Moderate Acute MalnutritionPhase 3MALINEANCT03474276
Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old
A Phase 3 study testing Azythromycin, Inuline and fructo-oligosaccharides and Albendazole in people with Moderate Acute Malnutrition, run by Institut Pasteur at 4 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Moderate Acute Malnutrition
- What is being tested?
- Azythromycin, Inuline and fructo-oligosaccharides and Albendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,357 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 31 Jan 2018to 30 Jun 2019
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Central African Republic1 site
Institut Pasteur de bangui - Centre Nutritionnel de Gbangouma et Centre de Santé Saint-Joseph
Bangui, BP 923
Madagascar1 site
Institut Pasteur de Madagascar - CRENAM Andohotapenaka et Centre de Santé Mitia
Antananarivo, 101
Senegal1 site
Institut Pasteur de Dakar - Poste de Santé Hamo V
Dakar, Guédiawaye
About this study
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)
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.
Read the 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.
- Conditions
- Moderate Acute Malnutrition
- Being tested
- Azythromycin, Inuline and fructo-oligosaccharides, Albendazole, Fortified blend flour
- Keywords
- Children, Africa, Metagenomic, Prebiotic, Randomized Controlled Trial, Pragmatic trial, Azithromycin, Cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzythromycinDrug
Also called Antibiotics
Administration of azythromycin to the child at inclusion (3 days) 20 mgs/kgs/day : three days
Inuline and fructo-oligosaccharidesDietary supplement
Also called Prebiotic
Administration of inuline and fructo-oligosaccharides (Synergy1) 2g/day, mixed with the fortified blend flour given to the child through the whole intervention.
AlbendazoleDrug
Also called Antiparasitic drug
Administration of Albendazole at inclusion of the child : 200mgs, one administration
Fortified blend flourDietary supplement
Also called Lacteal 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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) Receives: Dietary Supplement: Inuline and fructo-oligosaccharides; Drug: Albendazole; Dietary Supplement: Fortified blend flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three month
Secondary outcomes (2)
Cognitive-motor development (Senegal)
Developmental Milestones Checklist II (DMC II) questionnaire to evaluate participating children cognitive and motor abilities.
Measured: Baseline, three, six and nine months after inclusion
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.
Measured: Baseline, three and six months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start31 Jan 2018
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate Acute MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Ronan JAMBOU, PhD, Principal investigator, Institut PasteurMuriel Vray, phD, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474276
- Sponsor's protocol ID
- 2014-062
- Other IDs
- FPC N° 2013-4025
- Acronym
- MALINEA
- Status last verified
- May 2022
- First submitted
- 13 Jun 2016
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30514364