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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT03103958
Eligibility Criteria:
Inclusion Criteria:
* Agree to adhere to the procedures and requirements of the study and attend the institute on the day (s) and time (s) determined for the evaluations;
* Being able to consent study participation
* Have one or more complaints of change in bowel habits in the last 3 months with onset of symptoms at least 6 months before diagnosis, as described below:
* Evacuation effort for at least 25% of defecations
* Lumpy stools, on sausage-shaped or hardened in at least 25% of stools, according to the Bristol scale. number 1, 2 or 3;
* Incomplete evacuation count in at least 25% of defecations;
* Feeling of anorectal obstruction / blockage of feces in at least 25% of defecations;
* Manufactured manuals to facilitate at least 25% of stools (for example, evacuation with digital help, pelvic floor support)
Exclusion Criteria:
* Pregnancy or breast-feeding;
* Known intolerance or allergy to any of the study products;
* Previous history of gastrointestinal surgery;
* Patients with celiac disease or inflammatory bowel disease;
* Patients with psychiatric, cardiologic, respiratory, renal and hepatic disease;
* No acceptance of study admission by the participant; Diagnosis of Clostridium difficile diarrhea in the last 3 months;
* Patients with known immunosuppressive disease;
* Any other gastrointestinal pathology;
* Prior use of antibiotics in less than 30 days;
* Frequent use of laxatives or other medication that alters bowel motility (one week without Use before inclusion)
* Regular treatment with probiotics / symbiotic, including regular use of yogurt with probiotics (One week before use before inclusion)
* Regular use of antidepressant, opioid analgesic, antispasmodic or anticholinergic agents
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03103958
Study Brief:
Protocol Section:
NCT03103958