Pulmonary InflammationMoHuM-1NCT01837355
Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis
A study testing Lactobacillus rhamnosus in people with Pulmonary Inflammation and Cystic Fibrosis, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Inflammation, Cystic Fibrosis, Microbiota
- What is being tested?
- Lactobacillus rhamnosus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Feb 2013to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- moderate to severe CF disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Childrens's Hospital of Eastern Switzerland
Sankt Gallen, Canton of St. Gallen, 9008
About this study
Official title: 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.
- Conditions
- Pulmonary Inflammation, Cystic Fibrosis, Microbiota
- Being tested
- Lactobacillus rhamnosus, Placebo
- Medical subject headings
- Pneumonia, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosusDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo once daily for 12 weeks Receives: Dietary Supplement: Placebo |
| Lactobacillus rhamnosus | Experimental | lactobacillus rhamnosus once daily for 12 weeks Receives: Dietary Supplement: Lactobacillus rhamnosus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at w12 and w24 in fecal calprotectin levels
Baseline, week 12 change from baseline, week 24 change from week 12
Measured: 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
Measured: Baseline, w12, w24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study start22 Feb 2013
- Primary completion31 Dec 2015
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Insel Gruppe AG, University Hospital Bern
- Responsible party
- Principal investigator, Christian R Kahlert, MD, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837355
- Sponsor's protocol ID
- EKSG 12/129/1B
- Acronym
- MoHuM-1
- Status last verified
- Jun 2025
- First submitted
- 10 Apr 2013
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1)
- ClinicalTrials.gov ID
- NCT01837355
- Acronym / sponsor ID
- MoHuM-1 / EKSG 12/129/1B
- Conditions
- Pulmonary Inflammation, Cystic Fibrosis, Microbiota
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Insel Gruppe AG, University Hospital Bern
- Study start
- 22 Feb 2013 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo once daily for 12 weeks |
| Lactobacillus rhamnosus | Experimental | Dietary Supplement: Lactobacillus rhamnosuslactobacillus rhamnosus once daily for 12 weeks |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- moderate to severe CF disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus rhamnosus | Dietary supplement | Lactobacillus rhamnosus |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus in people with Pulmonary Inflammation and Cystic Fibrosis, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline at w12 and w24 in fecal calprotectin levels (time frame: Baseline, week 12, week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.