Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D).

Last updated: December 9, 2025
Sponsor: CinPhloro Pharma, LLC
Overall Status: Terminated

Phase

2

Condition

Lactose Intolerance

Fecal Incontinence

Colic

Treatment

Placebo

CIN-103

Clinical Study ID

NCT06153420
CIN-103-121
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea (IBS-D) in adult patients. The main questions it aims to answer are:

  • To evaluate the efficacy of CIN-103 on symptoms of IBS-D when given to patients with IBS-D compared to a placebo.

  • To evaluate the safety and tolerability of CIN-103 when given to patients with IBS-D compared to a placebo

Participants will attend the following visits:

  • Screening Period (1 Visit)

  • Baseline Period (1 Visit)

    • Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued participation.
  • 12-Week Treatment Period (5 Visits)

    • Study drug taken twice daily by mouth.

    • Will complete daily diaries and other PROs as described in the protocol.

  • Follow- Up Period (1 Visit)

Researchers will compare CIN-103 Dose 1, CIN-103 Dose 2, and placebo, to evaluate the clinical response to multiple dose strengths of CIN-103 relative to placebo on abdominal pain and stool consistency along with safety and tolerability.

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  1. Are adult male and female subjects ≥ 18 years of age;

  2. Have a body mass index between 18 and 45 kg/m2, inclusive at Screening;

  3. 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:

  4. Related to defecation;

  5. Associated with a change in frequency of stool; and/or

  6. Associated with a change in form (appearance of stool).

  7. 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;

  8. 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;

  9. 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.

  10. Have a serum tTG-IgA (tissue transglutaminase immunoglobulin A) ≤ 4.99 FLU (fluorescent light units) at the Screening Visit;

  11. 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.

  12. 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);

  13. Personal history of completely removed adenomatous colorectal polyps (colonoscopy within 5 years for polyps > 1 cm, within 10 years for polyps < 1 cm);

  14. History of colorectal cancer or adenomatous polyps in a first-degreerelative before age 60 (colonoscopy within 5 years); or

  15. 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:
  1. 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;

  2. 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).

  3. 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;

  4. Have a known family history of inflammatory bowel disease in at least 1first-degree relative;

  5. 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;

  6. 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);

  7. 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;

  8. 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.

  9. Have a history of surgical resection of the stomach, small, or large intestine;

  10. 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.

  11. Are currently undergoing or planning to initiate treatment with weight lossmedication during study participation or prior weight loss surgery (eg, gastricbypass surgery, gastric banding);

  12. 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

Total Participants: 421
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 28, 2023
Estimated Completion Date:
July 28, 2025

Connect with a study center

  • Digestive Health Specialists - Dothan

    Dothan 4059102, Alabama 4829764 36305
    United States

    Site Not Available

  • Clinical Research Associates, LLC

    Huntsville 4068590, Alabama 4829764 35801
    United States

    Site Not Available

  • Elite Clinical Studies LLC

    Phoenix 5308655, Arizona 5551752 85018
    United States

    Site Not Available

  • GI Alliance - Sun City

    Sun City 5316201, Arizona 5551752 85351
    United States

    Site Not Available

  • Applied Research Center of Arkansas

    Little Rock 4119403, Arkansas 4099753 72212
    United States

    Site Not Available

  • Paragon Rx Clinical, Inc. - Garden Grove

    Garden Grove 5351515, California 5332921 92840
    United States

    Site Not Available

  • Gastro Care Institute- lancaster

    Lancaster 5364940, California 5332921 93534
    United States

    Site Not Available

  • Medical Associates Research Group

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • American Family Research Group

    Cape Coral 4149962, Florida 4155751 33909
    United States

    Site Not Available

  • USA and International Research Inc.

