Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Pharmaceuticals
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant meets the diagnosis of diarrhea-predominant IBS (IBS-D) subtype based on Rome IV diagnostic criteria within 3 months prior to randomization. On days when the participant experiences IBS symptoms
* At least 25% of stools are loose or watery; and
* Fewer than 25% of stools are hard.
Recurrent abdominal pain occurring, on average, at least 1 day per week and associated with 2 or more of the following:
* Related to defecation;
* Associated with a change in frequency of bowel movements;
* Associated with a change in form (appearance) of stool.
Over the week prior to randomization, the participant has
* An average of worst abdominal pain (WAP) scores in the prior 24 hours of 4.0 to 8.0 on a 0 to 10 numerical rating scale;
* An average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 (and at least 5 days with a BSFS score ≥ 5.0;
* An average daily IBS-Global Scale (IBS-GS) score of ≥ 2.0.
Participant must undergo or previously have undergone (a) an appropriate evaluation for their IBS symptoms, including an evaluation for organic/structural etiologies (if in the presence of alarm symptoms); and (b) age-appropriate screening for colorectal cancer, if applicable.
Participant is negative for serum tissue transglutaminase immunoglobulin A antibody (tTG-IgA) plus has evidence of detectable serum IgA within the normal reference range.
You may not be if
At the time of screening, participant has a diagnosis of an IBS subtype other than IBS-D, based on Rome IV criteria.
Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including (but not limited to) inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis, microscopic colitis, and celiac disease).
Participant has had an episode of diverticulitis within 3 months prior to Screening.
Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g., aortoiliac occlusive disease).
Participant has any of the following surgical history:
* Cholecystectomy with any history of post-cholecystectomy biliary tract pain;
* Any abdominal surgery within the 3 months prior to Screening;
* Major gastric, esophageal, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed).
Confirmed alanine aminotransferase (ALT) \> 2 upper limit of normal (ULN)
Confirmed total bilirubin \> ULN, unless the participant has a documented history of Gilbert's syndrome
Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or Human immunodeficiency virus (HIV)-1 or HIV-2 antibody positive
Clareo Health | Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
