Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis

Cantonal Hospital of St. Gallen68 enrolled

Overview

Pulmonary inflammation is an independent risk factor for disease progression in cystic fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several inflammatory diseases. As children with CF have different faecal microbiota from their healthy siblings, modulating gut microbiota by lactobacillus rhamnosus diet supplementation might be a strategy to target the inflammatory state in CF. Study subjects (CF or healthy control) will receive either placebo or lactobacillus rhamnosus once daily as dietary supplementation for 12 weeks. After a one-week washout phase, they will be switched for another 12 weeks to the other trial arm. Effect on in intestinal and pulmonary inflammation as well as clinical outcome will be studied.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pulmonary Inflammation Cystic Fibrosis Microbiota

Eligibility

Sex: ALLMin age: 6 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * moderate to severe CF disease Exclusion Criteria: * acute gastroenteritis 2 weeks prior to inclusion * chronic disease other than CF (except CF associated disorders) * oral or parenteral antibiotics 2 weeks prior to inclusion * systemic steroids 4 weeks prior to inclusion * any probiotic intake

Outcomes

Primary Outcomes

Change from baseline at w12 and w24 in fecal calprotectin levels

Baseline, week 12 change from baseline, week 24 change from week 12

Time frame: Baseline, week 12, week 24

Change from baseline at w12 and w24 in pulmonary calprotectin levels