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:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT06932666
Eligibility Criteria:
Inclusion Criteria:
* 18-65 years old
* BMI:18.5-29.9 kg/m2
* Self-reported regular defecations defined as at least every second day
* Willing to collect urine and stool samples at home and able to temporarily store them in their own freezer in a provided container
* Willing to exclusively eat the food provided
* Owning a smartphone (iOS 11.0 and onwards, or Android 5.0 and onwards) with access to the internet
* Speak and understand Danish or English
Exclusion Criteria:
* Current pregnancy or lactation
* Following a specific dietary program or diet (e.g., vegetarian, vegan, gluten-free) or unable to consume the food provided
* Diagnosis of small intestinal bacterial overgrowth (SIBO), inflammatory bowel diseases (IBD), gastrointestinal obstruction, or ischemic colitis
* Diagnosed chronic constipation
* Regular use of diarrhea inhibitors or laxatives
* Any chronic disease that can affect the outcomes of the study
* Use of medications potentially altering gastric pH (proton pump inhibitors, histamine receptor antagonists, antacids)
* Use of medications potentially altering the gastro-intestinal motility (prokinetics, antiemetic agents, anticholinergic agents, narcotic analgesics, nonsteroidal anti-inflammatory drugs, peroral glucocorticoids, and GLP-1 related medications such as semaglutide and liraglutide)
* Use of antibiotics, or any medication that can affect any outcomes of the study, within the previous three months
* Concurrent participation in another trial
* Any condition that makes the project responsible and/or the clinical responsible doubt the feasibility of the volunteer's participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06932666
Study Brief:
Protocol Section:
NCT06932666