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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cystic Fibrosis; Microbiota; Pulmonary Inflammation
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lactobacillus rhamnosus

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • SG
    • St. Gallen, SG, Switzerland, 9008
      • Childrens's Hospital of Eastern Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Collaborators: Swiss Federal Institute of Technology; Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2013
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (Estimated): April 23, 2013

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Pneumonia; Inflammation; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: EKSG 12/129/1B