Title: Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
Sponsor: CinPhloro
Primary Investigator: Nitin Ahuja, MD
CONTACT: Sophia Caterina (sophia.caterina@pennmedicine.upenn.edu or 215-349-8545)
Inclusion Criteria:
- Are adult male and female subjects ≥ 18 years of age
- Have a body mass index between 18 and 40 kg/m2, inclusive at Screening
- Meet Rome IV Criteria for IBS-D by subject self-report of recurrent abdominal pain that is associated with ≥ 2 of the following over the last ≥ 6 months, with frequency of at least 1 day per week over the last 3 months (on average) before enrollment:
- Related to defecation;
- Associated with a change in frequency of stool; and/or
- Associated with a change in form (appearance of stool)
- Based on Investigator interview of subject's symptoms over the last 3 months, have ≥ 25% of bowel movements (BMs) with Bristol Stool Scale (BSS) types 6 or 7 (loose or watery stools) and < 25% of BMs with BSS Type 1 or 2 (lumpy or hard stools) per the Rome IV Criteria for IBS-D
- In the opinion of the Investigator, are on a stable diet for ≥ 4 weeks prior to Screening and are not planning to change lifestyle, exercise, and/or diet that may impact symptoms of IBS-D during study participation
- Have a fecal calprotectin < 50 mcg/g at the Screening Visit or Visit 2
- Have a serum tTG-IgA (tissue transglutaminase immunoglobulin A) ≤ 3 U/mL at the Screening Visit
- Have undergone a colonoscopy examination within the designated time interval prior to randomization, if they meet any of the following criteria:
- Average risk, based on US Preventive Services Task Force Recommendation Statement for screening of colorectal cancer, with age ≥ 45 years (colonoscopy within 10 years)
- Personal history of completely removed adenomatous colorectal polyps (colonoscopy within 5 years for polyps >1 cm, within 10 years for polyps <1 cm)
- History of colorectal cancer or adenomatous polyps in a first-degree relative before age 60 (colonoscopy within 5 years)History of colorectal cancer or adenomatous polyps in ≥ 2 first-degree relatives at any age, or family history of hereditary colorectal cancer or polyposis (colonoscopy within 5 years); or
- History of or active inflammatory bowel disease in first-degree relative (colonoscopy any time)
Exclusion Criteria:
- Have a diagnosis or suspected diagnosis of IBS with a subtype of constipation, IBS with mixed or alternating bowel habits, un-subtyped IBS, or functional constipation by the Rome IV Criteria
- Have a history of or current inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis, indeterminate colitis), microscopic colitis, lymphocytic colitis, celiac disease, non-celiac gluten sensitivity and non-compliant on a gluten-free diet, untreated lactose intolerance, carcinoid syndrome, Lynch syndrome, or familial polyposis
- Note: Lactose intolerance and non-celiac gluten sensitivity will not exclude a subject from participation if the Investigator documents that the subject is compliant on a special diet (lactose-free diet or gluten-free diet, respectively) and/or for lactose intolerance is successfully treated with commercial lactase supplement(s)
- Have a known history of a pelvic floor disorder (unless successful treatment has been documented by a normal balloon expulsion test), refractory constipation not responsive to standard medical therapy, fecal impaction that required hospitalization, cathartic colon, and/or active proctological condition
- Have a history of or current non-IBS chronic condition(s) with ongoing symptoms associated with abdominal pain or GI discomfort (eg, gastroparesis, functional dyspepsia, uncontrolled gastroesophageal reflux disease, polycystic kidney disease, ovarian cysts, urological pain, or endometriosis)
- Have a history of or current clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, and Torsades de pointes. Subjects with any abnormal electrocardiogram (ECG) not considered clinically significant by the Investigator are not necessarily excluded
- Have current or a history of diverticulitis, heme positive stool, or unexplained GI bleeding within 3 months prior to Screening
- Note: Surgically repaired diverticulitis > 3 months prior to Screening is permitted
- Have a history of surgical resection of the stomach, small, or large intestine