Cystic Fibrosis
Conditions
Interventions
Polyethylene glycol + electrolytes (Movicolon) 13.8 gram twice daily for 2
weeks
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Cystic fibrosis confirmed by genetic analysis - Exocrine pancreatic insufficiency as reflected by the use of prescribed pancreatic enzyme replacement therapy (usually Creon). - Age of 18 years or above at the time of enrollment in the study
Exclusion criteria
Exclusion criteria: - A current therapeutic antibiotic course for pulmonary exacerbation or need for hospitalization for antibiotic treatment (does not include prophylactic long-term antibiotic use) - Standard prescribed daily treatment with any laxative at the moment of inclusion, because it will be undesirable to stop treatment during the washout period. Occasional treatment with laxatives is not an exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in plasma levels of fibroblast growth factor 19 (FGF19) after 2 weeks of laxative treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in subjective parameters related to intestinal health as measured by the corresponding sections of the validated the cystic fibrosis questionnaire (CF-Q), namely gastrointestinal complaints, general wellbeing/condition and treatment burden. - Changes in objective parameters related to intestinal health, among which different metabolic processes: Plasma parameters: o Bile acid metabolism: C4, bile acid profile o Glucose metabolism: (fasted) Glucose, HbA1c, insulin o Liver function: GGT, ASAT, ALAT, thrombocytes, albumin o Cholesterol metabolism: lipoprotein profile, triglycerides o Gut health: glucagon-like peptide 1, serotonin (5-HT) - Faecal parameters: o Microbiota composition o Inflammation: calprotectin, lactoferrin, IgA o Elastase o Neutral sterols | — |
Countries
Netherlands
Outcome results
None listed