BridgeMD
Tests treatment safety and results for Malnutrition, Child
Official title Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
ClinicalTrials.gov ID: NCT06382857
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 23
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Maradi, Niger
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 23 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maradi, Niger. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.