Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial

Phase 1

• Conditions: GI pains and fat malabsorption in cysticfibrosis patients with pancreas insufficiency; MedDRA version: 20.1Level: LLTClassification code 10025479Term: Malabsorption syndromeSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-004940-31-DK
• Lead Sponsor: Terese Katzenstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- Outpatient adults of legal age (=18 years)
with cystic fibrosis and pancreatic
insufficiency and who takes enzyme
replacement therapy (Creon®) with every fat
containing meal of the day.
- The patients must be able to physically
attend the planned trial days once a month.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- Acutely ill outpatient and inpatient CF
patients with other disease of impact on
primary outcome (i.e. obstipation that
requires treatment and/or acute lung
exacerbation).
- Pregnancy.
- BMI below 18,5.
- Nonattendance from planned trial days without possibility of rescheduling within a week.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: It is explored whether the timing of intake of<br>enzyme replacement therapy (Creon®) in<br>relation to the meal has impact on the effect<br>on GI pains and fat excretion in cystic fibrosis patients with<br>fat malabsorption.;Secondary Objective: Not applicable.;Primary end point(s): GI pains evaluated by patient using VAS-score.;Timepoint(s) of evaluation of this end point: GI pains evaluated by patient using VAS-score:<br>Evaluated by patient at baseline and<br>then compared to evaluation by patient after<br>each intervention period every fourth week,<br>in a total intervention period of 12 weeks.