Three‐arm clinical trial of improved flour targeting intestinal microbiota (MALINEA)

• DOI: 10.1111/mcn.13649
• Publication Date: 2024-04-11T01:34:48Z
• Authors: Muriel Vray; Laura Tondeur; Boris G. Hedible; Rindra Vatosoa Ra...; Alexandre Manirakiza; Ramatoulaye Hamid...; Cassandre Van Platen; Antonio Vargas; André Briend; Ronan Jambou
• Keywords: Regimen; Clinical endpoint

Abstract The main objective of this project was to compare in the field conditions two strategies re‐nutrition children with moderate acute malnutrition (MAM) aged from 6 24 months, targeting microbiota comparison a standard regimen. A three‐arm, open‐label, pragmatic randomised trial conducted four countries (Niger, CAR, Senegal and Madagascar). Children received for 12 weeks either fortified blended flour (FBF control) = arm 1, or FBF + azithromycin (oral suspension 20 mg/kg/day daily given syringe) first 3 days at inclusion 2 mix inulin/fructo‐oligosaccharides (6 g/day if age ≥12 months 4 g <12 months) 3. For each arm, 11 100 x per day flours those × FBF. primary endpoint nutritional recovery, defined by reaching weight‐for‐height z‐score (WHZ) ≥ −1.5 within weeks. Overall, 881 were (297, 290 294 3, respectively). Three hundred forty‐four males (39%) median/mean 14.6/14.4 (SD 4.9, IQR 10.5–18.4). At inclusion, three arms comparable all criteria, but differences observed between countries. 44% (390/881) recovered week MAM, no significant difference (41.4%, 45.5% 45.9%, respectively, p 0.47). This study did not support true advantages adding prebiotic antibiotic flour. When using threshold WHZ −2 as an exploratory endpoint, arms, higher success rates antibiotics prebiotics compared control (66.9%, 66.0% 55.2%, 0.005).