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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004940-31-DK

Enrollment

Registered

2020-03-24

Start date

2020-03-24

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GI pains and fat malabsorption in cystic fibrosis patients with pancreas insufficiency MedDRA version: 20.1 Level: LLT Classification code 10025479 Term: Malabsorption syndrome System Organ Class: 100000004856

Interventions

Trade Name: Creon 10.000, hårde enterokapsler Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pankreatin CAS Number: 8049-47-6 Other descriptive name: PANCREATIN Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: It is explored whether the timing of intake of enzyme replacement therapy (Creon®) in relation to the meal has impact on the effect on GI pains and fat excretion in cystic fibrosis patients with 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: Evaluated by patient at baseline and then compared to evaluation by patient after each intervention period every fourth week, in a total intervention period of 12 weeks.	—

Measure

Time frame

Main Objective: It is explored whether the timing of intake of enzyme replacement therapy (Creon®) in relation to the meal has impact on the effect on GI pains and fat excretion in cystic fibrosis patients with 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: Evaluated by patient at baseline and then compared to evaluation by patient after each intervention period every fourth week, in a total intervention period of 12 weeks.

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Secondary

Measure	Time frame
Secondary end point(s): - 24 hour excretion of fat in feces in grams measured as average of 1 day of collection. - QoL. - Feces consistency evaluated by patient using Bristol scale. - Abdominal circumference. - 24 hour dietary interview. - Weight. - BMI.;Timepoint(s) of evaluation of this end point: - 24 hour excretion of fat in feces in grams measured as average of 1 day of collection: After each intervention period, every fourth week. - QoL: At baseline and after each intervention period, every fourth week. - Feces consistency evaluated by patient: At baseline and after each intervention period, every fourth week. - Abdominal circumference: At baseline and after each intervention period, every fourth week. - 24 hour dietary interview: At baseline and after each intervention period, every fourth week. - Weight: At baseline and after each intervention period, every fourth week. - BMI: At baseline and after each intervention period, every fourth week.	—

Measure

Time frame

Secondary end point(s): - 24 hour excretion of fat in feces in grams measured as average of 1 day of collection. - QoL. - Feces consistency evaluated by patient using Bristol scale. - Abdominal circumference. - 24 hour dietary interview. - Weight. - BMI.;Timepoint(s) of evaluation of this end point: - 24 hour excretion of fat in feces in grams measured as average of 1 day of collection: After each intervention period, every fourth week. - QoL: At baseline and after each intervention period, every fourth week. - Feces consistency evaluated by patient: At baseline and after each intervention period, every fourth week. - Abdominal circumference: At baseline and after each intervention period, every fourth week. - 24 hour dietary interview: At baseline and after each intervention period, every fourth week. - Weight: At baseline and after each intervention period, every fourth week. - BMI: At baseline and after each intervention period, every fourth week.

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Countries

Denmark

Contacts

Public ContactDepartment of Infectious Diseases

Rigshospitalet

terese.katzenstein@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026