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. 2020 Jan 22;2020(1):CD012949. doi: 10.1002/14651858.CD012949.pub2

NCT01201434.

Methods Trial design: RCT.
Trial grouping: cross‐over design.
Randomisation method: not specified.
Participants Inclusion criteria

  • Mild to moderate CF.

  • At least 3 pulmonary exacerbations requiring antibiotics per year.

  • P aeruginosa in the sputum.

  • Able to produce sputum.


Exclusion criteria

  • Severe pulmonary disease.

  • Less than 3 pulmonary exacerbations per year.

  • Unable to produce sputum.


Baseline characteristics
Overall

  • Participants: n = 12 (terminated early).
Interventions Probiotic

  • Preparation: 2.5×1010 CFU/day; L acidophilus, B bifidum, L rhamnosus, L lactis, L casei, B breve, S thermophilus, B longum, L paracasei, L plantarum, B infantis (Bio‐25 probiotic).

  • Dose (probiotic): 2.5×1010 CFU/day (2 tablets).

  • Frequency of administration: daily.

  • Duration: 6 months.


Placebo

  • Preparation: tablet (contents not specified).

  • Dose (probiotic): 0.

  • Frequency of administration: daily.

  • Duration: 6 months.
Outcomes Primary outcome measure

  • Rate of pulmonary exacerbations (requiring IV and oral antibiotic treatment).


Secondary outcome measures

  • Sputum bacteria.

  • Sputum inflammatory markers.

  • Gastrointestinal inflammation.


Time points for measurements: not specified.
Length of follow‐up: not specified.
Identification Country: Israel.
Setting: Edmond and Lily Safra Children's Hospital, Sheba Medical Center.
Author's name: Dr Batia Weiss.
Institution: Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Israel.
Email: Batya.Vais@sheba.health.gov.il.
Address: Emek Ha’ela 31, Ramat Gan, Israel.
Funding Source Not specified.
Declaration of Interest Among the Primary Researchers Not specified.
Notes Trial was terminated in December 2013 after a severe allergic reaction (severe urticaria) for 1 participant in the probiotic group. 12 participants were enrolled at the time of termination.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information available.
Allocation concealment (selection bias) Unclear risk Insufficient information available.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information available.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information available.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information available.
Selective reporting (reporting bias) Unclear risk Insufficient information available.
Other bias Unclear risk Blinding of outcome assessment (detection bias).