Effect of omeprazole (gastric acid inhibiting medication) intake on the stool marker of intestinal inflammatio

Phase 1

• Conditions: intestinal inflammation; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2015-003903-51-SE
• Lead Sponsor: inköping university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-01
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

•age 18 – 64 years
•healthy individuals (individuals who are not known to suffer of any significant illness relevant to this study and should be within the ordinary range of body measurements, such as weight, and whose mental state is such that they are able to understand and give valid consent to the study; they should not have any disease or condition requiring regular medication)
•written informed consent signed
•normal faecal calprotectin test, blood count and Helicobacter pylori test
•regular bowel movements
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 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•PPI, NSAID or ASA (acetyl salicylic acid) intake in the past month
•history of regular PPI, NSAID or ASA use
•intolerance to PPIs or NSAIDs
•history of gastrointestinal diseases or bleeding
•conditions associated with bleeding disorders
•asthma, cirrhosis, hepatic porphyria, liver failure, kidney failure, heart failure, ischemic heart disease, peripheral arterial disease and cerebrovascular disease
•pregnancy or lactating
•current alcohol misuse
•participation in another clinical trial involving medicinal products within 30 days

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate how omeprazole intake affects faecal calprotectin levels with and without concurrent coadministration of oral diclofenac and to assess how long it takes for an increased faecal calprotectin to return to normal levels after omeprazole intake with and without concurrent coadministration of oral diclofenac. <br>;Secondary Objective: Not applicable;Primary end point(s): Change in FC level during and after drug administration compared to baseline;Timepoint(s) of evaluation of this end point: Day 0 (the day before start of drug administration), 2, 4, 7, 10 and 14 during drug administration and day 17, 21, 28 and 35 after discontinuation of the drug (± 2 days), then at 7-day intervals (± 2 days) until normalisation of FC.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of participants with level of FC over upper limit of normal reference value;Timepoint(s) of evaluation of this end point: Day 0, 2, 4, 7, 10 and 14 during drug administration and day 17, 21, 28 and 35 after discontinuation of the drug (± 2 days), then at 7-day intervals (± 2 days) until normalisation of FC.