Study design (if review, criteria of inclusion for studies)
Doubleâblind multicenter crossâover study (2 x 4 m)
Participants
31 CF patients entered the study of which 25 finished it. At start patients aged 9.3yrs (6.9â12.2), had a median BMI zâscore of â0.5 (â1.5â0.08), height zâscore of â0.4 (â1.1â0.05) and FEV1% of 100% (87.2â106.6). Median FCP at start was 61 mug/g (17â108) and gut permeability 0.079 (0.051â0.122).
Interventions
Probiotics
Outcome measures
Abdominal pain, nutritional status, pulmonary function, pulmonary exacerbation, fecal calprotectin (FCP) and lactulose/mannitol gut permeability test. Patients kept a diary with daily scoring of abdominal pain, stool frequency and consistency as well as treatment changes.
Main results
No significant changes were observed in the clinical parameters (BMI, FEV1%, abdominal pain, exacerbations). Despite being frequently abnormal (17/28 (61%) >50 mg/kg), FCP did not change significantly with probiotics. The proportion of patients with normal permeability was 8% during placebo and 32% during probiotic treatment (p = 0.031). FCP correlated to BMI zâscore (p = 0.043) and gut permeability to abdominal pain (p = 0.015). The microbiome revealed a high predominance of Actinobacteria and Proteobacteriae. Probiotic supplementation did not result in a shift at the phylum nor at phylogenetic level.
Authors' conclusions
Normalization of gut permeability was observed in 13% of patients during probiotic treatment. However, none of the previously described effects could be confirmed.