NCT01837355

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

Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Cantonal Hospital of St. Gallen · Academic / Other
• Sex: All
• Age: 6 Years – 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Inflammation
• Cystic Fibrosis
• Microbiota

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus rhamnosus
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2013-02-22
• Primary completion: 2015-12-31
• Completion: 2018-12-31
• First posted: 2013-04-23
• Last updated: 2025-06-13

Locations

1 site across 1 country: Switzerland