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

Moderate Acute Malnutrition Clinical Trial

— MALINEA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474276
• Other study ID #: 2014-062
• Secondary ID: FPC N° 2013-4025
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2022
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1357
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Moderate Acute Malnutrition

Intervention

Drug:
• Azythromycin
Administration of azythromycin to the child at inclusion (3 days) 20 mgs/kgs/day : three days

Dietary Supplement:
• Inuline and fructo-oligosaccharides
Administration of inuline and fructo-oligosaccharides (Synergy1) 2g/day, mixed with the fortified blend flour given to the child through the whole intervention.

Drug:
• Albendazole
Administration of Albendazole at inclusion of the child : 200mgs, one administration

Dietary Supplement:
• Fortified blend flour
Children from 6 to 11 months : 200 grams / day Children from 12 to 24 months : 300 grams / day Compostion of the fortified blend flour per 100 grams : either : Mil (whole grains): 58,56 g/100g, Soybeans (fat meal): 16,54g/100g Peanuts (roasted seeds): 8,75g/100g, Cane sugar: 7,35 g/100g Whole milk (Powder): 7,56g/100g, MSV MAM: 0,28g/100g, iodized salt :0,45g/100g, CaC03: 0,48g/100g,Amylase BAN: 0,03g/100g OR Corn (whole grains): 53,29g/100g, Soybeans (dry seeds): 17,82g/100g, Peanuts (roasted seeds): 9,00 g/100g, Cane sugar: 11,00 Whole milk (Powder): 5,00g/100g, Soybean Oil (Purified): 1,24g/100g, Peanut oil (Purified): 1,13g/100g, MSV MAM: 0,27g/100g, iodized salt: 0,53 g/100g, Ca3(PO4)2: 0,62g/100g, KCl: 0,09g/100g

Locations

Country	Name	City	State
Central African Republic	Institut Pasteur de bangui - Centre Nutritionnel de Gbangouma et Centre de Santé Saint-Joseph	Bangui
Madagascar	Institut Pasteur de Madagascar - CRENAM Andohotapenaka et Centre de Santé Mitia	Antananarivo
Niger	Centre de santé intégré ACF de Tchake et d'Issawanne	Maradi
Senegal	Institut Pasteur de Dakar - Poste de Santé Hamo V	Dakar	Guédiawaye

Sponsors (6)

Lead Sponsor	Collaborator
Institut Pasteur	Action Contre la Faim, Centre de Recherches Médicales et Sanitaires CERMES Niger, Institut Pasteur de Bangui, Institut Pasteur de Dakar, Institut Pasteur de Madagascar

Countries where clinical trial is conducted

Central African Republic,  Madagascar,  Niger,  Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery at three month	Recovery at three months, defined by: Weight/Size Z-score = -1.5 SD measured at 2 following consultations without hospitalization, transfer, death or lost to follow up	Three month
Secondary	Cognitive-motor development (Senegal)	Developmental Milestones Checklist II (DMC II) questionnaire to evaluate participating children cognitive and motor abilities.	Baseline, three, six and nine months after inclusion
Secondary	Comparison of the Operational Taxonomic Unit composition of stool samples according to the nutritional status	Each sample will be ADN extracted using Quiagen technology 16S and 18S amplification will be conducted following Hughert et al. (2014) and Tang et al. (2015). PCR products will be sequenced using NGS Illumina plateform. Sequences will be analyzed using Mothur 1.37.6 software and Silva data base (https://www.arb-silva.de/browser). OTU (Operational Taxonomic Unit) composition will be determined for each sample.; OTU composition of samples from well and malnourished children will be compared using mann whitney test, and shift in OTUs during renutrition will be analysed using survival analysis.	Baseline, three and six months after inclusion

External Links

•   Action contre la faim [Action against hunger] : International humanitarian organization providing communities with access to safe water and sustainable solutions to hunger.
•   GRET: French development NGO fighting poverty and inequalities, providing solutions for development [150 projects per year in 30 countries]
•   Institut Pasteur: Private non-profit foundation whose mission is to prevent and treat diseases through research, teaching, and public health initiatives.