Proposal Evaluating Time-specific Relationships Between Variables of Pain, Stress, and Bloating in IBS Diarrhea and Constipation Symptoms Using a Palm Pilot

Inclusion criteria

• The subject signs and dates a written informed consent form (ICF) prior to any study-related activities, including discontinuation of any prohibited medications.
• The subject has been diagnosed with either IBS-C, IBS-D, IBS-M, or has no history of gastrointestinal symptoms (control group).
• The subject has at least 3 pain episodes a week and does not have constant, unremitting abdominal pain.
• The subject is at least 18 years of age and less than 75 years of age at the time of the screening visit.
• The subject is fluent in English.
• The subject is an ambulatory outpatient. Ambulatory is defined as not depending exclusively on a wheelchair for mobility. Nursing home subjects may be enrolled provided they are ambulatory. Subjects with spinal cord injuries resulting in paraplegia may not be enrolled.

Exclusion criteria

• The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but are not limited to) the following:

• Inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• GI surgery (with the exceptions of appendectomy; cholecystectomy; benign polypectomy; fundoplication without gas bloat syndrome, 6 months post-surgery; herniorrhaphy without bowel resection, 1 month post-surgery; hemorrhoidectomy, at least 2 months post-surgery; and hiatal hernia repair),
• GI malignancy, GI obstruction
• In the opinion of the investigator the subject has a concurrent illness or disability (excluding IBS) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurological condition).
• The subject has been diagnosed with a major psychiatric disorder within the past 2 years that required hospitalization and/or involved an attempted suicide (e.g., major depression or psychoses). Subjects diagnosed with a major psychiatric disorder that did not require hospitalization or involve an attempted suicide must have remained on a stable dose of medication for at least 6 months prior to the screening visit.
• The subject has a history of alcohol or substance abuse within the past 2 years.
• The subject has any evidence or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous 5 years.