Phase
Condition
Lactose Intolerance
Fecal Incontinence
Colic
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 4059102, Alabama 4829764 36305
United StatesSite Not Available
Clinical Research Associates, LLC
Huntsville 4068590, Alabama 4829764 35801
United StatesSite Not Available
Elite Clinical Studies LLC
Phoenix 5308655, Arizona 5551752 85018
United StatesSite Not Available
GI Alliance - Sun City
Sun City 5316201, Arizona 5551752 85351
United StatesSite Not Available
Applied Research Center of Arkansas
Little Rock 4119403, Arkansas 4099753 72212
United StatesSite Not Available
Paragon Rx Clinical, Inc. - Garden Grove
Garden Grove 5351515, California 5332921 92840
United StatesSite Not Available
Gastro Care Institute- lancaster
Lancaster 5364940, California 5332921 93534
United StatesSite Not Available
Medical Associates Research Group
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
American Family Research Group
Cape Coral 4149962, Florida 4155751 33909
United StatesSite Not Available
USA and International Research Inc.
Doral 4153471, Florida 4155751 33126
United StatesSite Not Available
International Research Associates LLC
Miami 4164138, Florida 4155751 33183
United StatesSite Not Available
Innovation Medical Research Center
Palmetto Bay 4167634, Florida 4155751 33157
United StatesSite Not Available
Velocity Clinical Research,, Savannah
Savannah 4221552, Georgia 4197000 31406
United StatesSite Not Available
Southwest Gastroenterology
Oak Lawn 4904365, Illinois 4896861 60453
United StatesSite Not Available
DelRicht Research
Mandeville 4332455, Louisiana 4331987 70471
United StatesSite Not Available
Tandem Clinical Research GI LLC
Marrero 4332628, Louisiana 4331987 70072
United StatesSite Not Available
Tandem Clinical Research GI LLC
Metairie 4333177, Louisiana 4331987 70006
United StatesSite Not Available
DelRicht Research
New Orleans 4335045, Louisiana 4331987 70115
United StatesSite Not Available
Delta Research Partners, LLC
West Monroe 4345850, Louisiana 4331987 71291
United StatesSite Not Available
DelRicht Research of Bethesda Clinical Trials
Rockville 4367175, Maryland 4361885 20852
United StatesSite Not Available
St. Charles Clinical Research
Weldon Spring 4413926, Missouri 4398678 63304
United StatesSite Not Available
Quality Clinical Research, Inc
Omaha 5074472, Nebraska 5073708 68114
United StatesSite Not Available
Digestive Disease Specialists
Las Vegas, Nevada 89128
United StatesActive - Recruiting
Digestive Disease Specialists
Las Vegas 5506956, Nevada 5509151 89128
United StatesSite Not Available
Las Vegas Medical Research
Las Vegas 5506956, Nevada 5509151 89113
United StatesSite Not Available
Advanced Research Institute - Reno
Reno 5511077, Nevada 5509151 89511
United StatesSite Not Available
Allied Digestive Health Clinical Research Organization
Somers Point, New Jersey 08244
United StatesActive - Recruiting
Allied Digestive Health Clinical Research Organization
Somers Point 4504186, New Jersey 5101760 08244
United StatesSite Not Available
Allied Digestive Health-Jersey Shore Gastroenterology - Point Commons
Somers Point 4504186, New Jersey 5101760 08244
United StatesSite Not Available
Albuquerque Clinical Trials, Inc
Albuquerque 5454711, New Mexico 5481136 87102
United StatesSite Not Available
IMA Clinical Research PC and Affiliates- New York, NY
New York, New York 10128
United StatesActive - Recruiting
Westchester Putnam Gastro
Carmel Hamlet 7258078, New York 5128638 10512
United StatesSite Not Available
IMA Clinical Research PC and Affiliates- New York, NY
New York 5128581, New York 5128638 10128
United StatesSite Not Available
NY Scientific
New York 5128581, New York 5128638 11235
United StatesSite Not Available
Atrium Health - Center for Gastroenterology and Hepatology MMP
Charlotte 4460243, North Carolina 4482348 28204
United StatesSite Not Available
Peters Medical Research
High Point 4471025, North Carolina 4482348 27262
United StatesSite Not Available
IMA Clinical Research
Mount Airy 4480378, North Carolina 4482348 27030
United StatesSite Not Available
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
Remington Davis, Inc.
Columbus 4509177, Ohio 5165418 43215
United StatesSite Not Available
Great Lakes Gastroenterology Research LLC
Mentor 5162645, Ohio 5165418 44060
United StatesSite Not Available
Northshore Gastroenterology Research, LLC
Westlake 5176517, Ohio 5165418 44145
United StatesSite Not Available
Options Health Research LLC
Tulsa 4553433, Oklahoma 4544379 74104
United StatesSite Not Available
Susquehanna Research Group, LLC
Harrisburg 5192726, Pennsylvania 6254927 17110
United StatesSite Not Available
DelRicht Research of Charleston Clinical Trials
Charleston 4574324, South Carolina 4597040 29407
United StatesSite Not Available
Palmetto Clinical Research
Summerville 4597919, South Carolina 4597040 29485
United StatesSite Not Available
Galen Medical Group - Downtown Gastroenterology Location
Chattanooga 4612862, Tennessee 4662168 37404
United StatesSite Not Available
Tri-Cities Gastroenterology
Kingsport 4634662, Tennessee 4662168 37663
United StatesSite Not Available
Advanced Gastroenterology
Union City 4664170, Tennessee 4662168 38261
United StatesSite Not Available
The Clinical Trials Network LLC
Houston, Texas 77074
United StatesActive - Recruiting
Quality Research Inc
San Antonio, Texas 78209
United StatesActive - Recruiting
The University of Texas Health Science Center at Houston
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
Care and Cure Clinic
Houston 4699066, Texas 4736286 77090
United StatesSite Not Available
The Clinical Trials Network LLC
Houston 4699066, Texas 4736286 77074
United StatesSite Not Available
GLRI - McAllen Research
Pharr 4718721, Texas 4736286 78577
United StatesSite Not Available
Gastroenterology Research of San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Quality Research Inc
San Antonio 4726206, Texas 4736286 78209
United StatesSite Not Available
Advanced Research Institute
Ogden 5779206, Utah 5549030 84405
United StatesSite Not Available
GI Alliance - Washington Gastroenterology
Tacoma 5812944, Washington 5815135 98405
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.