CFDB - Cystic Fibrosis DataBase

Cochrane Database of Systematic Reviews - Cochrane Protocol (ongoing review)

Prebiotics for people with cystic fibrosis

Study design (if review, criteria of inclusion for studies)

Trials using both single and combined fibre‐prebiotic interventions of inulin, FOS and GOS. Authors will exclude candidate fibre prebiotics of resistant starch, polydextrose, xylo‐oligosaccharide, imalto‐oligosaccharide and isomalto‐oligosaccharide due to the lack of evidence to accepted them as qualified prebiotics; candidate non‐fibre prebiotics polyphenolics, and polyunsaturated fatty acids. We will exclude in vitro trials or trials examining the effect of probiotics alone or synbiotics (without adequate description on dose of prebiotic and type of prebiotic used).

Participants

Children and adults with CF, who fulfil consensus diagnostic criteria for CF (Farrell 2017). No restrictions for participants in terms of age, gender, genotype, pancreatic exocrine sufficiency status, disease severity, comorbidities, antibiotic use or CFTR modulator therapy.

Interventions

Prebiotics, defined as "a substrate that is selectively utilised by host microorganisms conferring a health benefit". Authors will compare any oral fibre‐prebiotic (inulin, FOS and GOS, dose or formulation, without a probiotic) to any other prebiotic formulation, probiotic or synbiotic, or placebo or no control treatment. Soluble fibre‐prebiotic inulin, fructo‐oligosaccharides (FOS), and galacto‐oligosaccharides (GOS) and human milk oligosaccharides (HMOs).

Outcome measures

Primary outcomes: 1) Growth and nutrition (mean change from baseline and post‐treatment absolute mean): height, weight, BMI. 2) GI symptoms measured using the multimodal questionnaire for the assessment of abdominal symptoms in people with cystic fibrosis (CFAbd Score). 3) Adverse events. Secondary outcomes. Secondary outcomes: pulmonary exacerbations, lung function (mean change from baseline and post‐treatment absolute mean), inflammatory biomarkers, hospitalisations (all causes), Health‐related quality of life (HRQoL) measured using a validated questionnaire (e.g. Cystic Fibrosis Questionnaire – Revised (CFQ‐R); Quittner 2009).

Keywords: Inulin; Prebiotics; Immunoregulatory; pharmacological_intervention;