Trial reportEuropean journal of pediatrics2024
A synbiotic mixture for the management of infantile colic: A randomized trial.
Trial report in European journal of pediatrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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
1 citing paper in PubMed.
- Infantile Colic: When to Suspect Cow's Milk Allergy.Nutrients · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Infant colic is defined as a recurrent and prolonged period of fussing, crying and/or irritability that cannot be prevented or resolved by caregivers. The aim of this study is to evaluate the efficacy of a synbiotic (Bactecal D Liquid) in infants consulting a primary health care professional for inconsolable crying. A randomized trial was conducted in 68 infants diagnosed by the consulted primary health care professional as "probably suffering from infant colic". Patients were randomized into two groups and given the synbiotic once (group 1) or twice (group 2) a day for 28 days. Quality of life (QoL) of the caregivers, evaluated with a Likert scale, was the primary outcome. Secondary outcomes included the total number of crying episodes, total crying time, gassiness and "balling of the fists". The median (Q1;Q3) QoL scores were significantly (p < 0.001) higher on day 28 than at baseline: 6 (5;7) vs 2 (1;3). At baseline, there was no significant difference (p = 0.527) in QoL between both groups. The improvement in QoL was already significant after one week of intervention for both groups. The median number of crying episodes, overall crying time, gassiness and "balling of fists" were significantly lower on day 28 compared to baseline (p < 0.001).
conclusionThe synbiotic tested was shown to be efficacious in the management of infant colic. A significant improvement was observed after 7 days of intervention, which is much earlier than the expected decrease related to the natural evolution of infant colic. WHAT IS KNOWN: • Some probiotic strains are reported to be effective in the management of infants presenting with colic, if breastfed. WHAT IS NEW: • The synbiotic studied improved quality of life of caregivers of infants presenting infant colic. • Two doses of the synbiotic were not more effective than one dose. • The improved occurred within one week. • The improvement was independent of feeding (breastfeeding, formula feeding or mixed feeding).
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