Health Trials

Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

ConditionMalnutrition, Child
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-23
SponsorEpicentre

About this trial

This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

for children with Severe Acute Malnutrition (SAM): MUAC < 115 mm and/or WLZ < -3 and/or mild (+) or moderate (++) edema

for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC < 125 mm and/or -3 ≤ WHZ < -2

Caregiver providing informed consent

Disqualifiers

Medical complications requiring inpatient treatment, as identified by the national protocol

Not eating/lack of appetite (as informed by appetite test and investigator judgement)

Re-admission into the program within 2 months of previous default

for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)

Trial design

Design model

Parallel

Treatments tested in this trial

  • MDF

    Dietary supplement

    MDF will be provided to children on a weekly basis for children with SAM and bi-weekly basis for children with MAM at the health center until programmatic recovery but not thereafter.

  • RUTF

    Dietary supplement

    RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter

  • RUSF

    Dietary supplement

    RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter

Treatment groups

7,356 Participants
are divided into 2 treatment groups
Group A: Microbiome directed food (MDF)Experimental treatment 1 intervention
Group B: Standard nutritional treatment (RUTF/RUSF)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Programmatic recovery by 12 weeks from admission

Defined as the proportion of SAM and MAM children achieving a WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema during 2 consecutive visits

Time frame
12 weeks
2

Sustained recovery at 24 weeks from admission

Proportion of recovered SAM and MAM children with WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema

Time frame
24 weeks

Secondary outcomes

1

Default

Defined as 2 consecutive missed scheduled program visits

Time frame
12 weeks
2

Non-response

Defined as WLZ \< -2 or MUAC \< 125 mm during 2 consecutive visits, or for SAM children only: persistent edema at 12 weeks

Time frame
12 weeks
3

Time to recovery

Measured as days from admission to programmatic recovery among recovered children

Time frame
12 weeks
4

For MAM children: Deterioration to SAM

Weight-for-height z-score (WHZ) inferior to -3

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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

Epicentre

Lead sponsor

Harvard School of Public Health (HSPH)

Sponsor institution

Epicentre, Niger

Collaborator

National Nutrition Direction, Niger

Collaborator

Ministry of Public Health and Social Affairs, Niger

Collaborator

Regional Direction of Public Health, Maradi

Collaborator

Source ClinicalTrials.gov
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