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

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ClinicalTrials.gov Identifier: NCT01837355
Recruitment Status : Recruiting
First Posted : April 23, 2013
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
Swiss Federal Institute of Technology
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Christian R Kahlert, MD, 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.

Condition or disease Intervention/treatment Phase
Pulmonary Inflammation Cystic Fibrosis Microbiota Dietary Supplement: Lactobacillus rhamnosus Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1)
Study Start Date : March 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
placebo once daily for 12 weeks
Dietary Supplement: Placebo
Experimental: Lactobacillus rhamnosus
lactobacillus rhamnosus once daily for 12 weeks
Dietary Supplement: Lactobacillus rhamnosus



Primary Outcome Measures :
  1. Change from baseline at w12 and w24 in fecal calprotectin levels [ Time Frame: Baseline, week 12, week 24 ]
    Baseline, week 12 change from baseline, week 24 change from week 12

  2. Change from baseline at w12 and w24 in pulmonary calprotectin levels [ Time Frame: Baseline, w12, w24 ]
    Baseline, week 12 change from baseline, week 24 change from week 12



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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837355


Contacts
Contact: Christian Kahlert, MD +41714941111 christian.kahlert@kssg.ch
Contact: Pascal Müller, MD +4142437111 pascal.mueller@kispisg.ch

Locations
Switzerland
Childrens's Hospital of Eastern Switzerland Recruiting
St. Gallen, SG, Switzerland, 9008
Contact: Pascal Müller, MD    +41712437111    pascal.mueller@kispisg.ch   
Contact: Christian Kahlert, MD    +41714941111    christian.kahlert@kssg.ch   
Principal Investigator: Pascal Müller, MD         
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Swiss Federal Institute of Technology
University Hospital Inselspital, Berne

Responsible Party: Christian R Kahlert, MD, Consultant Pediatric Infectious Diseases, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01837355     History of Changes
Other Study ID Numbers: EKSG 12/129/1B
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Fibrosis
Inflammation
Cystic Fibrosis
Pneumonia
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Respiratory Tract Infections