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

Primary Purpose

Pulmonary Inflammation, Cystic Fibrosis, Microbiota

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Lactobacillus rhamnosus

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Inflammation

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Childrens's Hospital of Eastern SwitzerlandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Lactobacillus rhamnosus

Arm Description

placebo once daily for 12 weeks

lactobacillus rhamnosus once daily for 12 weeks

Outcomes

Primary Outcome Measures

Change from baseline at w12 and w24 in fecal calprotectin levels

Baseline, week 12 change from baseline, week 24 change from week 12

Change from baseline at w12 and w24 in pulmonary calprotectin levels

Baseline, week 12 change from baseline, week 24 change from week 12

Secondary Outcome Measures

Full Information

NCT ID

NCT01837355

First Posted

April 10, 2013

Last Updated

April 21, 2018

Sponsor

Cantonal Hospital of St. Gallen

Collaborators

Swiss Federal Institute of Technology, Insel Gruppe AG, University Hospital Bern

1. Study Identification

Unique Protocol Identification Number

NCT01837355

Brief Title

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

Acronym

MoHuM-1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cantonal Hospital of St. Gallen

Collaborators

Swiss Federal Institute of Technology, Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Inflammation, Cystic Fibrosis, Microbiota

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo once daily for 12 weeks

Arm Title

Lactobacillus rhamnosus

Arm Type

Experimental

Arm Description

lactobacillus rhamnosus once daily for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus rhamnosus

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change from baseline at w12 and w24 in fecal calprotectin levels

Description

Baseline, week 12 change from baseline, week 24 change from week 12

Time Frame

Baseline, week 12, week 24

Title

Change from baseline at w12 and w24 in pulmonary calprotectin levels

Description

Baseline, week 12 change from baseline, week 24 change from week 12

Time Frame

Baseline, w12, w24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Kahlert, MD

Phone

+41714941111

christian.kahlert@kssg.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Pascal Müller, MD

Phone

+4142437111

pascal.mueller@kispisg.ch

Facility Information:

Facility Name

Childrens's Hospital of Eastern Switzerland

City

St. Gallen

State/Province

ZIP/Postal Code

9008

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal Müller, MD

Phone

+41712437111

pascal.mueller@kispisg.ch

First Name & Middle Initial & Last Name & Degree

Christian Kahlert, MD

Phone

+41714941111

christian.kahlert@kssg.ch

First Name & Middle Initial & Last Name & Degree

Pascal Müller, MD

12. IPD Sharing Statement

Learn more about this trial

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

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