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New treatment option for Cystic Fibrosis in Children
Official title Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis
ClinicalTrials.gov ID: NCT06284577
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- 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...
- Included in the Norwegian CF Register and consented to participation in CF general research biobank
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.