Indrio 2014.
| Methods |
Study design: prospective, multi‐centre, double‐blind, placebo‐controlled, randomised clinical trial Unit: 9 paediatric units Location: Italy Setting: outpatients |
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| Participants |
Sample size: 554 neonates Number of dropouts/withdrawals: 86 (38 = intervention; 48 = control) Age: 39 weeks' gestational age Inclusion criteria: gestational age > 37 to < 41 weeks, age < 1 weeks on entry into the study, birth weight adequate for gestational age, APGAR score > 10 at 10 minutes, no congenital disorders or clinical or physical alterations at clinical examination, and no antibiotic or probiotic administration before inclusion Exclusion criteria: those not meeting the above inclusion criteria |
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| Interventions |
Intervention (n = 238): 5 drops/day of L reuteri DSM 17938 at dose of 1 × 108 CFU/day, suspended in oil in a bottle with a dropper cap, given to neonates every day for 90 days Control (n = 230): identical formulation of oils supplied in an identical bottle Duration of intervention: 90 days |
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| Outcomes |
Primary outcomes: reduction of daily crying time, regurgitation and constipation during the first 3 months of life Secondary outcomes: cost–benefit analysis of the probiotic supplementation with number of primary paediatrician visits; feeding changes; hospitalisations; access to a paediatric emergency department; loss of parental working days; and use of simethicone, cimetropium bromide and natural or herbal products to control gastrointestinal symptoms Timings of measurements: 3 months |
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| Notes |
Study start date: September 2010 Study end date: October 2012 Declared DOI: none Perceived DOI: none Funding source: supported by BioGaia, who make the product used in the study. Clinical trials record:NCT01235884 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "an independent statistician generated the random allocation sequence." |
| Allocation concealment (selection bias) | Low risk | Comment: not mentioned. We contacted the study author, through the interventional agent supplier, who confirmed central allocation concealment. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the study personnel, health care workers, and parents were masked to the study group allocation." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Parents and investigators were masked to the intervention." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: none noted |
| Selective reporting (reporting bias) | Low risk | Comment: none noted |
| Other bias | High risk | Comment: supported by BioGaia who make the product. |