Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT03004118
Eligibility Criteria:
Inclusion Criteria:
Men and women (age 18-60 years) who meet the Rome IV criteria for functional dyspepsia can participate in the study. For 14 weeks, patients need to discontinue their intake of proton pump inhibitors, drugs effecting gastric motility and NSAIDs. If a female participant takes oral anticonception, she has to switch to non-oral anticonception for this study. All participants will receive and sign a copy of the informed consent.
Exclusion Criteria:
* refused informed consent
* pregnant women or women who are breastfeeding
* diabetes mellitus
* celiac disease
* coagulation disorders/anticoagulant therapy
* not well functioning liver and gallbladder
* active stomach or gut ulcer
* biliary colic, calcified gallstones
* acute infection of gallbladder or bile ducts, bile duct obstruction
* intestinal disorders such as ulcerative colitis, Crohn's disease
* lactose intolerance
* allergies/sensitivity (asthma, allergic to bile acids, eczema, allergic rhinoconjunctivitis)
* Intake of oral anticonception, barbiturates, antacid, colestyramine or colestipol, nitrendipine, cyclosporine, ciprofloxacine, rosuvastatine.
* first degree relatives with celiac disease, Crohn's disease or type I diabetes mellitus Severe kidney malfunction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03004118
Study Brief:
Protocol Section:
NCT03004118