Probiotics in cystic fibrosis patients: A double blind crossover placebo controlled study: Pilot study from the ESPGHAN Working Group on Pancreas/CF

Clin Nutr ESPEN. 2018 Oct:27:59-65. doi: 10.1016/j.clnesp.2018.06.008. Epub 2018 Jul 20.

Abstract

Background: A potential positive effect of probiotics in cystic fibrosis (CF) on fecal calprotectin (FCP), pulmonary exacerbations and weight has been described in small controlled trials.

Methods: A double-blind multicenter cross-over study (2 × 4 m) was performed looking at abdominal pain, nutritional status, pulmonary function, pulmonary exacerbation, 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.

Results: 31 CF patients entered the study of which 25 finished it. At start patients aged 9.3yrs (6.9-12.2), had a median BMI z-score of -0.5 (-1.5-0.08), height z-score of -0.4 (-1.1-0.05) and FEV1% of 100% (87.2-106.6). Median FCP at start was 61 μg/g (17-108) and gut permeability 0.079 (0.051-0.122). 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 z-score (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.

Conclusion: Normalization of gut permeability was observed in 13% of patients during probiotic treatment. However, none of the previously described effects could be confirmed.

Keywords: Cystic fibrosis; Microbiome; Probiotics.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Abdominal Pain / diet therapy
  • Abdominal Pain / microbiology*
  • Child
  • Cross-Over Studies
  • Cystic Fibrosis / complications
  • Cystic Fibrosis / microbiology*
  • Cystic Fibrosis / physiopathology
  • Double-Blind Method
  • Feces / microbiology*
  • Female
  • Gastrointestinal Microbiome
  • Humans
  • Leukocyte L1 Antigen Complex / metabolism*
  • Male
  • Pilot Projects
  • Probiotics / therapeutic use*
  • Treatment Outcome

Substances

  • Leukocyte L1 Antigen Complex