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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00693732
Eligibility Criteria:
Inclusion Criteria:
IBS patients:
* One hundred fifty male and female IBS patients (Rome III criteria), aged 18 to 70 years, recruited from primary and secondary care via advertisements and referral networks.
* Minimum IBS symptom rating of 75 in IBS severity scoring system (IBS-SSS) in last two weeks.
* IBS discomfort or pain must have been patient's most prominent symptom.
* A minimum of 40 patients each IBS-constipated (IBS-C) and IBS-diarrhoeic (IBS-D) (Rome III) to be included.
* Patients must have been off all IBS and analgesic medication and any drugs potentially influencing sensory function for at least two weeks before study start.
Healthy controls:
* Fifteen healthy controls aged 18 to 70 years without any gastrointestinal pathology or history of significant abdominal pain, bowel disorders, bloating or discomfort during the last 3 months.
Exclusion Criteria:
Exclusion criteria for both IBS patients and healthy controls:
* Organic gastrointestinal or other significant systemic disease, including cardiovascular, psychiatric, neurological and endocrine diseases, as judged by investigator
* Chronic or acute pain, except related to other functional syndromes (functional dyspepsia, chronic pelvic pain, fibromyalgia, migrane)
* Bowel resections (except appendectomy)
* Multiple abdominal operations, excluding hysterectomy
* History of brain disease or brain surgery
* Ongoing treatment with any anticoagulants, antidiabetics, antimigraine drugs, antispasmodics, analgesics, psychoactive agents including antidepressants, Zelmac®, TCM or acupuncture for IBS and any drugs affecting nociception as judged by investigator within last 14 days
* Treatment with any investigational drug during the preceding 30 days
* Pregnancy or lactation.
* Claustrophobia
* Metal implants in body (fMRI exclusion criterion)
* No written informed consent obtained from subject
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00693732
Study Brief:
Protocol Section:
NCT00693732