RecruitingNot ApplicableNCT06284577

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


Sponsor

Oslo University Hospital

Enrollment

40 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 2 YearsMax Age: 18 Years

Inclusion Criteria6

  • 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

Exclusion Criteria6

  • Other CFTR modulators commenced the last 6 months before inclusion
  • Use of probiotics or prebiotics last 2 months
  • Current pulmonary exacerbation
  • CFTR modulators commenced the last 6 months before inclusion
  • Use of probiotics or prebiotics last 2 months
  • Current pulmonary exacerbation

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Interventions

DIETARY_SUPPLEMENTMultistrain Probiotic

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

DIETARY_SUPPLEMENTPlacebo - maltodextrin

Participants will recieve placebo/ maltodextri daily for 6 months


Locations(1)

Oslo University Hospital

Oslo, Norway

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NCT06284577


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