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New drug CIN-103 tested for IBS-D, but trial halted early

NCT ID NCT06153420

Symptom relief Sponsor: CinPhloro Pharma, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested whether CIN-103, taken twice daily, could ease symptoms of irritable bowel syndrome with diarrhea (IBS-D) in adults. The study planned to enroll 421 participants and compare two doses of CIN-103 against a placebo over 12 weeks. However, the trial was terminated, so its findings are incomplete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CIN-103
What this could lead to
If it works, this could point toward a new treatment option for people with IBS-D to reduce abdominal pain and improve stool consistency.
What could go wrong
This trial was terminated early, so results are limited. It is still in Phase 2, meaning it is not yet proven safe or effective for widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

421 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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 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: 1. Related to defecation; 2. Associated with a change in frequency of stool; and/or 3. Associated with a change in form (appearance of stool). 4. 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 hard stools) per the Rome IV Criteria for IBS-D; 5. 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; 6. 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 are rescreened within 12 months, there is no need for repeat fecal calprotectin sample collection and testing. However, subjects who fail screening due to a fecal calprotectin level \> 100 mcg/g are not eligible for re-screening. Note: Repeat Fecal calprotectin may be considered with prior Sponsor approval. 7. Have a serum tTG-IgA (tissue transglutaminase immunoglobulin A) ≤ 4.99 FLU (fluorescent light units) at the Screening Visit; 8. Have undergone a colonoscopy examination within the designated time interval prior to randomization, if they meet any of the following criteria. Note: A negative Cologuard® test result is an acceptable alternative to colonoscopy for subjects ≥ 45 years and at average risk for colon cancer. 1. Average risk, based on US Preventive Services Task Force Recommendation Statement for screening of colorectal cancer, with age ≥ 45 years (colonoscopy within 10 years or negative test results on Cologuard within 3 years); 2. Personal history of completely removed adenomatous colorectal polyps (colonoscopy within 5 years for polyps \> 1 cm, within 10 years for polyps \< 1 cm); 3. History of colorectal cancer or adenomatous polyps in a first-degree relative before age 60 (colonoscopy within 5 years); or 4. 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). * 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 of or current inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis, indeterminate colitis), recurrent diverticulitis, 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, 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 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). 3. Infectious lower gastrointestinal conditions requiring antibiotics or microbiome therapy; any microbiologically documented acute lower gastrointestinal colitis or enteritis requiring antibiotic treatment including successfully treated Clostridioides difficile colitis within 3 months prior to Screening, or a history of recurrent C. difficile colitis at any time in the past; 4. Have a known family history of inflammatory bowel disease in at least 1 first-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 expulsion test or anorectal manometry), refractory constipation not responsive to standard 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 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); 7. 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 excluded; 8. 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. 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, and resection of benign polyps within the 3 months prior to Screening. Subjects who had an appendectomy that was associated with any related complications or sequelae are eligible if the procedure was performed at least 6 months prior to Screening. 11. Are currently undergoing or planning to initiate treatment with weight loss medication during study participation or prior weight loss surgery (eg, gastric bypass surgery, gastric banding); 12. Have a planned invasive elective surgery during the period of anticipated study participation from the time of informed consent through the last study visit;

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable bowel syndrome with diarrhea

Contacts and locations

Locations

  • Advanced Gastroenterology

    Union City, Tennessee, 38261, United States

  • Advanced Research Institute

    Ogden, Utah, 84405, United States

  • Advanced Research Institute - Reno

    Reno, Nevada, 89511, United States

  • Albuquerque Clinical Trials, Inc

    Albuquerque, New Mexico, 87102, United States

  • Allied Digestive Health Clinical Research Organization

    Somers Point, New Jersey, 08244, United States

  • Allied Digestive Health-Jersey Shore Gastroenterology - Point Commons

    Somers Point, New Jersey, 08244, United States

  • American Family Research Group

    Cape Coral, Florida, 33909, United States

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212, United States

  • Atrium Health - Center for Gastroenterology and Hepatology MMP

    Charlotte, North Carolina, 28204, United States

  • Care and Cure Clinic

    Houston, Texas, 77090, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinical Research Associates, LLC

    Huntsville, Alabama, 35801, United States

  • DelRicht Research

    Mandeville, Louisiana, 70471, United States

  • DelRicht Research

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research of Bethesda Clinical Trials

    Rockville, Maryland, 20852, United States

  • DelRicht Research of Charleston Clinical Trials

    Charleston, South Carolina, 29407, United States

  • Delta Research Partners, LLC

    West Monroe, Louisiana, 71291, United States

  • Digestive Disease Specialists

    Las Vegas, Nevada, 89128, United States

  • Digestive Health Specialists - Dothan

    Dothan, Alabama, 36305, United States

  • Elite Clinical Studies LLC

    Phoenix, Arizona, 85018, United States

  • GI Alliance - Sun City

    Sun City, Arizona, 85351, United States

  • GI Alliance - Washington Gastroenterology

    Tacoma, Washington, 98405, United States

  • GLRI - McAllen Research

    Pharr, Texas, 78577, United States

  • Galen Medical Group - Downtown Gastroenterology Location

    Chattanooga, Tennessee, 37404, United States

  • Gastro Care Institute- lancaster

    Lancaster, California, 93534, United States

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229, United States

  • Great Lakes Gastroenterology Research LLC

    Mentor, Ohio, 44060, United States

  • IMA Clinical Research

    Mount Airy, North Carolina, 27030, United States

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

    New York, New York, 10128, United States

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157, United States

  • International Research Associates LLC

    Miami, Florida, 33183, United States

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113, United States

  • Medical Associates Research Group

    San Diego, California, 92123, United States

  • NY Scientific

    New York, New York, 11235, United States

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145, United States

  • Options Health Research LLC

    Tulsa, Oklahoma, 74104, United States

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485, United States

  • Paragon Rx Clinical, Inc. - Garden Grove

    Garden Grove, California, 92840, United States

  • Peters Medical Research

    High Point, North Carolina, 27262, United States

  • Quality Clinical Research, Inc

    Omaha, Nebraska, 68114, United States

  • Quality Research Inc

    San Antonio, Texas, 78209, United States

  • Remington Davis, Inc.

    Columbus, Ohio, 43215, United States

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453, United States

  • St. Charles Clinical Research

    Weldon Spring, Missouri, 63304, United States

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110, United States

  • Tandem Clinical Research GI LLC

    Marrero, Louisiana, 70072, United States

  • Tandem Clinical Research GI LLC

    Metairie, Louisiana, 70006, United States

  • The Clinical Trials Network LLC

    Houston, Texas, 77074, United States

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401, United States

  • Tri-Cities Gastroenterology

    Kingsport, Tennessee, 37663, United States

  • USA and International Research Inc.

    Doral, Florida, 33126, United States

  • Velocity Clinical Research,, Savannah

    Savannah, Georgia, 31406, United States

  • Westchester Putnam Gastro

    Carmel Hamlet, New York, 10512, United States

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