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Irritable Bowel Syndrome With DiarrheaPhase 2NCT06153420

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

A Phase 2 study testing CIN-103 in people with Irritable Bowel Syndrome With Diarrhea, run by CinPhloro Pharma, LLC at 53 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irritable Bowel Syndrome With Diarrhea
What is being tested?
CIN-103
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
421 participants
Where
53 sitesUnited States
Study dates
28 Dec 2023to 28 Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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).

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • Albuquerque Clinical Trials, Inc

    Albuquerque, New Mexico, 87102

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401

  • American Family Research Group

    Cape Coral, Florida, 33909

  • Westchester Putnam Gastro

    Carmel Hamlet, New York, 10512

  • DelRicht Research of Charleston Clinical Trials

    Charleston, South Carolina, 29407

  • Atrium Health - Center for Gastroenterology and Hepatology MMP

    Charlotte, North Carolina, 28204

  • Galen Medical Group - Downtown Gastroenterology Location

    Chattanooga, Tennessee, 37404

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Remington Davis, Inc.

    Columbus, Ohio, 43215

  • USA and International Research Inc.

    Doral, Florida, 33126

  • Digestive Health Specialists - Dothan

    Dothan, Alabama, 36305

  • Paragon Rx Clinical, Inc. - Garden Grove

    Garden Grove, California, 92840

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110

  • Peters Medical Research

    High Point, North Carolina, 27262

  • The Clinical Trials Network LLC

    Houston, Texas, 77074

  • Care and Cure Clinic

    Houston, Texas, 77090

  • Clinical Research Associates, LLC

    Huntsville, Alabama, 35801

  • Tri-Cities Gastroenterology

    Kingsport, Tennessee, 37663

  • Gastro Care Institute- lancaster

    Lancaster, California, 93534

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Digestive Disease Specialists

    Las Vegas, Nevada, 89128

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

  • DelRicht Research

    Mandeville, Louisiana, 70471

  • Tandem Clinical Research GI LLC

    Marrero, Louisiana, 70072

  • Great Lakes Gastroenterology Research LLC

    Mentor, Ohio, 44060

  • Tandem Clinical Research GI LLC

    Metairie, Louisiana, 70006

  • International Research Associates LLC

    Miami, Florida, 33183

  • IMA Clinical Research

    Mount Airy, North Carolina, 27030

  • DelRicht Research

    New Orleans, Louisiana, 70115

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

    New York, New York, 10128

  • NY Scientific

    New York, New York, 11235

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Quality Clinical Research, Inc

    Omaha, Nebraska, 68114

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • GLRI - McAllen Research

    Pharr, Texas, 78577

  • Elite Clinical Studies LLC

    Phoenix, Arizona, 85018

  • Advanced Research Institute - Reno

    Reno, Nevada, 89511

  • DelRicht Research of Bethesda Clinical Trials

    Rockville, Maryland, 20852

  • Quality Research Inc

    San Antonio, Texas, 78209

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • Medical Associates Research Group

    San Diego, California, 92123

  • Velocity Clinical Research,, Savannah

    Savannah, Georgia, 31406

  • Allied Digestive Health Clinical Research Organization

    Somers Point, New Jersey, 08244

  • Allied Digestive Health-Jersey Shore Gastroenterology - Point Commons

    Somers Point, New Jersey, 08244

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • GI Alliance - Sun City

    Sun City, Arizona, 85351

  • GI Alliance - Washington Gastroenterology

    Tacoma, Washington, 98405

  • Options Health Research LLC

    Tulsa, Oklahoma, 74104

  • Advanced Gastroenterology

    Union City, Tennessee, 38261

  • St. Charles Clinical Research

    Weldon Spring, Missouri, 63304

  • Delta Research Partners, LLC

    West Monroe, Louisiana, 71291

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145

Other trials in United States

About this study

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)

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
Read more

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.

Being tested
CIN-103, Placebo
Keywords
Irritable Bowel Syndrome, IBS-D, IBS, IBS with diarrhea, Abdominal pain with diarrhea, IBS with loose stool
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIN-103Drug

    CIN-103 BID

  • PlaceboDrug

    Placebo for CIN-103 BID

Study groups in NCT06153420
Study groupRoleWhat they receive
CIN-103 BID Dose 1ExperimentalCIN-103 Dose 1, administered as 2 x CIN-103 capsules and 2 x matching placebo per dose. Two doses per day.
Receives: Drug: CIN-103
CIN-103 BID Dose 2ExperimentalCIN-103 Dose 2, administered as 4 x CIN-103 capsules per dose. Two doses per day.
Receives: Drug: CIN-103
Placebo for CIN-103 BIDPlacebo comparatorPlacebo for CIN-103, administered as 4 x matching placebo capsules per dose. Two doses per day.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks of Double Blind Treatment Period

Secondary outcomes (17)

  1. The occurrence of meeting Weekly Composite Responder status

    Measured: 12-week of Double-Blind Treatment Period

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

    A subject is defined as a Weekly Composite Responder if he or she meets both abdominal pain and stool consistency criteria as follows: An Abdominal Pain Intensity Weekly Responder is defined as a subject who experiences a decrease in the weekly average of WAP in the past 24 hours score of at least 30% compared with Baseline; AND A Stool Consistency Weekly Responder is defined as a subject who experiences a 50% or greater reduction in the number of days per week with at least 1 stool that has a consistency of Type 6 or 7 compared with Baseline.

