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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT04899869
Eligibility Criteria:
Inclusion Criteria:
* Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) or Irritable Bowel Syndrome with mixed bowel habits (IBS-M) according to the Rome IV criteria
Exclusion Criteria:
* The use of antibiotics within one month prior to faecal microbiota transplantation
* The use of probiotics within one month prior to faecal microbiota transplantation
* History of inflammatory bowel disease or gastrointestinal malignancy, systemic autoimmune diseases (ongoing or in history)
* Previous abdominal surgery (other than appendectomy or cholecystectomy or hernioplasty or cesarean section)
* HIV infection or other active infection
* Renal or hepatic disease (both defined by biochemistry workup)
* Diabetes mellitus, abnormal thyroid functions not controlled by thyroid medications
* Bipolar disorder or schizophrenia (ongoing or history thereof), moderately severe depression defined by Patient Health Questionnaire-9 (PHQ-9) score \> 15
* Anxiety defined by a Generalised Anxiety Disorder 7 (GAD7) score \> 10
* Current pregnancy and lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04899869
Study Brief:
Protocol Section:
NCT04899869