Actively Recruiting
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
182 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
The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients.
CONDITIONS
Official 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 ETI treatment
- Age between 2 and 18 years
- Included in the Norwegian CF Register and consented to participate in CF general research biobank
- For WP2: Age 3-18 years
- For WP2: Either untreated with CFTR modulators or treated for at least 6 months
You will not qualify if you...
- Started other CFTR modulators within 6 months before joining
- Used probiotics or prebiotics within the last 2 months
- Currently experiencing a pulmonary exacerbation
AI-Screening
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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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