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

NCT06153420 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: CIN-103-121
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 53

Brief 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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

Irritable Bowel Syndrome; IBS-D; IBS; IBS with diarrhea; Abdominal pain with diarrhea; IBS with loose stool

Outcome Measures

Primary Outcomes (1)

• Occurrence of meeting Study Composite Responder status for an adult subject with IBS-D.

  A subject is defined as a Study Composite Responder if he or she meets the Daily Composite Responder criteria for at least 50% of days with diary entry during the 12-week Double-Blind Treatment Period. A subject is defined as a Daily Composite Responder if he or she meets both the pain intensity and stool consistency criteria as follows: * Improvement in the mean daily worst abdominal pain (WAP) score by ≥ 30% compared to the mean daily WAP score from the Baseline Period (the average of the daily measurements over the 14 days prior to randomization); AND * Improvement in stool consistency based on the Bristol Stool Scale (BSS) score \< 5 or the absence of a bowel movement (BM) over the past 24 hours. Note: If a subject did not have a BM, an improvement of at least 30% in the WAP score is sufficient for a response on that day. The proportion of subjects with a primary outcome within each dose of CIN-103 will be compared to the proportion of subjects in the placebo arm.

  12 weeks of Double Blind Treatment Period

Secondary Outcomes (17)

• The occurrence of meeting Weekly Composite Responder status

  12-week of Double-Blind Treatment Period

• The occurrence of meeting Weekly Composite Responder status over 4-weekly intervals (1 to 4, 5 to 8, and 9 to 12 weeks).

  12 weeks of Double Blind Treatment Period

• The change in a composite of the daily mean and weekly mean of daily WAP score and stool consistency score as compared to Baseline

  12-week of Double-Blind Treatment Period

• The change in daily mean and weekly mean number of BMs per day compared to Baseline

  12-week of Double-Blind Treatment Period

• The occurrence of meeting Stool Consistency Responder status

  12-week of Double-Blind Treatment Period

Study Arms (3)

CIN-103 BID Dose 1

EXPERIMENTAL

CIN-103 Dose 1, administered as 2 x CIN-103 capsules and 2 x matching placebo per dose. Two doses per day.

Drug: CIN-103

CIN-103 BID Dose 2

EXPERIMENTAL

CIN-103 Dose 2, administered as 4 x CIN-103 capsules per dose. Two doses per day.

Drug: CIN-103

Placebo for CIN-103 BID

PLACEBO COMPARATOR

Placebo for CIN-103, administered as 4 x matching placebo capsules per dose. Two doses per day.

Drug: Placebo

Interventions

CIN-103 DRUG

CIN-103 BID

CIN-103 BID Dose 1; CIN-103 BID Dose 2

Placebo DRUG

Placebo for CIN-103 BID

Placebo for CIN-103 BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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) 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;
• 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 ≤ 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.
• 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 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.
• 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);
• 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); or
• 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).

You may not qualify if:

• 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 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).
• 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;
• Have a known family history of inflammatory bowel disease in at least 1 first-degree relative;
• 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;
• 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 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;
• 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.
• 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);
• Have a planned invasive elective surgery during the period of anticipated study participation from the time of informed consent through the last study visit;

Sponsors & Collaborators

• CinPhloro Pharma, LLC: lead

Study Sites (53)

Digestive Health Specialists - Dothan

Dothan, Alabama, 36305, United States

Location

Clinical Research Associates, LLC

Huntsville, Alabama, 35801, United States

Location

Elite Clinical Studies LLC

Phoenix, Arizona, 85018, United States

Location

GI Alliance - Sun City

Sun City, Arizona, 85351, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Paragon Rx Clinical, Inc. - Garden Grove

Garden Grove, California, 92840, United States

Location

Gastro Care Institute- lancaster

Lancaster, California, 93534, United States

Location

Medical Associates Research Group

San Diego, California, 92123, United States

Location

American Family Research Group

Cape Coral, Florida, 33909, United States

Location

USA and International Research Inc.

Doral, Florida, 33126, United States

Location

International Research Associates LLC

Miami, Florida, 33183, United States

Location

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

Location

Velocity Clinical Research,, Savannah

Savannah, Georgia, 31406, United States

Location

Southwest Gastroenterology

Oak Lawn, Illinois, 60453, United States

Location

DelRicht Research

Mandeville, Louisiana, 70471, United States

Location

Tandem Clinical Research GI LLC

Marrero, Louisiana, 70072, United States

Location

Tandem Clinical Research GI LLC

Metairie, Louisiana, 70006, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

Delta Research Partners, LLC

West Monroe, Louisiana, 71291, United States

Location

DelRicht Research of Bethesda Clinical Trials

Rockville, Maryland, 20852, United States

Location

St. Charles Clinical Research

Weldon Spring, Missouri, 63304, United States

Location

Quality Clinical Research, Inc

Omaha, Nebraska, 68114, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89113, United States

Location

Digestive Disease Specialists

Las Vegas, Nevada, 89128, United States

Location

Advanced Research Institute - Reno

Reno, Nevada, 89511, United States

Location

Allied Digestive Health Clinical Research Organization

Somers Point, New Jersey, 08244, United States

Location

Allied Digestive Health-Jersey Shore Gastroenterology - Point Commons

Somers Point, New Jersey, 08244, United States

Location

Albuquerque Clinical Trials, Inc

Albuquerque, New Mexico, 87102, United States

Location

Westchester Putnam Gastro

Carmel Hamlet, New York, 10512, United States

Location

IMA Clinical Research PC and Affiliates- New York, NY

New York, New York, 10128, United States

Location

NY Scientific

New York, New York, 11235, United States

Location

Atrium Health - Center for Gastroenterology and Hepatology MMP

Charlotte, North Carolina, 28204, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

IMA Clinical Research

Mount Airy, North Carolina, 27030, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Remington Davis, Inc.

Columbus, Ohio, 43215, United States

Location

Great Lakes Gastroenterology Research LLC

Mentor, Ohio, 44060, United States

Location

Northshore Gastroenterology Research, LLC

Westlake, Ohio, 44145, United States

Location

Options Health Research LLC

Tulsa, Oklahoma, 74104, United States

Location

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110, United States

Location

DelRicht Research of Charleston Clinical Trials

Charleston, South Carolina, 29407, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Galen Medical Group - Downtown Gastroenterology Location

Chattanooga, Tennessee, 37404, United States

Location

Tri-Cities Gastroenterology

Kingsport, Tennessee, 37663, United States

Location

Advanced Gastroenterology

Union City, Tennessee, 38261, United States

Location

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

Location

The Clinical Trials Network LLC

Houston, Texas, 77074, United States

Location

Care and Cure Clinic

Houston, Texas, 77090, United States

Location

GLRI - McAllen Research

Pharr, Texas, 78577, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

GI Alliance - Washington Gastroenterology

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 1, 2023
• Study Start: December 28, 2023
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (53)