The effect of polyethylene glycol treatment on gut health in Cystic Fibrosis, a pilot study
- Conditions
- Cystic Fibrosis100836241001567410024970
- Registration Number
- NL-OMON48606
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>change in plasma levels of fibroblast growth factor 19 (FGF19) after 2 weeks of<br /><br>laxative treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Changes in subjective parameters related to intestinal health as measured by<br /><br>the corresponding sections of the validated the cystic fibrosis questionnaire<br /><br>(CF-Q), namely gastrointestinal complaints, general wellbeing/condition and<br /><br>treatment burden.<br /><br><br /><br>- Changes in objective parameters related to intestinal health, among which<br /><br>different metabolic processes:<br /><br>Plasma parameters:<br /><br>o Bile acid metabolism: C4, bile acid profile<br /><br>o Glucose metabolism: (fasted) Glucose, HbA1c, insulin<br /><br>o Liver function: GGT, ASAT, ALAT, thrombocytes, albumin<br /><br>o Cholesterol metabolism: lipoprotein profile, triglycerides<br /><br>o Gut health: glucagon-like peptide 1, serotonin (5-HT)<br /><br>- Faecal parameters:<br /><br>o Microbiota composition<br /><br>o Inflammation: calprotectin, lactoferrin, IgA<br /><br>o Elastase<br /><br>o Neutral sterols</p><br>