Safety and Tolerance of a Novel Anti-Regurgitation Formula
| Autor: | Anne Piollet, Małgorzata Arciszewska, Thomas Ludwig, Yvan Vandenplas, Marc Bellaiche, Anke Bongers, Faouzi Dakhlia, Cédrico Gomes, Raish Oozeer, Agnieszka Świat |
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| Přispěvatelé: | Clinical sciences, Growth and Development, Pediatrics |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
safety
medicine.medical_specialty Vomiting thickened formula gastroesophageal reflux Oligosaccharides Original Articles: Gastroenterology Crying Anti-Regurgitation Formula law.invention Double blind Feces Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Pediatrics Perinatology and Child Health Adverse effect tolerance business.industry Gastroenterology Infant regurgitation functional gastrointestinal disorder Infant Formula Infant formula locust bean gum Pediatrics Perinatology and Child Health Regurgitation (digestion) gastrointestinal (GI) symptoms medicine.symptom Flatulence business |
| Zdroj: | Journal of Pediatric Gastroenterology and Nutrition |
| Popis: | Objectives: A novel anti-regurgitation (AR) formula has been designed to support gut health and improve gastrointestinal (GI) symptoms beyond regurgitation. This study assessed the tolerance and safety of this new AR formula. Methods: This was a 4-week double-blind, randomized, controlled trial with a 4-week extension in formula-fed infants with regurgitation. The new AR (Test) formula contained 0.4 g/100 mL locust bean gum (LBG) as thickener, partly fermented formula with postbiotics, and short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS) (0.4 g/100 mL, ratio 9:1). The Control AR formula contained LBG (0.4 g/100 mL) with postbiotics and has a history of safe use. The primary outcome was the Infant Gastrointestinal Symptom Questionnaire (IGSQ) sum score including stooling, spitting-up/vomiting, crying, fussiness and flatulence. Results: All 182 infants screened were enrolled in the study. The primary analysis showed the equivalence of the IGSQ sum scores at Week 4 between groups. IGSQ sum scores improved significantly within 1 week (Mixed Model Repeated Measurement [MMRM], P |
| Databáze: | OpenAIRE |
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