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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT05803993
Eligibility Criteria:
Inclusion Criteria:
* Ability to express and give informed consent
* Age ≥ 18 years
* Diagnosis of constipation-predominant or with mixed/alternating stool pattern IBS, according to the Rome IV criteria
* Have performed a colonoscopy within the last 5 years that has ruled out intestinal diseases
Exclusion Criteria:
* Taking antibiotics or probiotics within the 8 weeks before the baseline visit
* Patients with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis or eosinophilic gastroenteritis), malignant neoplasms of the gastroenteric tract, celiac disease, diverticular disease
* Uncontrolled heart failure or severe heart disease with EF \< 30%
* Severe respiratory failure
* Serious psychiatric conditions or psychological instability according to the clinician
* Contraindication to fecal microbiota transplantation (high risk of complications related to colonoscopy)
* Previous abdominal surgery on the gastroenteric tract (except cholecystectomy, appendectomy and other types of surgery not involving the digestive tract)
* Patients with cutaneous enterostomy
* Pregnancy or lactation
* Concurrent enrollment in other interventional experimental protocols
* Personality unstable or unable to adhere to protocol procedures
* Any clinical condition which, in the opinion of the investigators, may contraindicate enrollment in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05803993
Study Brief:
Protocol Section:
NCT05803993