Clinical trial NCT03474276: Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old
Official title: A Multi-center, Randomized Controlled Comparison of Three Renutrition Strategies for the Management of Moderate Acute Malnutrition Among Children From 6 to 24 Months (Madagascar, Niger, Central African Republic and Senegal)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate Acute Malnutrition
Keywords: Children
Africa
Metagenomic
Prebiotic
Randomized Controlled Trial
Pragmatic trial
Azithromycin
Cognitive impairment
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Action Contre la Faim
name: Centre de Recherches Médicales et Sanitaires CERMES Niger
name: Institut Pasteur de Madagascar
name: Institut Pasteur de Bangui
name: Institut Pasteur de Dakar
First posted: 2018-03-22
Enrollment: 1357
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recovery at three month
timeFrame: Three month
Secondary outcomes:
measure: Cognitive-motor development (Senegal)
timeFrame: Baseline, three, six and nine months after inclusion
measure: Comparison of the Operational Taxonomic Unit composition of stool samples according to the nutritional status
timeFrame: Baseline, three and six months after inclusion
Other outcomes:
Locations:
city: Bangui
country: Central African Republic
facility: Institut Pasteur de bangui - Centre Nutritionnel de Gbangouma et Centre de Santé Saint-Joseph
city: Antananarivo
country: Madagascar
facility: Institut Pasteur de Madagascar - CRENAM Andohotapenaka et Centre de Santé Mitia
city: Maradi
country: Niger
facility: Centre de santé intégré ACF de Tchake et d'Issawanne
city: Dakar
country: Senegal
facility: Institut Pasteur de Dakar - Poste de Santé Hamo V
state: Guédiawaye
Study officials:
affiliation: Institut Pasteur
name: Ronan JAMBOU, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Pasteur
name: Muriel Vray, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vray M, Hedible BG, Adam P, Tondeur L, Manirazika A, Randremanana R, Mainassara H, Briend A, Artaud C, von Platen C, Altmann M, Jambou R. A multicenter, randomized controlled comparison of three renutrition strategies for the management of moderate acute malnutrition among children aged from 6 to 24 months (the MALINEA project). Trials. 2018 Dec 4;19(1):666. doi: 10.1186/s13063-018-3027-3.