TERMINATED

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

Quick Facts

Study Start:2023-12-28

Study Completion:2025-07-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06153420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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). *	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); 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. 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; 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;

Inclusion Criteria

Exclusion 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).
*

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);
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.
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;
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;

Contacts and Locations

Study Locations (Sites)

Digestive Health Specialists - Dothan

Dothan, Alabama, 36305

United States

Clinical Research Associates, LLC

Huntsville, Alabama, 35801

United States

Elite Clinical Studies LLC

Phoenix, Arizona, 85018

United States

GI Alliance - Sun City

Sun City, Arizona, 85351

United States

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212

United States

Paragon Rx Clinical, Inc. - Garden Grove

Garden Grove, California, 92840

United States

Gastro Care Institute- lancaster

Lancaster, California, 93534

United States

Medical Associates Research Group

San Diego, California, 92123

United States

American Family Research Group

Cape Coral, Florida, 33909

United States

USA and International Research Inc.

Doral, Florida, 33126

United States

International Research Associates LLC

Miami, Florida, 33183

United States

Innovation Medical Research Center

Palmetto Bay, Florida, 33157

United States

Velocity Clinical Research,, Savannah

Savannah, Georgia, 31406

United States

Southwest Gastroenterology

Oak Lawn, Illinois, 60453

United States

DelRicht Research

Mandeville, Louisiana, 70471

United States

Tandem Clinical Research GI LLC

Marrero, Louisiana, 70072

United States

Tandem Clinical Research GI LLC

Metairie, Louisiana, 70006

United States

DelRicht Research

New Orleans, Louisiana, 70115

United States

Delta Research Partners, LLC

West Monroe, Louisiana, 71291

United States

DelRicht Research of Bethesda Clinical Trials

Rockville, Maryland, 20852

United States

St. Charles Clinical Research

Weldon Spring, Missouri, 63304

United States

Quality Clinical Research, Inc

Omaha, Nebraska, 68114

United States

Las Vegas Medical Research

Las Vegas, Nevada, 89113

United States

Digestive Disease Specialists

Las Vegas, Nevada, 89128

United States

Advanced Research Institute - Reno

Reno, Nevada, 89511

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

Albuquerque Clinical Trials, Inc

Albuquerque, New Mexico, 87102

United States

Westchester Putnam Gastro

Carmel Hamlet, New York, 10512

United States

IMA Clinical Research PC and Affiliates- New York, NY

New York, New York, 10128

United States

NY Scientific

New York, New York, 11235

United States

Atrium Health - Center for Gastroenterology and Hepatology MMP

Charlotte, North Carolina, 28204

United States

Peters Medical Research

High Point, North Carolina, 27262

United States

IMA Clinical Research

Mount Airy, North Carolina, 27030

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Remington Davis, Inc.

Columbus, Ohio, 43215

United States

Great Lakes Gastroenterology Research LLC

Mentor, Ohio, 44060

United States

Northshore Gastroenterology Research, LLC

Westlake, Ohio, 44145

United States

Options Health Research LLC

Tulsa, Oklahoma, 74104

United States

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110

United States

DelRicht Research of Charleston Clinical Trials

Charleston, South Carolina, 29407

United States

Palmetto Clinical Research

Summerville, South Carolina, 29485

United States

Galen Medical Group - Downtown Gastroenterology Location

Chattanooga, Tennessee, 37404

United States

Tri-Cities Gastroenterology

Kingsport, Tennessee, 37663

United States

Advanced Gastroenterology

Union City, Tennessee, 38261

United States

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401

United States

The Clinical Trials Network LLC

Houston, Texas, 77074

United States

Care and Cure Clinic

Houston, Texas, 77090

United States

GLRI - McAllen Research

Pharr, Texas, 78577

United States

Quality Research Inc

San Antonio, Texas, 78209

United States

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229

United States

Advanced Research Institute

Ogden, Utah, 84405

United States

GI Alliance - Washington Gastroenterology

Tacoma, Washington, 98405

United States

Collaborators and Investigators

Sponsor: CinPhloro Pharma, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-28

Study Completion Date2025-07-28

Study Record Updates

Study Start Date2023-12-28

Study Completion Date2025-07-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Irritable Bowel Syndrome With Diarrhea