Trial reportNutrition journal2007
The clinical effect of a new infant formula in term infants with constipation: a double-blind, randomized cross-over trial.
Trial report in Nutrition journal, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 6 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, 6 syntheses or guidelines pooled it, 114 citations in OpenAlex.
- Faecal impaction in children aged 0-18 years: a systematic review and metanarrative analysis of definitions used.BMJ paediatrics open · 2025Pooled it
- Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis.Health technology assessment (Winchester, England) · 2024Pooled it
- Pooled it
- Association between funding source, methodological quality and research outcomes in randomized controlled trials of synbiotics, probiotics and prebiotics added to infant formula: a systematic review.BMC medical research methodology · 2013Pooled it
- Prebiotics in infants for prevention of allergy.The Cochrane database of systematic reviews · 2013Pooled it
- Synbiotics, probiotics or prebiotics in infant formula for full term infants: a systematic review.Nutrition journal · 2012Pooled it
- Trial
- Cow's milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCT.Nutrition journal · 2016Trial
- Growth, safety, and tolerance of a hydrolysed rice protein-based formula in infants with cow's milk allergy.Frontiers in nutrition · 2026Article
- A2 β-casein infant formula with high sn-2 palmitate and casein phosphopeptides (CPP) supports energy and mineral absorption in Chinese infants.Frontiers in nutrition · 2026Article
- Microbiota-A Rescuing Modulator in Children Struggling with Functional Constipation.Microorganisms · 2025Review
- Re-evaluation of citric acid esters of mono- and diglycerides of fatty acids (E 472c) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation.EFSA journal. European Food Safety Authority · 2025Article
- Gastrointestinal tolerability of organic infant formula compared to traditional infant formula: A systematic review.World journal of clinical pediatrics · 2024Article
- An A2 β-casein infant formula with high sn-2 palmitate and casein phosphopeptides supports adequate growth, improved stool consistency, and bone strength in healthy, term Chinese infants: a randomized, double-blind, controlled clinical trial.Frontiers in nutrition · 2024Article
- Development and large-scale production of human milk fat analog by fermentation of microalgae.Frontiers in nutrition · 2024Article
- Dietary Fibers in Healthy Children and in Pediatric Gastrointestinal Disorders: A Practical Guide.Nutrients · 2023Review
- Saudi Experts Consensus on Diagnosis and Management of Pediatric Functional Constipation.Pediatric gastroenterology, hepatology & nutrition · 2022Review
- Softer More Frequent Stools in Infants With Difficult Stooling Fed Hydrolyzed Protein Formula With Added Prebiotics: Randomized Controlled Trial.Frontiers in pediatrics · 2022Article
- Review
- An Observational Real-Life Study with a New Infant Formula in Infants with Functional Gastro-Intestinal Disorders.Nutrients · 2021Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNutrilon Omneo (new formula; NF) contains high concentration of sn-2 palmitic acid, a mixture of prebiotic oligosaccharides and partially hydrolyzed whey protein. It is hypothesized that NF positively affects stool characteristics in constipated infants.
methodsThirty-eight constipated infants, aged 3-20 weeks, were included and randomized to NF (n = 20) or a standard formula (SF; n = 18) in period 1 and crossed-over after 3 weeks to treatment period 2. Constipation was defined by at least one of the following symptoms: 1) defecation frequency < 3/week; 2) painful defecation; 3) abdominal or rectal palpable mass.
resultsPeriod 1 was completed by 35 infants. A significant increase in defecation frequency (NF: 3.5 pre versus 5.6/week post treatment; SF 3.6 pre versus 4.9/week post treatment) was found in both groups, but was not significantly different between the two formulas (p = 0.36). Improvement of hard stool consistency to soft stool consistency was found more often with NF than SF, but did not reach statistical significance (90% versus 50%; RR, 1.8; 95% CI, 0.9-3.5; p = 0.14). No difference was found in painful defecation or the presence of an abdominal or rectal mass between the two groups. Twenty-four infants completed period 2. Only stool consistency was significantly different between the two formulas (17% had soft stools on NF and hard stools on SF; no infants had soft stools on SF and hard stools on NF, McNemar test p = 0.046).
conclusionThe addition of a high concentration sn-2 palmitic acid, prebiotic oligosaccharides and partially hydrolyzed whey protein resulted in a strong tendency of softer stools in constipated infants, but not in a difference in defecation frequency. Formula transition to NF may be considered as treatment in constipated infants with hard stools.
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.