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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT00583128
Eligibility Criteria:
Inclusion Criteria:
* Body weight ≥ 40 kg;
* Recurrent abdominal pain or discomfort for three or more days per month for the last three months which meets Rome III criteria for non-constipating IBS;
* Patients on a stable diet for at least eight weeks;
* Patients ≥ 50 years of age with a negative screening colonoscopy in the last five years;
* Able and willing to comply with all protocol procedures for the planned duration of the study;
* Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information,
* Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (intrauterine devices, spermicide and barrier) (Hormonal contraceptives are NOT regarded as adequate for the purpose of this trial.) Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.
Exclusion Criteria:
* Constipating IBS;
* History of untreated lactose intolerance;
* History of colonic or major abdominal surgery (colectomy, for example);
* Active (untreated) Thyroid disease;
* Current diagnosis of major depression or psychosis;
* Known positive stool cultures for Clostridium difficile or other pathogens;
* Any condition necessitating the administration of analgesics (except paracetamol), probiotics, neuroleptics, antidepressants for IBS symptoms, daytime tranquilizers, prokinetics or spasmolytic medications;
* Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling;
* Other major physical or major psychiatric illness within the last six months that in the opinion of the investigator would affect the patient's ability to complete the trial;
* Uncontrolled systemic disease such as diabetes;
* Patients undergoing chemotherapy for the treatment of cancer;
* Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used;
* Participation in another study within eight (8) weeks prior to the study;
* Unable to attend all visits required by the protocol;
* Female patients must be excluded if they are pregnant, breast feeding, or planning to become pregnant during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00583128
Study Brief:
Protocol Section:
NCT00583128