MedTrace Logo

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

NCT06284577 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-06-13

No results posted yet for this study

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.

Conditions

  • Cystic Fibrosis in Children

Interventions

DIETARY_SUPPLEMENT

Multistrain Probiotic

Participants will recieve a multi-strain probiotic daily for 6 months

DIETARY_SUPPLEMENT

Placebo - maltodextrin

Participants will recieve placebo/ maltodextri daily for 6 months

Sponsors & Collaborators

  • Norwegian National Advisory Unit on Rare Disorders, Oslo University Hospital

    collaborator UNKNOWN

  • Oslo University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2027-06-01
Completion
2027-07-01

Countries

  • Norway

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06284577 on ClinicalTrials.gov