Kukkonen 2008.
| Methods |
Study design: randomised, placebo‐controlled, double‐blind trial Unit: none specified Location: Helsinki, Finland Setting: outpatient |
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| Participants |
Sample size: 1018 infants Number of dropouts/withdrawals: not reported but 939 completed the 6‐month follow‐up and 925 completed the 2‐year follow‐up Age: not reported Inclusion criteria: pregnant women carrying children at increased risk of allergy recruited from antenatal clinics Exclusion criteria: < 37 weeks' gestational age, twin baby, major malformation |
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| Interventions |
Intervention (n = 468): pregnant women from 36 weeks took capsules containing a mixture of Lactobacillus rhamnosus GG and LC705, Bifidobacterium breve Bb99 and Propiobibacterium freudenreichii ssp shermanii JS (8–9 × 109 CFUs in each capsule). For 6 months after birth, the infants received 1 opened capsule of the same probiotics and 0.8 g of galacto‐oligosaccharides in liquid form daily Control (n = 471): placebo Duration of intervention: 4 weeks before delivery and 6 months after birth |
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| Outcomes |
Primary outcomes: neonatal morbidity, infantile colic and defecation, feeding‐related behaviours (vomiting, constipation, excessive crying and abdominal discomfort) Secondary outcomes: anthropometric measurement, infection, antibiotics and other disease Timings of measurements: 3, 6, 12 and 24 months |
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| Notes |
Study start date: November 2000 Study end date: March 2003 Declared DOI: none Perceived DOI: none Funding source: Helsinki University Central Hospital Research Funds and Valio Clinical trials record:NCT00298337 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: randomised, double‐blind, placebo‐controlled study with 2 parallel groups and computer‐generated block randomisation at 35 weeks' gestation. |
| Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned. We contacted the study author but received no response. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: none noted |
| Selective reporting (reporting bias) | High risk | Comment: while the manuscript mentioned a primary outcome of colic, it was not explicitly stated in the trial registration record. |
| Other bias | Low risk | Comment: none noted |