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

Primary Purpose

Moderate Acute Malnutrition

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Azythromycin

Inuline and fructo-oligosaccharides

Albendazole

Fortified blend flour

About this trial

This is an interventional treatment trial for Moderate Acute Malnutrition focused on measuring Children, Africa, Metagenomic, Prebiotic, Randomized Controlled Trial, Pragmatic trial, Azithromycin, Cognitive impairment

Eligibility Criteria

6 Months - 24 Months (Child)All SexesAccepts 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.

Sites / Locations

Institut Pasteur de bangui - Centre Nutritionnel de Gbangouma et Centre de Santé Saint-Joseph
Institut Pasteur de Madagascar - CRENAM Andohotapenaka et Centre de Santé Mitia
Centre de santé intégré ACF de Tchake et d'Issawanne
Institut Pasteur de Dakar - Poste de Santé Hamo V

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Control group

Azythromycin

Prebiotic

Arm 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.

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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cognitive-motor development (Senegal)

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

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.

Full Information

NCT ID

NCT03474276

First Posted

June 13, 2016

Last Updated

May 23, 2022

Sponsor

Institut Pasteur

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03474276

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

January 31, 2018 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Pasteur

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate Acute Malnutrition

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1357 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Arm Title

Azythromycin

Arm Type

Active Comparator

Arm Description

Arm Title

Prebiotic

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Azythromycin

Other Intervention Name(s)

Antibiotics

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Inuline and fructo-oligosaccharides

Other Intervention Name(s)

Prebiotic

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Albendazole

Other Intervention Name(s)

Antiparasitic drug

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Fortified blend flour

Other Intervention Name(s)

Lacteal flour

Intervention Description

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

Primary Outcome Measure Information:

Title

Recovery at three month

Description

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

Time Frame

Three month

Secondary Outcome Measure Information:

Title

Cognitive-motor development (Senegal)

Description

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

Time Frame

Baseline, three, six and nine months after inclusion

Title

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

Description

Time Frame

Baseline, three and six months after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronan JAMBOU, PhD

Organizational Affiliation

Institut Pasteur

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Muriel Vray, phD

Organizational Affiliation

Institut Pasteur

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bangui

ZIP/Postal Code

BP 923

Country

Central African Republic

Facility Name

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

City

Antananarivo

ZIP/Postal Code

101

Country

Madagascar

Facility Name

Centre de santé intégré ACF de Tchake et d'Issawanne

City

Maradi

Country

Niger

Facility Name

Institut Pasteur de Dakar - Poste de Santé Hamo V

City

Dakar

State/Province

Guédiawaye

Country

Senegal

12. IPD Sharing Statement

Citations:

PubMed Identifier

30514364

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. Erratum In: Trials. 2019 Apr 11;20(1):211.

Results Reference

derived

Links:

URL

http://www.gret.org/

Description

GRET: French development NGO fighting poverty and inequalities, providing solutions for development [150 projects per year in 30 countries]

URL

http://www.pasteur.fr/en

Description

Institut Pasteur: Private non-profit foundation whose mission is to prevent and treat diseases through research, teaching, and public health initiatives.

URL

http://www.actionagainsthunger.org

Description

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

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

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