Actively Recruiting
Probiotic Supplementation, Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis
Led by Oslo University Hospital · Updated on 2024-06-13
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
N
Norwegian National Adivisory Unit on Rare Disorders
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying children with cystic fibrosis (CF) to see how probiotic supplements might improve their gut-related quality of life. The study also explores how probiotics and a new CF treatment called elexacaftor-tezacaftor-ivacaftor (ETI) affect gut bacteria and intestinal inflammation. This research aims to enhance quality of life and reduce gastrointestinal problems in pediatric CF patients. The project includes two parts: an observational study and a randomized placebo-controlled trial. In the trial, children aged 3 to 18 years will be randomly assigned to receive either a multi-strain probiotic or a placebo (maltodextrin) daily for six months. The study will compare changes in gut health and inflammation before and after starting the ETI treatment and probiotic supplementation. Participants will provide stool samples and complete quality of life questionnaires during routine visits before and after treatment. Researchers will monitor gastrointestinal quality of life using the PedsQL GI questionnaire, analyze changes in gut microbiota and intestinal inflammation, and examine body composition linked to lung function. The study is expected to last from the start of probiotic or placebo treatment through six months of follow-up.
CONDITIONS
Brief Title
Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- CFTR mutations eligible for treatment with elexacaftor-tezacaftor-ivacaftor (ETI)
- Age 2 to 18 years
- Included in the Norwegian CF Register and consented to participation in the CF general research biobank
- For the clinical trial part (WP2): age 3 to 18 years
- CFTR modulator treatment naive or treated for at least 6 months
You will not qualify if you...
- Use of other CFTR modulators started within the last 6 months
- Use of probiotics or prebiotics within the last 2 months
- Current pulmonary exacerbation or lung infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either a multi-strain probiotic or placebo daily to study the effects on gut health and quality of life in children with cystic fibrosis.
Monthly visits during treatment
Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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