Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old (MALINEA)

Pasteur Institute

Status and phase: Completed; Phase 3

Conditions: Moderate Acute Malnutrition

Treatments: Drug: Albendazole; Drug: Azythromycin; Dietary Supplement: Fortified blend flour; Dietary Supplement: Inuline and fructo-oligosaccharides

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03474276

FPC N° 2013-4025 (Other Grant/Funding Number)

2014-062

Details and patient eligibility

About

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.

Full description

The main objective of this study is to improve the nutrition strategy used to take in charge moderate acute malnutrition (MAM) which is the major milestone before severe malnutrition. This will be based on the modulation of the gut microbiota with adjunct product added to standard nutrition flours.

The purpose of the MALINEA study is to compare three management strategies for Moderate Acute Malnutrition (MAM) in children aged between 6 months and 2 years old on recovery defined by a weight/size gain at 3 months.

The 3 groups will be compared on several anthropometric measurements [Weight, length, Mid Upper Arm Circumference (MUAC)], clinical characteristics, adherence and tolerance to interventions between before and after a 3 months intervention Cognitive development of children (Senegal) will also be studied and compared, at inclusion, 3 months and 6 months after inclusion.

The investigators will also investigate the microbiomes of malnourished children at inclusion and at 3 and 6 months after inclusion to compare it to the ones of normonourished children.

Enrollment: 1,357 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,357 participants in 3 patient groups

Control group

Active Comparator group

Description:

Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months). 200 grams / day for children between 6 and 11 months. 300 grams / day for children aged from 12 to 24 months old.

Treatment:

Dietary Supplement: Fortified blend flour

Drug: Albendazole

Azythromycin

Active Comparator group

Description:

Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months) associated to Azythromycin, 20mg/kgs/days during the three first days of the study.

Treatment:

Dietary Supplement: Fortified blend flour

Drug: Albendazole

Drug: Azythromycin

Prebiotic

Active Comparator group

Description:

Fortified Blended Flour mixed with Inuline and fructo-oligosaccharides (Synergy1) 2g/day, given to the child through the whole intervention (in association with a single dose of Albendazole at inclusion for children older than 12 months)

Treatment:

Dietary Supplement: Inuline and fructo-oligosaccharides

Dietary Supplement: Fortified blend flour

Drug: Albendazole