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

Cystic Fibrosis Clinical Trial

— MoHuM-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01837355
• Other study ID #: EKSG 12/129/1B
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2013
• Last updated: April 21, 2018
• Start date: March 2013
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: Cantonal Hospital of St. Gallen
• Contact: Christian Kahlert, MD
• Phone: +41714941111
• Email: christian.kahlert[@]kssg.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Inflammation
• Microbiota
• Pneumonia
• Pulmonary Inflammation

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus

• Placebo

Locations

Country	Name	City	State
Switzerland	Childrens's Hospital of Eastern Switzerland	St. Gallen	SG

Sponsors (3)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen	Swiss Federal Institute of Technology, University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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