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Recruiting NCT06382857

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

No phase Interventional Malnutrition, Child

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MDF, RUTF, RUSF.
Who it may be relevant to
Registry conditions: Malnutrition, Child. Basic parameters: 6 months — 23 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Niger
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement MDF
    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.
  • Dietary supplement RUTF
    RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter
  • Dietary supplement RUSF
    RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter

Primary outcome measures

  • Programmatic recovery by 12 weeks from admission [Time frame: 12 weeks]
  • Sustained recovery at 24 weeks from admission [Time frame: 24 weeks]
Secondary outcome measures (12)
  • Default [Time frame: 12 weeks]
  • Non-response [Time frame: 12 weeks]
  • Time to recovery [Time frame: 12 weeks]
  • For MAM children: Deterioration to SAM [Time frame: 24 weeks]
  • Change in weight gain [Time frame: From enrollment to 4, 8 and 12 weeks]
  • Change in weight-for-length Z (WLZ) [Time frame: From enrollment to 4, 8 and 12 weeks]
  • Change in length-for-age Z (LAZ) [Time frame: From enrollment to 4, 8 and 12 weeks]
  • Change in weight-for-age Z (WAZ) [Time frame: From enrollment to 4, 8 and 12 weeks]
  • Change in MUAC [Time frame: From enrollment to 4, 8 and 12 weeks]
  • Serious adverse events [Time frame: 24 weeks]
  • Hospitalization [Time frame: 24 weeks]
  • Death [Time frame: 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Niger · 1 center
  • Epicentre Niger — Maradi

Identifiers

NCT: NCT06382857 · 823779-MDF Niger

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