    Measured: 12 weeks of Double Blind Treatment Period

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

    The subject-reported WAP in the past 24 hours will be recorded on an 11-point (ie, 0 to 10) numeric rating scale, where 0 corresponds to no pain and 10 corresponds to worst imaginable pain. The stool consistency will be measured using the Bristol Stool Score, based on a 1 to 7 scale where 1 corresponds to a hard stool and 7 corresponds to watery diarrhea.

    Measured: 12-week of Double-Blind Treatment Period

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

    Measured: 12-week of Double-Blind Treatment Period

  5. The occurrence of meeting Stool Consistency Responder status

    A participant is considered a Stool Consistency Responder if there is an improvement in stool consistency based on the BSS score < 5 or the absence of a bowel movement over the past 24 hours.

    Measured: 12-week of Double-Blind Treatment Period

  6. The change in the daily mean and weekly mean of stool consistency measured with the Bristol Stool Scale (BSS) as compared to Baseline

    The subject-reported BSS consistency score is based on a 1 to 7 scale where 1 corresponds to a hard stool and 7 corresponds to watery diarrhea.

    Measured: 12-week of Double-Blind Treatment Period

  7. The occurrence of meeting Pain Responder status

    A participant is considered a Pain Responder if there is an improvement in the mean daily 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).

    Measured: 12-week of Double-Blind Treatment Period

  8. The change in the daily mean and weekly mean of daily WAP as compared to Baseline

    Measured: 12-week of Double-Blind Treatment Period

  9. The change in the daily mean and weekly mean of daily abdominal bloating score as compared to Baseline.

    The subject-reported abdominal bloating in the past 24 hours will be recorded on an 11-point (ie, 0 to 10) numeric rating scale, where 0 corresponds to no bloating and 10 corresponds to worst imaginable bloating.

    Measured: 12-week of Double-Blind Treatment Period

  10. The change in the daily mean and weekly mean of daily urgency score compared to Baseline.

    Daily urgency score is measured on a numeric rating scale from 0 (no urgency) to 10 (worst possible urgency).

    Measured: 12-week of Double-Blind Treatment Period

  11. The change in daily mean and weekly mean number of fecal incontinence episodes compared to Baseline

    Subjects will receive daily automatic reminders on eDiary to record the number of fecal incontinence episodes over the past 24 hours.

    Measured: 12-week of Double-Blind Treatment Period

  12. Incidence of clinically significant changes, in the Investigator's opinion, in vital signs, physical examinations, ECGs, and clinical laboratory evaluations.

    Including standard safety chemistry panel, hematology, coagulation, lipids, and urinalysis.

    Measured: Through study completion, up to 19 weeks.

  13. Occurrence of Treatment-Emergent Adverse Events (TEAEs).

    Measured: Through study completion, up to 19 weeks.

  14. Occurrence of treatment-emergent serious adverse events.

    Measured: Through study completion, up to 19 weeks.

  15. Occurrence of TEAEs leading to premature discontinuation of the study drug.

    Measured: Through study completion, up to 19 weeks.

  16. Occurrence of treatment-emergent clinically significant laboratory abnormalities.

    Measured: Through study completion, up to 19 weeks.

  17. Percentage of post-randomization days with symptom of urgency present ("Yes")

    The severity of bowel urgency will be captured on a numeric rating scale from 0 (no urgency) to 10 (worst possible urgency). Using this scale, bowel urgency will also be captured as not present "No" (score 0) or present "Yes" (score 1 to 10).

    Measured: 12-week of Double-Blind Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2023
  2. Study start28 Dec 2023
  3. Primary completion28 Jul 2025
  4. Study completion28 Jul 2025

Why it stopped: The study was terminated due to lack of efficacy compared to placebo.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06153420
Sponsor's protocol ID
CIN-103-121
Status last verified
Oct 2025
First submitted
9 Nov 2023
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CIN-103 in people with Irritable Bowel Syndrome With Diarrhea, run by CinPhloro Pharma, LLC at 53 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to lack of efficacy compared to placebo.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of meeting Study Composite Responder status for an adult subject with IBS-D. (time frame: 12 weeks of Double Blind Treatment Period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06153420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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