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

Not Applicable

• Conditions: Pulmonary Inflammation; Cystic Fibrosis; Microbiota
• Interventions: Dietary Supplement: Lactobacillus rhamnosus; Dietary Supplement: Placebo

• Registration Number: NCT01837355
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-23
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-21
• Last Update Posted: 2018-04-24
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lactobacillus rhamnosus	Lactobacillus rhamnosus	lactobacillus rhamnosus once daily for 12 weeks
Placebo	Placebo	placebo once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline at w12 and w24 in pulmonary calprotectin levels	Baseline, w12, w24	Baseline, week 12 change from baseline, week 24 change from week 12
Change from baseline at w12 and w24 in fecal calprotectin levels	Baseline, week 12, week 24	Baseline, week 12 change from baseline, week 24 change from week 12

Trial Locations

Locations (1)

Childrens's Hospital of Eastern Switzerland; 🇨🇭 St. Gallen, SG, Switzerland