NCT06284577Recruiting
Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis
Probiotic Supplementation, Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 13 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 12 Feb 2024
- Start date
- Jan 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- Oslo University Hospital
- Diseases
- Cystic fibrosis
- NCT number
- NCT06284577
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Jan 2024 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other CFTR modulators commenced the last 6 months before inclusion
- CFTR modulators commenced the last 6 months before inclusion
Other
- Use of probiotics or prebiotics last 2 months
- Current pulmonary exacerbation
- Use of probiotics or prebiotics last 2 months
- Current pulmonary exacerbation
Who the study is looking for
- 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
- 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
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.