Phase
Condition
Hyponatremia
Colic
Stomach Discomfort
Treatment
Placebo
CIN-103
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
- Inclusion Criteria:
Are adult male and female subjects ≥ 18 years of age;
Have a body mass index between 18 and 45 kg/m2, inclusive at Screening;
Meet Rome IV Criteria for IBS-D by subject self-report of recurrent abdominalpain 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) Type 6 or 7 (loose or watery stools) and < 25% of BMs with BSS Type 1 or 2 (lumpy or hardstools) per the Rome IV Criteria for IBS-D;
In the opinion of the Investigator, are on a stable diet for ≥ 4 weeks prior toScreening and are not planning to change lifestyle, exercise, and/or diet thatmay impact symptoms of IBS-D during study participation;
Have a fecal calprotectin ≤ 100 mcg/g at the Screening Visit or Visit 2; Note:A single normal test result is adequate for study eligibility. If subjects arerescreened within 12 months, there is no need for repeat fecal calprotectinsample collection and testing. However, subjects who fail screening due to afecal calprotectin level > 100 mcg/g are not eligible for re-screening. Note:Repeat Fecal calprotectin may be considered with prior Sponsor approval.
Have a serum tTG-IgA (tissue transglutaminase immunoglobulin A) ≤ 4.99 FLU (fluorescent light units) at the Screening Visit;
Have undergone a colonoscopy examination within the designated time intervalprior to randomization, if they meet any of the following criteria. Note: Anegative Cologuard® test result is an acceptable alternative to colonoscopy forsubjects ≥ 45 years and at average risk for colon cancer.
Average risk, based on US Preventive Services Task Force RecommendationStatement for screening of colorectal cancer, with age ≥ 45 years (colonoscopy within 10 years or negative test results on Cologuard within 3 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-degreerelative before age 60 (colonoscopy within 5 years); or
History of colorectal cancer or adenomatous polyps in ≥ 2 first-degreerelatives at any age, or family history of hereditary colorectal cancer orpolyposis (colonoscopy within 5 years).
Exclusion
- Exclusion Criteria:
Have a diagnosis or suspected diagnosis of non-diarrhea predominant IBS (eg,IBS with a subtype of constipation, IBS with mixed or alternating bowel habits,un-subtyped IBS) or functional constipation by the Rome IV Criteria;
Non-infectious chronic lower gastrointestinal conditions including a history ofor current inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis,indeterminate colitis), recurrent diverticulitis, microscopic colitis,lymphocytic colitis, celiac disease, non-celiac gluten sensitivity andnon-compliant on a gluten-free diet, untreated lactose intolerance, carcinoidsyndrome, Lynch syndrome, or familial polyposis, intestinal obstruction,stricture, toxic megacolon, solitary rectal ulcer syndrome, GI perforation,intra-abdominal or pelvic adhesions, ischemic colitis, radiation proctitis,chronic enteritis, non-infectious colitis, or impaired intestinal circulation (eg, aortoiliac disease);Note: Lactose intolerance and non-celiac gluten sensitivity will not exclude asubject from participation if the Investigator documents that the subject iscompliant on a special diet (lactose-free diet or gluten-free diet,respectively) and/or for lactose intolerance is successfully treated withcommercial lactase supplement(s).
Infectious lower gastrointestinal conditions requiring antibiotics ormicrobiome therapy; any microbiologically documented acute lowergastrointestinal colitis or enteritis requiring antibiotic treatment includingsuccessfully treated Clostridioides difficile colitis within 3 months prior toScreening, or a history of recurrent C. difficile colitis at any time in thepast;
Have a known family history of inflammatory bowel disease in at least 1first-degree relative;
Have a known history of a pelvic floor disorder associated with constipation (unless successful treatment has been documented by a normal balloon expulsiontest or anorectal manometry), refractory constipation not responsive tostandard 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 symptomsassociated with abdominal pain or GI discomfort (eg, gastroparesis, functionaldyspepsia, uncontrolled gastroesophageal reflux disease, polycystic kidneydisease, ovarian cysts, urological pain, or endometriosis);
Have a history of or current clinically significant arrhythmias as judged bythe Investigator, including ventricular tachycardia, ventricular fibrillation,and Torsades de pointes. Subjects with any abnormal electrocardiogram (ECG) notconsidered clinically significant by the Investigator are not excluded;
Have current or a history of diverticulitis, heme positive stool, orunexplained GI bleeding within 3 months prior to Screening.Note: Surgically repaired diverticulitis > 3 months prior to Screening ispermitted.
Have a history of surgical resection of the stomach, small, or large intestine;
Have had any major abdominal surgery within the 3 months prior to Screening;Note: Permitted procedures are uncomplicated appendectomy, cholecystectomy, andresection of benign polyps within the 3 months prior to Screening. Subjects whohad an appendectomy that was associated with any related complications orsequelae are eligible if the procedure was performed at least 6 months prior toScreening.
