Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Mo… (NCT03474276) | Clinical Trial Compass
CompletedPhase 3
Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old
Central African Republic, Madagascar, Niger1,357 participantsStarted 2018-01-31
Plain-language summary
The aim of this open-label randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be studied and compared.
Who can participate
Age range
6 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged from 6 to 24 months olds.
* Moderate acute malnutrition defined by a -3 ≤ Weight/Height z-score \< -2 SD.
* Written informed consent of parents or legal guardian.
* Child able to be brought back to the centre on the two following days of inclusion.
* Child able to be followed up during at least three months.
Exclusion Criteria:
* Severe malnutrition defined by a mid upper arm circumference \< 115 mm OR Weight/Height z-score \< -3 SD OR presence of nutritional oedema.
* Clinical complications or according to the physician any clinical sign requiring care outside of the recruitment centre (referral to specialised centre or hospitalisation)
* Diarrhea with mucus and bloody stools.
* Current incompatible treatment : Antacids, Cetirizine, Digoxin, Ergotamine, Azidothymidine.
* Known hypersensitivity to macrolides or albendazole (or one of its components)
* Known allergy to enriched flours or prebiotics used in the study, or one of its components.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.