Sex Differences in Effectiveness of CBT on IBS Project 3

Exclusion criteria

• . Evidence of structural abnormality of the gastrointestinal tract. Exclusionary GI conditions include but are not limited to gastrointestinal surgery (exceptions: appendectomy, benign polypectomy, cholecystectomy).
• . Presence of a significant and ongoing medical problem that would interfere with participation in the study or testing the study hypotheses (e.g., major heart disease, neurological disorders, inflammatory diseases such as IBD; esophagitis, celiac disease, gastrointestinal malignancy or obstruction, peptic, duodenal or gastric ulcer disease, etc.). Malignancy (other than localized skin cancer that has been resected) within the previous 5 years.
• . Presence of a major psychiatric diagnosis such as schizophrenia, Bipolar disorder, current ADD diagnosis, Post-traumatic Stress Disorder, Obsessive Compulsive disorder or current history of tobacco or alcohol abuse. Subjects with a history of DSMIV diagnosis of Anxiety or Depression in whom symptoms are not active, will be allowed but noted for post-hoc analysis.
• . Use of investigational drugs, products or devices within 28 days prior to screen and through study participation.
• . Subjects with current regular use of narcotics and or opioids. Use of centrally acting medications that will interfere with the neuroimaging testing (such as systemic steroids, opiate analgesics). Medications which alter GI motility and gastric pH will need to be stopped at least 72 hours prior to any physiologic test visit and during the baseline and treatment intervention. For this we will ask the subject to get approval from their own PCP to stop prior to any intervention. However, rescue medication of bisacodyl and loperamide will be allowed for prolonged constipation and diarrhea, respectively, during intervention periods but not during baseline or within 3 days of follow up MRI. For rescue medication, such as laxatives or antidiarrheal, we will ask to hold off use up to 3 days prior to collecting stool sample.
• . Obesity (BMI \>35)
• . Subjects with claustrophobia, metal implants, dental braces, large tattoos (e.g. full arm or back); making MRI safety not possible.
• . History of heavy use of tobacco products or current use of more than 1/3 ppd.