Investigating the impact of probiotics on gut health and quality of life in children with cystic fibrosis
Probiotic Supplementation, Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis
This study is testing if giving probiotics can improve gut health and quality of life for children with cystic fibrosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06284577 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of probiotic supplementation on gastrointestinal (GI) related quality of life in pediatric patients with cystic fibrosis (CF) through a randomized placebo-controlled trial. It includes two work packages: one observational and one interventional, where participants will be randomized to receive either probiotics or a placebo. The study will also explore the gut microbiota and intestinal inflammation in relation to a new CF treatment, elexacaftor-tezacaftor-ivacaftor (ETI). By assessing these factors, the study seeks to enhance the overall care and management of children with CF.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 2-18 years with cystic fibrosis who are eligible for treatment with ETI.
Not a fit: Patients currently experiencing a pulmonary exacerbation or those who have recently used other CFTR modulators or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and reduce gastrointestinal issues in children with cystic fibrosis.
How similar studies have performed: Other studies have shown promising results with probiotic supplementation in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for WP1: * CFTR mutations eligible for treatment with ETI * Age 2-18 years. Majority of patients will be 2-6 years of age as ETI was approved from 6 years of age in 2022, and will be available for children above 2 years from 2024. * Included in the Norwegian CF Register and consented to participation in CF general research biobank Exclusion criteria for WP1: * Other CFTR modulators commenced the last 6 months before inclusion * Use of probiotics or prebiotics last 2 months * Current pulmonary exacerbation Inclusion criteria for WP2: * Age 3-18 years * CFTR modulator treatment naïve or treated with CFTR modulator for at least 6 months * Included in the Norwegian CF Register and consented to participation in CF general research biobank Exclusion criteria for WP2: * CFTR modulators commenced the last 6 months before inclusion * Use of probiotics or prebiotics last 2 months * Current pulmonary exacerbation
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.