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

NCT03474276 | Completed Phase 3 DMC

• 2 other identifiers: 2014-062FPC N° 2013-4025
• Study Type: interventional
• Target: 1,357
• Locations: 4 countries
• Sites: 4

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.

Conditions

Moderate Acute Malnutrition

Keywords

Children; Africa; Metagenomic; Prebiotic; Randomized Controlled Trial; Pragmatic trial; Azithromycin; Cognitive impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cognitive-motor development (Senegal)

  Baseline, three, six and nine months after inclusion

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

  Baseline, three and six months after inclusion

Study Arms (3)

Control group

ACTIVE COMPARATOR

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.

Drug: Albendazole; Dietary Supplement: Fortified blend flour

Azythromycin

ACTIVE COMPARATOR

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.

Drug: Azythromycin; Drug: Albendazole; Dietary Supplement: Fortified blend flour

Prebiotic

ACTIVE COMPARATOR

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)

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

Interventions

Azythromycin DRUG

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

Also known as: Antibiotics

Azythromycin

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.

Also known as: Prebiotic

Prebiotic

Albendazole DRUG

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

Also known as: Antiparasitic drug

Azythromycin; Control group; Prebiotic

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

Also known as: Lacteal flour

Azythromycin; Control group; Prebiotic

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 followed up during at least three months.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Institut Pasteur de bangui - Centre Nutritionnel de Gbangouma et Centre de Santé Saint-Joseph

Bangui, BP 923, Central African Republic

Location

Institut Pasteur de Madagascar - CRENAM Andohotapenaka et Centre de Santé Mitia

Antananarivo, 101, Madagascar

Location

Centre de santé intégré ACF de Tchake et d'Issawanne

Maradi, Niger

Location

Institut Pasteur de Dakar - Poste de Santé Hamo V

Dakar, Guédiawaye, Senegal

Location

Related Publications (1)

• 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.

  PMID: 30514364 DERIVED

Related Links

• 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.
• Action contre la faim \[Action against hunger\] : International humanitarian organization providing communities with access to safe water and sustainable solutions to hunger.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Azithromycin; Anti-Bacterial Agents; fructooligosaccharide; Prebiotics; Albendazole; Antiparasitic Agents

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ronan JAMBOU, PhD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

• Muriel Vray, phD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: March 22, 2018
• Study Start: January 31, 2018
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

MA (1); CE (1); SE (1); NI (1)