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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00745004
Eligibility Criteria:
Inclusion Criteria:
* IBS-D patients meeting the Rome III criteria.
* Male or female aged 18-75 years
* Women of child bearing potential (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study., (e.g. implants, injectables, combined oral contraceptives, sexual abstinence or vasectomised partners)
* Patients who are able to give informed consent.
Exclusion Criteria:
* Women who are pregnant or breastfeeding
* Patients that, in the opinion of the investigator, are considered unsuitable.
* Patients who have had abdominal surgery which may cause bowel symptoms similar to IBS (Please note, appendicectomy and cholecystectomy is not an exclusion)
* Patient unable to stop anti-diarrhoeal drugs
* Patients currently participating in another clinical trial or who have been in a trial in the previous three months
Since many patients will be on SSRIs or tricyclics antidepressants these will not be an exclusion criteria, provided they have been on medication at least 3 months and that the dose remains unaltered throughout the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00745004
Study Brief:
Protocol Section:
NCT00745004