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Completed

NCT Number: NCT03474276

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

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.

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Key information

Conditions

Moderate Acute Malnutrition Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Pasteur de bangui - Centre Nutritionnel de Gbangouma et Centre de Santé Saint-Joseph, Bangui, Central African Republic

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azythromycin

Drug

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

Other names: Antibiotics

Inuline and fructo-oligosaccharides

Dietary Supplement

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

Other names: Prebiotic

Albendazole

Drug

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

Other names: Antiparasitic drug

Fortified blend flour

Dietary Supplement

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

Other names: Lacteal flour

Primary outcomes

  1. Recovery at three month

    Time frame: 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

Secondary outcomes

  1. Cognitive-motor development (Senegal)

    Time frame: Baseline, three, six and nine months after inclusion

    Developmental Milestones Checklist II (DMC II) questionnaire to evaluate participating children cognitive and motor abilities.

  2. Comparison of the Operational Taxonomic Unit composition of stool samples according to the nutritional status

    Time frame: Baseline, three and six months after inclusion

    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.

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Action Contre la Faim
  • Centre de Recherches Médicales et Sanitaires CERMES Niger
  • Institut Pasteur de Bangui
  • Institut Pasteur de Dakar
  • Institut Pasteur de Madagascar

Registry information

Official study 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)

Acronym: MALINEA

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 22, 2018
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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