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NCT06284577

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

Recruiting now NA Last updated 13 June 2024
What this trial tests

NA trial testing Multistrain Probiotic in Cystic Fibrosis in Children in 40 participants. Currently enrolling.

Timeline
2 January 2024
Primary endpoint
1 June 2027
1 July 2027

Quick facts

Lead sponsorOslo University Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment40
Start date2 January 2024
Primary completion1 June 2027
Estimated completion1 July 2027
Sites1 location across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Oslo University Hospital

Who can join

Adults 2 to 18, any sex, with Cystic Fibrosis in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Multistrain Probiotic

Trials testing the same drug.

Other recruiting trials for Cystic Fibrosis in Children

Currently open trials in the same condition.

Other Oslo University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing