Trial reportActa paediatrica (Oslo, Norway : 1992)2017
Randomised controlled trial demonstrates that fermented infant formula with short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides reduces the incidence of infantile colic.
Trial report in Acta paediatrica (Oslo, Norway : 1992), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 86 citations in OpenAlex.
- Safety and efficacy of adding postbiotics in infant formula: a systematic review and meta-analysis.Pediatric research · 2024Pooled it
- Dietary modifications for infantile colic.The Cochrane database of systematic reviews · 2018Pooled it
- Early-life fecal microbiome and metabolome dynamics in response to an intervention with infant formula containing specific prebiotics and postbiotics.American journal of physiology. Gastrointestinal and liver physiology · 2022Trial
- Safety and Tolerance of a Novel Anti-Regurgitation Formula: A Double-Blind, Randomized, Controlled Trial.Journal of pediatric gastroenterology and nutrition · 2021Trial
- Trial
- Trial
- Trial
- Why do babies cry? Exploring the role of the gut microbiota in infantile colic, constipation, and cramps in the KOALA birth cohort study.Gut microbes · 2025Article
- Supplementation of 2'-Fucosyllactose in Formula-Fed Infants Has Potential Benefits to Reduce the Risks of Infantile Colic and Atopic Dermatitis in Infancy.Pediatric gastroenterology, hepatology & nutrition · 2025Article
- Review
- Postbiotics as Metabolites and Their Biotherapeutic Potential.International journal of molecular sciences · 2024Review
- Digestive Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Prebiotics and Postbiotics: A Real-World Study.Pediatric gastroenterology, hepatology & nutrition · 2023Article
- Effectiveness of a starch thickened infant formula with reduced lactose content, probiotics and prebiotics on quality of life and clinical outcome in infants with regurgitation and/or colic.Frontiers in nutrition · 2023Article
- Infant feeding practice and gastrointestinal tolerance: a real-world, multi-country, cross-sectional observational study.BMC pediatrics · 2022Observational
- Term Infant Formulas Influencing Gut Microbiota: An Overview.Nutrients · 2021Review
- An Observational Real-Life Study with a New Infant Formula in Infants with Functional Gastro-Intestinal Disorders.Nutrients · 2021Observational
- Nutritional Aspects of Pediatric Gastrointestinal Diseases.Nutrients · 2021Review
- Machine Learning Supports Automated Digital Image Scoring of Stool Consistency in Diapers.Journal of pediatric gastroenterology and nutrition · 2021Article
- Prescription of acid inhibitors in infants: an addiction hard to break.European journal of pediatrics · 2020Article
- The Bifidogenic Effect Revisited-Ecology and Health Perspectives of Bifidobacterial Colonization in Early Life.Microorganisms · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimWe examined the effects on gastrointestinal (GI) tolerance of a novel infant formula that combined specific fermented formula (FERM) with short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS), with a 9:1 ratio and concentration of 0.8 g/100 mL.
methodsThis prospective, double-blind, randomised, controlled trial comprised 432 healthy, term infants aged 0-28 days whose parents decided to not start, or discontinued, breastfeeding. Infant formula with scGOS/lcFOS+50%FERM, scGOS/lcFOS+15%FERM, 50%FERM and scGOS/lcFOS were tested. Parents completed standardised seven-day diaries on GI symptoms, crying, sleeping and stool characteristics each month until the infants were 17 weeks.
resultsAll the formulas were well tolerated. At four weeks, the overall incidence of infantile colic was significantly lower (8%) with scGOS/lcFOS+50%FERM than scGOS/lcFOS (20%, p = 0.034) or 50%FERM (20%, p = 0.036). Longitudinal modelling showed that scGOS/lcFOS+50%FERM-fed infants also displayed a persistently lower daily crying duration and showed a consistent stool-softening effect than infants who received formula without scGOS/lcFOS.
conclusionThe combination of fermented formula with scGOS/lcFOS was well tolerated and showed a lower overall crying time, a lower incidence of infantile colic and a stool-softening effect in healthy term infants. These findings suggest for the first time that a specific infant formula has a preventive effect on infantile colic in formula-fed infants.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.