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

Cantonal Hospital of St. Gallen

Status: Terminated

Conditions: Cystic Fibrosis; Pulmonary Inflammation; Microbiota

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus rhamnosus

Study type: Interventional

Funder types: Other

Identifiers

NCT01837355

EKSG 12/129/1B

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 6 to 20 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo once daily for 12 weeks

Treatment:

Dietary Supplement: Placebo

Lactobacillus rhamnosus

Experimental group

Description:

lactobacillus rhamnosus once daily for 12 weeks

Treatment:

Dietary Supplement: Lactobacillus rhamnosus