CIN-103 for Irritable Bowel Syndrome

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: CinPhloro Pharma, LLC

Must not be taking: Antibiotics

Disqualifiers: Inflammatory bowel disease, Celiac, others

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug CIN-103 for treating Irritable Bowel Syndrome?

Research shows that phloroglucinol, a component of CIN-103, can help reduce abdominal pain and muscle spasms in people with Irritable Bowel Syndrome (IBS), especially those with diarrhea-predominant IBS. Studies indicate it can lessen the increase in gut movement after meals, which may help relieve IBS symptoms.

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Is CIN-103 (Phloroglucinol) safe for humans?

Phloroglucinol, used in treating irritable bowel syndrome, is generally considered safe, but it is important to monitor for any toxic impurities like 3,5-Dichloroaniline that can be present in the formulation.

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How is the drug CIN-103 different from other treatments for irritable bowel syndrome?

CIN-103, which contains phloroglucinol, is unique because it is an antispasmodic drug that specifically targets and relaxes smooth muscles in the gut, helping to relieve abdominal pain and spasms associated with irritable bowel syndrome. This mechanism of action is different from other treatments that may focus on altering gut bacteria or reducing inflammation.

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Eligibility Criteria

Adults over 18 with IBS-D who have a stable diet and aren't planning lifestyle changes that could affect their symptoms. They should have a BMI between 18-40, normal colon cancer screening results based on age, and no significant history of colorectal polyps or other conditions that might interfere with the study.

Inclusion Criteria

In the last 6 months when having a bowel movement, do you have abdominal pain associated with the change in frequency of your stool?

In the last 6 months have you had abdominal pain that's related to a bowel movement?

Have a serum tTG-IgA (tissue transglutaminase immunoglobulin A) ≤ 3 U/mL at the Screening Visit;

Exclusion Criteria

You have been diagnosed with Congestive Heart Failure

You have been diagnosed with Immunocompromised

Do you have any current or a history of diverticulitis, blood in stool, or unexplained GI bleeding in the last 3 months?

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline

Participants complete daily diary and other Patient Reported Outcomes (PROs) to assess eligibility for continued participation

1 visit

1 visit (in-person)

Treatment

Participants receive the study drug CIN-103 or placebo twice daily by mouth for 12 weeks, with daily diaries and other PROs

12 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 visit

1 visit (in-person)

Participant Groups

The trial is testing CIN-103 against a placebo to see if it reduces IBS-D symptoms like abdominal pain and diarrhea. Participants will take the drug or placebo twice daily for 12 weeks and track their symptoms in diaries.

Group I: CIN-103 BID Dose 2 Experimental Treatment 1 Intervention

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

Group II: CIN-103 BID Dose 1 Experimental Treatment 1 Intervention

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

Group III: Placebo for CIN-103 BID Placebo Group 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Allied Digestive Health-Jersey Shore Gastroenterology - Point Commons Somers Point, NJ

Quality Clinical Research, Inc Omaha, NE

Applied Research Center of Arkansas Little Rock, AR

Great Lakes Gastroenterology Research LLC Mentor, OH

More Trial Locations

Who Is Running the Clinical Trial?

CinPhloro Pharma, LLC Lead Sponsor

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Phloroglucinol in irritable bowel syndrome. [2015] To determine the efficacy and tolerability of phloroglucinol, an antispasmodic agent in the treatment of Irritable Bowel Syndrome (IBS).

2. Korea (South) pubmed.ncbi.nlm.nih.gov

The Effect of Phloroglucinol in Patients With Diarrhea-predominant Irritable Bowel Syndrome: A Randomized, Double-blind, Placebo-controlled Trial. [2022] We aim to evaluate the efficacy and safety of phloroglucinol in patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

3. England pubmed.ncbi.nlm.nih.gov

Acute exacerbation of pain in irritable bowel syndrome: efficacy of phloroglucinol/trimethylphloroglucinol. A randomized, double-blind, placebo-controlled study. [2018] Abdominal pain is the predominant symptom in irritable bowel syndrome patients. Phloroglucinol and its methylated derivative are antispasmodic agents acting on smooth muscle.

4. England pubmed.ncbi.nlm.nih.gov

Advanced Spectrophotometric Resolution Techniques for a Spectrally Overlapping Spasmolytic Binary Mixture along with Dichloroaniline as a Toxic Impurity: Application to Content Uniformity Testing. [2022] Irritable bowel syndrome (IBS) is a common disorder leading to undesirable pain. Phloroglucinol (PHG) and trimethylphloroglucinol (TMG) are co-formulated as spasmolytic medication that is considered to be effective in reducing smooth muscle spasm. 3,5-Dichloroaniline (DCL) is a specified PHG pharmacopoeial impurity which needs to be monitored to avoid its toxic effects.

5. France pubmed.ncbi.nlm.nih.gov

[Effect of phloroglucinol on rectosigmoid motility stimulated by a test meal. Study in patients with irritable bowel syndrome]. [2016] Twenty patients (15 women, 5 men, mean age: 46.3 +/- 11.82 years, mean weight: 70.9 +/- 8.83 kg) presenting with a 8.5 +/- 4.7 years' history of irritable bowel syndrome associated predominantly with postprandial abdominal pain were recruited into the study. They underwent, after an enema, a rectosigmoid manometry (4 channels, low compliant infusion pump and catheters) before and after a 1000 kcal standardized meal. At the end of the meal they were administered intravenously phloroglucinol (two 40 mg ampoules) or placebo (two ampoules). Both treatments were strictly similar and the order of administration was randomly assigned Motor activity at the rectum, rectosigmoid, lower sigmoid and sigmoid level was determined using a motor index calculated for each 15 min period. Three preprandial and four postprandial indices were calculated. Both groups were statistically similar for sex ratio, age and history of disease. A slight difference was noted for mean weight: the caloric instake per kg of weight was a little higher in the phloroglucinol group. Mean preprandial indices were comparable in both groups. Variance analysis showed that the increase in postprandial motor indices was statistically less pronounced in the phloroglucinol group than in the placebo group. In the placebo group a clear cut increase in motor activity was assessed, which was not observed in the phloroglucinol group. This variation of motricity, which was observed at every level, was more pronounced for the first two postprandial indices than for the last two ones. These results suggest that phloroglucinol is able to reduce rectosigmoid motor response after a test meal. This could explain its activity in abdominal pain associated with irritable bowel syndrome.

6. England pubmed.ncbi.nlm.nih.gov

Review article: probiotics for the treatment of irritable bowel syndrome--focus on lactic acid bacteria. [2013] Irritable bowel syndrome (IBS) is a poorly understood, yet highly prevalent functional gastrointestinal disorder (FGID). The withdrawal, due to adverse events, of a number of pharmacological agents that were approved for the treatment of IBS has left a therapeutic vacuum for patients suffering from the disorder.

7. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo. [2018] Phloroglucinol is a musculotropic anti-spasmodic drug. It is frequently prescribed in many European countries with a considerable cost for health services. The purpose of this study was to review the existing randomised controlled trials (RCT) comparing the efficacy of phloroglucinol treating abdominal pain versus placebo.