Probiotics and the EARly Life effects on intestinal bacteria and inflammation in children with Cystic Fibrosis (PEARL-CF”)

Not Applicable

Recruiting

• Conditions: Cystic fibrosis; Human Genetics and Inherited Disorders - Cystic fibrosis; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12616000797471
• Lead Sponsor: Sydney Children's Hospitals Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

(1) All subjects with CF must fulfil the diagnostic criteria for CF (sweat chloride greater or equal to 60 mmol/L and/or 2 CF-causing mutations).

(2) Healthy controls include healthy full term infants (38-40 weeks gestation; >2.5kg birth weight), and who do not have any major non-CF disease (e.g. spina bifida) or gut disease (e.g. inflammatory bowel disease).

Exclusion Criteria

1) Patients with CF who have had previous intestinal surgery (e.g. meconium ileus) and/or have intestinal resection resulting in short gut syndrome.
(2) Any CF subject already on probiotics but who are not willing to stop supplementation for 3 months prior to randomization.
(3) Healthy controls on probiotics who are not willing to stop.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcomes: Intestinal microbial profiles from stool samples will be measured by: <br>(i)Microbial richness expressed by the total number of operational taxonomic units at a species level[Baseline and 2 monthly for the first 12 months, and then 3 monthly for the next 12 months. ];Primary outcomes: Intestinal microbial profiles from stool samples will be measured by: <br>(ii)Microbial diversity using Shannon’s diversity index<br>[Baseline and 2 monthly for the first 12 months, and then 3 monthly for the next 12 months. ];Primary outcomes: Intestinal microbial profiles from stool samples will be measured by: <br>(iii)Bray-Curtis dissimilarity<br>[Baseline and 2 monthly for the first 12 months, and then 3 monthly for the next 12 months. ]