• Collaborators: Bill and Melinda Gates Foundation; Ministry of Health, Burkina Faso
• Investigators: Principal Investigator: Seni KOUANDA, MD., PhD, Institut de Recherche en Sciences de la Santé, Burkina-Faso

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: INV-016380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No