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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-22

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Lactobacillus Reuteri in Cystic Fibrosis

NCT01737983

CYSTIC FIBROSIS

COMPLETED PHASE4

Probiotics on Intestinal Inflammation in Cystic Fibrosis

NCT01961661

Cystic Fibrosis

COMPLETED PHASE3

Probiotics in Cystic Fibrosis

NCT01956916

Cystic Fibrosis

COMPLETED PHASE3

Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis

NCT06284577

Cystic Fibrosis in Children

RECRUITING NA

Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis

NCT01201434

Cystic Fibrosis

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Inflammation Cystic Fibrosis Microbiota

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

placebo once daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus rhamnosus

lactobacillus rhamnosus once daily for 12 weeks

Group Type EXPERIMENTAL

Lactobacillus rhamnosus

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus rhamnosus

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes