Clinical trial NCT06382857: Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
Official title: Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition, Child
Keywords: Malnutrition
SAM
MAM
Child
MDF
Microbiome
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Epicentre, Niger
name: National Nutrition Direction, Niger
name: Ministry of Public Health and Social Affairs, Niger
name: Regional Direction of Public Health, Maradi
First posted: 2024-04-24
Enrollment: 7356
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)
* Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection
* Known contraindication/ hypersensitivity/allergy to study interventions (chickpea/soy flour, banana, peanut)
* Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community

Primary outcomes:
measure: Programmatic recovery by 12 weeks from admission
timeFrame: 12 weeks
measure: Sustained recovery at 24 weeks from admission
timeFrame: 24 weeks
Secondary outcomes:
measure: Default
timeFrame: 12 weeks
measure: Non-response
timeFrame: 12 weeks
measure: Time to recovery
timeFrame: 12 weeks
measure: For MAM children: Deterioration to SAM
timeFrame: 24 weeks
measure: Change in weight gain
timeFrame: From enrollment to 4, 8 and 12 weeks
measure: Change in weight-for-length Z (WLZ)
timeFrame: From enrollment to 4, 8 and 12 weeks
measure: Change in length-for-age Z (LAZ)
timeFrame: From enrollment to 4, 8 and 12 weeks
measure: Change in weight-for-age Z (WAZ)
timeFrame: From enrollment to 4, 8 and 12 weeks
measure: Change in MUAC
timeFrame: From enrollment to 4, 8 and 12 weeks
measure: Serious adverse events
timeFrame: 24 weeks
measure: Hospitalization
timeFrame: 24 weeks
measure: Death
timeFrame: 24 weeks
measure: Motor, cognitive, language, social-emotional, and mental health skills
timeFrame: 24 weeks
measure: Cost effectiveness
timeFrame: 24 weeks
measure: Dietary intake
timeFrame: 24 weeks
measure: Adherence
timeFrame: 12 weeks
measure: Microbiome profile at enrollment, week 4, program discharge, and study discharge
timeFrame: 24 weeks
measure: Plasma proteome profile at enrollment, week 4, program discharge, and study discharge
timeFrame: 24 weeks
measure: Environmental enteric dysfunction at enrollment, program discharge, and study discharge
timeFrame: 24 weeks
measure: Change of fat mass and fat-free mass at program discharge and study discharge
timeFrame: 24 weeks
measure: Micronutrient status at enrollment, program discharge and study discharge
timeFrame: 24 weeks
measure: Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Maradi
country: Niger
facility: Epicentre Niger
Study officials:
affiliation: Epicentre
name: Rebecca Grais, PhD
role: STUDY_CHAIR
References: