Table 1.
Inclusion and exclusion criteria
| Inclusion criteria |
| The patient is 18 years of age or older |
| The patient is fluent in US English and capable of comprehending and signing an informed consent form for participation |
| The patient has a clinician-confirmed diagnosis of IBS-D |
| If yes, please rate the severity of the patient’s IBS-D: |
| □1 Very mild |
| □2 Mild |
| □3 Moderate |
| □4 Severe |
| □5 Very severe |
| The patient has experienced IBS-D symptoms for at least 6 months prior to diagnosis |
| The patient has experienced recurrent abdominal pain or discomfort associated with two of the three following features, at least 3 days a month, for the last 3 months |
| • Improvement with defecation |
| • Onset associated with a change in frequency of stool |
| • Onset associated with a change in form (appearance) of stool |
| The patient has experienced loose (mushy) or watery stools (type 6 or 7 on the Bristol Stool Form Scale) in at least 25 % of bowel movements and hard or lumpy stool in fewer than 25 % of bowel movements in the absence of use of anti-diarrheals or laxatives in the last 3 months |
| Exclusion criteria |
| The patient has an organic disease or functional gastrointestinal syndrome, other than IBS, potentially affecting the digestive tract passage or colonic function, including structure, obstruction, or ileus |
| The patient has a bowel movement characterized as a Bristol Stool Form Scale of 3 or less in the last 7 days prior to enrollment |
| The patient has benign polyps or colonic diverticulosis judged to have an influence on the digestive tract passage or colonic function |
| Does the patient have a history of surgical resection of stomach, small intestine, or large intestine (excluding resection of appendix or benign polyps)? |
| The patient has a history of ischemic colitis, history of unexplained blood passage per rectum |
| The patient has uncontrolled lactose intolerance, or is the patient receiving radiotherapy for abdominal disease? |
| The patient has a history of drug or alcohol abuse within past year or history of major psychiatric disorders or current significant depression or anxiety |
| The patient has cardiovascular, pulmonary, endocrine, metabolic, hematologic, neurologic, or gastrointestinal (excluding IBS) disease |
| The patient has a history of thyroid dysfunction |