    Doral 4153471, Florida 4155751 33126
    United States

    Site Not Available

  • International Research Associates LLC

    Miami 4164138, Florida 4155751 33183
    United States

    Site Not Available

  • Innovation Medical Research Center

    Palmetto Bay 4167634, Florida 4155751 33157
    United States

    Site Not Available

  • Velocity Clinical Research,, Savannah

    Savannah 4221552, Georgia 4197000 31406
    United States

    Site Not Available

  • Southwest Gastroenterology

    Oak Lawn 4904365, Illinois 4896861 60453
    United States

    Site Not Available

  • DelRicht Research

    Mandeville 4332455, Louisiana 4331987 70471
    United States

    Site Not Available

  • Tandem Clinical Research GI LLC

    Marrero 4332628, Louisiana 4331987 70072
    United States

    Site Not Available

  • Tandem Clinical Research GI LLC

    Metairie 4333177, Louisiana 4331987 70006
    United States

    Site Not Available

  • DelRicht Research

    New Orleans 4335045, Louisiana 4331987 70115
    United States

    Site Not Available

  • Delta Research Partners, LLC

    West Monroe 4345850, Louisiana 4331987 71291
    United States

    Site Not Available

  • DelRicht Research of Bethesda Clinical Trials

    Rockville 4367175, Maryland 4361885 20852
    United States

    Site Not Available

  • St. Charles Clinical Research

    Weldon Spring 4413926, Missouri 4398678 63304
    United States

    Site Not Available

  • Quality Clinical Research, Inc

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Site Not Available

  • Digestive Disease Specialists

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Digestive Disease Specialists

    Las Vegas 5506956, Nevada 5509151 89128
    United States

    Site Not Available

  • Las Vegas Medical Research

    Las Vegas 5506956, Nevada 5509151 89113
    United States

    Site Not Available

  • Advanced Research Institute - Reno

    Reno 5511077, Nevada 5509151 89511
    United States

    Site Not Available

  • Allied Digestive Health Clinical Research Organization

    Somers Point, New Jersey 08244
    United States

    Active - Recruiting

  • Allied Digestive Health Clinical Research Organization

    Somers Point 4504186, New Jersey 5101760 08244
    United States

    Site Not Available

  • Allied Digestive Health-Jersey Shore Gastroenterology - Point Commons

    Somers Point 4504186, New Jersey 5101760 08244
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc

    Albuquerque 5454711, New Mexico 5481136 87102
    United States

    Site Not Available

  • IMA Clinical Research PC and Affiliates- New York, NY

    New York, New York 10128
    United States

    Active - Recruiting

  • Westchester Putnam Gastro

    Carmel Hamlet 7258078, New York 5128638 10512
    United States

    Site Not Available

  • IMA Clinical Research PC and Affiliates- New York, NY

    New York 5128581, New York 5128638 10128
    United States

    Site Not Available

  • NY Scientific

    New York 5128581, New York 5128638 11235
    United States

    Site Not Available

  • Atrium Health - Center for Gastroenterology and Hepatology MMP

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Peters Medical Research

    High Point 4471025, North Carolina 4482348 27262
    United States

    Site Not Available

  • IMA Clinical Research

    Mount Airy 4480378, North Carolina 4482348 27030
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Remington Davis, Inc.

    Columbus 4509177, Ohio 5165418 43215
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research LLC

    Mentor 5162645, Ohio 5165418 44060
    United States

    Site Not Available

  • Northshore Gastroenterology Research, LLC

    Westlake 5176517, Ohio 5165418 44145
    United States

    Site Not Available

  • Options Health Research LLC

    Tulsa 4553433, Oklahoma 4544379 74104
    United States

    Site Not Available

  • Susquehanna Research Group, LLC

    Harrisburg 5192726, Pennsylvania 6254927 17110
    United States

    Site Not Available

  • DelRicht Research of Charleston Clinical Trials

    Charleston 4574324, South Carolina 4597040 29407
    United States

    Site Not Available

  • Palmetto Clinical Research

    Summerville 4597919, South Carolina 4597040 29485
    United States

    Site Not Available

  • Galen Medical Group - Downtown Gastroenterology Location

    Chattanooga 4612862, Tennessee 4662168 37404
    United States

    Site Not Available

  • Tri-Cities Gastroenterology

    Kingsport 4634662, Tennessee 4662168 37663
    United States

    Site Not Available

  • Advanced Gastroenterology

    Union City 4664170, Tennessee 4662168 38261
    United States

    Site Not Available

  • The Clinical Trials Network LLC

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Quality Research Inc

    San Antonio, Texas 78209
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • Care and Cure Clinic

    Houston 4699066, Texas 4736286 77090
    United States

    Site Not Available

  • The Clinical Trials Network LLC

    Houston 4699066, Texas 4736286 77074
    United States

    Site Not Available

  • GLRI - McAllen Research

    Pharr 4718721, Texas 4736286 78577
    United States

    Site Not Available

  • Gastroenterology Research of San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Quality Research Inc

    San Antonio 4726206, Texas 4736286 78209
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden 5779206, Utah 5549030 84405
    United States

    Site Not Available

  • GI Alliance - Washington Gastroenterology

    Tacoma 5812944, Washington 5815135 98405
    United States

    Site Not Available

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