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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01837355

Acronym

MoHuM-1

Enrollment

Registered

2013-04-23

Start date

2013-02-22

Completion date

2018-12-31

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Inflammation, Cystic Fibrosis, Microbiota

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus rhamnosus

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 20 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline at w12 and w24 in fecal calprotectin levels	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	Baseline, w12, w24	Baseline, week 12 change from baseline, week 24 change from week 12

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026