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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The project targets pediatric patients with cystic fibrosis (CF), and has to work packages (WP). WP1 is an observational study, and WP2 is a randomised placebo-controlled clinical trial. The goal of the study is to investigate the effect of probiotics on pediatric CF patients' quality of life (QoL). Moreover the investigators wish to explore effects of both a highly effective CFTR modulator and probiotics on gut microbiota and intestinal inflammation. The primary question it aims to answer are: • Can probiotics improve GI related QoL in children with CF? Secondary aims are to: - Investigate GI microbiota and GI inflammation before and after commencement of the highly effective triple-combination elexacaftor-tezacaftor-ivacaftor (ETI) - Explore GI microbiota before and after treatment with probiotics vs. placebo - Study intestinal inflammation before and after treatment with probiotics vs. placebo - Examine body composition and its relation to lung function In WP1 participants will during routine examination before starting treatment with ETI be asked to deliver stool samples, and fill in QoL questionnaires. In WP2 participants will be randomized to intervention with probiotics or placebo, and the same parameters as in WP1 will also be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06284577
Study type	Interventional
Source	Oslo University Hospital
Contact
Status	Recruiting
Phase	N/A
Start date	January 2, 2024
Completion date	July 1, 2027

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms