Probiotic Supplementation, Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
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• 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

Locations
Other Locations
Norway
Oslo University Hospital
RECRUITING
Oslo
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 40
Treatments
Experimental: Probiotics
Participants will recieve a multi-strain probiotic daily for 6 months
Sham_comparator: Placebo
Participants will recieve maltodextrin daily for 6 months
Related Therapeutic Areas
Sponsors
Collaborators: Norwegian National Advisory Unit on Rare Disorders, Oslo University Hospital
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov