Health TrialsbyHealthPanel

Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition

ConditionAcute Malnutrition With no Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-23
SponsorInstitut de Recherche en Sciences de la Sante, Burkina Faso

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

6,200 Participants
are divided into 4 treatment groups
Group A: Microbiome-directed food (MDF) - MAMExperimental treatment 1 intervention
Group B: Ready-to-use supplementary food (RUSF)Active comparator 1 intervention
Group C: Microbiome-directed food (MDF) - SAMExperimental treatment 1 intervention
Group D: Ready-to-use therapeutic food (RUTF)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12th weeks from admission to the supplementation program
2

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

Time frame
24 weeks from admission to the supplementation program

Secondary outcomes

1

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

(WHZ z-score at admission) - (WHZ z-score at 12 weeks)

Time frame
12 weeks from admission to the supplementation program
2

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

(WAZ z-score at admission) - (WAZ z-score at 12 weeks)

Time frame
12 weeks from admission to the supplementation program
3

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

(HAZ z-score at admission) - (HAZ z-score at 12 weeks)

Time frame
12 weeks from admission to the supplementation program
4

Time to recovery

Determined by the number of days from admission to programmatic recovery among those who recovered

Time frame
Up to 12 weeks

Other outcomes

1

Cost-effectiveness

Cost-effectiveness, as defined by the incremental cost per child cured according to the program and per child cured sustainedly

Time frame
12 weeks; 24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut de Recherche en Sciences de la Sante, Burkina Faso

Lead sponsor

Ministry of Health, Burkina Faso

Collaborator

Bill and Melinda Gates Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: