A Phase 3 interventional study of Azythromycin and Inuline and fructo-oligosaccharides in Moderate Acute Malnutrition, sponsored by Institut Pasteur. Completed at 4 sites in 4 countries. Open to participants aged 6 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by Institut Pasteur · Phase 3, Interventional, and Treatment
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.
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.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Administration of azythromycin to the child at inclusion (3 days) 20 mgs/kgs/day : three days
Also known as: Antibiotics
Drug page: Prebiotics
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
Administration of Albendazole at inclusion of the child : 200mgs, one administration
Also known as: Antiparasitic drug
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
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
Time frame: Three month
Cognitive-motor development (Senegal)
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
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.
Time frame: Baseline, three and six months after inclusion
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Azithromycin · Prebiotics