Are currently undergoing or planning to initiate treatment with weight lossmedication during study participation or prior weight loss surgery (eg, gastricbypass surgery, gastric banding);
Have a planned invasive elective surgery during the period of anticipated studyparticipation from the time of informed consent through the last study visit;
Study Design
Connect with a study center
Digestive Health Specialists - Dothan
Dothan, Alabama 36305
United StatesActive - Recruiting
Clinical Research Associates, LLC
Huntsville, Alabama 35801
United StatesActive - Recruiting
Elite Clinical Studies LLC
Phoenix, Arizona 85018
United StatesActive - Recruiting
GI Alliance - Sun City
Sun City, Arizona 85351
United StatesActive - Recruiting
Applied Research Center of Arkansas
Little Rock, Arkansas 72212
United StatesActive - Recruiting
Paragon Rx Clinical, Inc. - Garden Grove
Garden Grove, California 92840
United StatesActive - Recruiting
Gastro Care Institute- lancaster
Lancaster, California 93534
United StatesActive - Recruiting
Medical Associates Research Group
San Diego, California 92123
United StatesActive - Recruiting
American Family Research Group
Cape Coral, Florida 33909
United StatesActive - Recruiting
USA and International Research Inc.
Doral, Florida 33126
United StatesSite Not Available
International Research Associates LLC
Miami, Florida 33183
United StatesActive - Recruiting
Innovation Medical Research Center
Palmetto Bay, Florida 33157
United StatesActive - Recruiting
Velocity Clinical Research,, Savannah
Savannah, Georgia 31406
United StatesActive - Recruiting
Southwest Gastroenterology
Oak Lawn, Illinois 60453
United StatesActive - Recruiting
DelRicht Research
Mandeville, Louisiana 70471
United StatesActive - Recruiting
Tandem Clinical Research GI LLC
Marrero, Louisiana 70072
United StatesActive - Recruiting
Tandem Clinical Research GI LLC
Metairie, Louisiana 70006
United StatesActive - Recruiting
DelRicht Research
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Delta Research Partners, LLC
West Monroe, Louisiana 71291
United StatesActive - Recruiting
DelRicht Research of Bethesda Clinical Trials
Rockville, Maryland 20852
United StatesActive - Recruiting
St. Charles Clinical Research
Weldon Spring, Missouri 63304
United StatesActive - Recruiting
Quality Clinical Research, Inc
Omaha, Nebraska 68114
United StatesActive - Recruiting
Digestive Disease Specialists
Las Vegas, Nevada 89128
United StatesActive - Recruiting
Las Vegas Medical Research
Las Vegas, Nevada 89113
United StatesSite Not Available
Advanced Research Institute - Reno
Reno, Nevada 89511
United StatesActive - Recruiting
Allied Digestive Health Clinical Research Organization
Somers Point, New Jersey 08244
United StatesActive - Recruiting
Allied Digestive Health-Jersey Shore Gastroenterology - Point Commons
Somers Point, New Jersey 08244
United StatesActive - Recruiting
Albuquerque Clinical Trials, Inc
Albuquerque, New Mexico 87102
United StatesActive - Recruiting
Westchester Putnam Gastro
Carmel hamlet, New York 10512
United StatesActive - Recruiting
IMA Clinical Research PC and Affiliates- New York, NY
New York, New York 10128
United StatesActive - Recruiting
NY Scientific
New York, New York 11235
United StatesActive - Recruiting
Atrium Health - Center for Gastroenterology and Hepatology MMP
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Peters Medical Research
High Point, North Carolina 27262
United StatesActive - Recruiting
IMA Clinical Research
Mount Airy, North Carolina 27030
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Remington Davis, Inc.
Columbus, Ohio 43215
United StatesActive - Recruiting
Great Lakes Gastroenterology Research LLC
Mentor, Ohio 44060
United StatesActive - Recruiting
Northshore Gastroenterology Research, LLC
Westlake, Ohio 44145
United StatesActive - Recruiting
Options Health Research LLC
Tulsa, Oklahoma 74104
United StatesActive - Recruiting
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania 17110
United StatesActive - Recruiting
DelRicht Research of Charleston Clinical Trials
Charleston, South Carolina 29407
United StatesActive - Recruiting
Palmetto Clinical Research
Summerville, South Carolina 29485
United StatesActive - Recruiting
Galen Medical Group - Downtown Gastroenterology Location
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
Tri-Cities Gastroenterology
Kingsport, Tennessee 37663
United StatesActive - Recruiting
Advanced Gastroenterology
Union City, Tennessee 38261
United StatesActive - Recruiting
The University of Texas Health Science Center at Houston
Bellaire, Texas 77401
United StatesActive - Recruiting
Care and Cure Clinic
Houston, Texas 77090
United StatesSite Not Available
The Clinical Trials Network LLC
Houston, Texas 77074
United StatesActive - Recruiting
GLRI - McAllen Research
Pharr, Texas 78577
United StatesActive - Recruiting
Gastroenterology Research of San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
Quality Research Inc
San Antonio, Texas 78209
United StatesActive - Recruiting
Advanced Research Institute
Ogden, Utah 84405
United StatesActive - Recruiting
GI Alliance - Washington Gastroenterology
Tacoma, Washington 98405
United StatesActive - Recruiting
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