Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis
MoHuM-1
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2013
CompletedFirst Submitted
Initial submission to the registry
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJune 13, 2025
June 1, 2025
2.9 years
April 10, 2013
June 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline at w12 and w24 in fecal calprotectin levels
Baseline, week 12 change from baseline, week 24 change from week 12
Baseline, week 12, week 24
Change from baseline at w12 and w24 in pulmonary calprotectin levels
Baseline, week 12 change from baseline, week 24 change from week 12
Baseline, w12, w24
Study Arms (2)
Placebo
PLACEBO COMPARATORplacebo once daily for 12 weeks
Lactobacillus rhamnosus
EXPERIMENTALlactobacillus rhamnosus once daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- moderate to severe CF disease
You may not qualify if:
- chronic disease other than CF (except CF associated disorders)
- any probiotic intake
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cantonal Hospital of St. Gallenlead
- Swiss Federal Institute of Technologycollaborator
- Insel Gruppe AG, University Hospital Berncollaborator
Study Sites (1)
Childrens's Hospital of Eastern Switzerland
Sankt Gallen, Canton of St. Gallen, 9008, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Pediatric Infectious Diseases
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 23, 2013
Study Start
February 22, 2013
Primary Completion
December 31, 2015
Study Completion
December 31, 2018
Last Updated
June 13, 2025
Record last verified: 2025-06