CIN-103 for Irritable Bowel Syndrome

Recruiting at 52 trial locations

Overseen By Lauren Brown

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CinPhloro Pharma, LLC

Must not be taking: Antibiotics

Disqualifiers: Inflammatory bowel disease, Celiac, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CIN-103, a modified formulation of Phloroglucinol, to determine its effectiveness in reducing symptoms of irritable bowel syndrome with diarrhea (IBS-D), such as frequent loose stools and abdominal pain. Researchers aim to assess whether CIN-103 works better than a placebo (a pill with no active medicine) and if it is safe to use. Individuals who frequently experience diarrhea and stomach pain related to IBS-D and have had these symptoms for at least six months might be suitable for this study. Participants will take the study drug twice daily and visit the study site several times over approximately 12 weeks. As a Phase 2 trial, this study measures how well CIN-103 works in an initial, smaller group of people, offering participants a chance to contribute to important research.

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.

Is there any evidence suggesting that CIN-103 is likely to be safe for humans?

Research shows that CIN-103, which contains phloroglucinol, may help relieve symptoms of irritable bowel syndrome (IBS). Phloroglucinol reduces stomach pain and muscle cramps. Previous studies have examined its effects on people with IBS, providing insights into its potential benefits.

This trial is in the early stages of human testing, so researchers are still assessing how well people tolerate the treatment. However, testing on a substantial number of participants aids in understanding its safety.

CIN-103 is designed as a non-opioid treatment, reducing the risk of dependency, a common concern with pain-relief medications. While specific side effects are not detailed, the ongoing study aims to identify and manage any that occur. Those interested in joining this trial should consider this information and consult their healthcare providers to see how it might relate to their health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for irritable bowel syndrome (IBS), which often include dietary changes, fiber supplements, and medications like antispasmodics and laxatives, CIN-103 offers a novel approach. Researchers are excited about CIN-103 because it uses a unique formulation of active ingredients that may target IBS symptoms more directly and effectively. This treatment comes in two dosing options: Dose 1 combines active capsules with placebo, while Dose 2 uses only active capsules, providing flexibility and potentially more tailored relief for patients. By targeting the underlying mechanisms of IBS more precisely, CIN-103 could offer a promising alternative for those not fully satisfied with current options.

What evidence suggests that CIN-103 might be an effective treatment for IBS-D?

Research has shown that CIN-103, which contains phloroglucinol, may help treat symptoms of irritable bowel syndrome with diarrhea (IBS-D). Studies have found that phloroglucinol can significantly reduce stomach pain and improve stool consistency, which are main symptoms of IBS-D. Designed for long-term use, this non-opioid treatment aims to effectively address several IBS symptoms. The current trial will evaluate different dosages of CIN-103 to determine its effectiveness and safety. Current evidence suggests that CIN-103 could be a helpful option for those dealing with IBS-D symptoms. However, more studies are needed to confirm its efficacy and safety. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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?

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• CIN-103

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

CinPhloro Pharma, LLC

Lead Sponsor

Trials

1

Recruited

450+

Published Research Related to This Trial

In a study of 20 patients with irritable bowel syndrome, phloroglucinol significantly reduced the post-meal increase in rectosigmoid motor activity compared to a placebo, suggesting its potential efficacy in managing abdominal pain associated with this condition.

The results indicate that phloroglucinol may help alleviate symptoms by dampening the motor response of the intestines after eating, which could be beneficial for patients experiencing postprandial abdominal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of phloroglucinol on rectosigmoid motility stimulated by a test meal. Study in patients with irritable bowel syndrome]. Cargill, G., Salin, B., Lubin, S., et al.[2016]

A review of 42 trials on lactic acid bacteria (LAB) for treating irritable bowel syndrome (IBS) found that 34 trials reported beneficial effects on symptoms, indicating potential efficacy, but results varied widely in magnitude and outcomes.

Concerns about trial design, including strain selection and dosage, highlight the need for better research methods to ensure safety and long-term tolerability of LAB treatments for IBS, suggesting that future studies should focus on understanding the microbiota's role in health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review article: probiotics for the treatment of irritable bowel syndrome--focus on lactic acid bacteria. Clarke, G., Cryan, JF., Dinan, TG., et al.[2013]

In a study of 100 patients with Irritable Bowel Syndrome (IBS), phloroglucinol was found to significantly improve various symptoms such as abdominal pain, stool frequency, urgency, and bloating over a two-month treatment period.

Phloroglucinol was well tolerated, with a notable improvement in symptoms for females regarding the sense of incomplete defecation, while no significant effect was observed for straining in both genders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phloroglucinol in irritable bowel syndrome. Jafri, W., Yakoob, J., Hussain, S., et al.[2015]

In a study of 72 patients with diarrhea-predominant irritable bowel syndrome (IBS-D), phloroglucinol showed a significant improvement in overall IBS symptoms compared to placebo over a 3-week period, with 61.6% of patients responding positively versus 30.6% in the placebo group.

Phloroglucinol was found to be safe, with no serious adverse events reported, suggesting it could be a beneficial treatment option for managing IBS-D symptoms, although further large-scale studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Phloroglucinol in Patients With Diarrhea-predominant Irritable Bowel Syndrome: A Randomized, Double-blind, Placebo-controlled Trial. Shin, SY., Cha, BK., Kim, WS., et al.[2022]

This study introduces novel spectrophotometric methods to simultaneously measure phloroglucinol (PHG) and trimethylphloroglucinol (TMG) in the presence of the toxic impurity 3,5-dichloroaniline (DCL), ensuring safety in pharmaceutical formulations.

The proposed methods demonstrated comparable accuracy to traditional HPLC techniques for assessing drug content and uniformity in dosage forms, highlighting their reliability and potential for routine quality control.

NCBI (Pubmed)

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. Darweish, E., Marzouk, HM., Fayez, YM., et al.[2022]

In a study involving 307 patients with irritable bowel syndrome, treatment with phloroglucinol/trimethylphloroglucinol for one week resulted in a significant reduction in abdominal pain intensity compared to placebo, with a 57.8% decrease in pain intensity versus 46.3% in the placebo group.

The treatment also led to a higher percentage of patients experiencing at least a 50% reduction in pain (62% in the treatment group vs. 47% in the placebo group), indicating its efficacy as an antispasmodic agent for managing acute pain exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute exacerbation of pain in irritable bowel syndrome: efficacy of phloroglucinol/trimethylphloroglucinol. A randomized, double-blind, placebo-controlled study. Chassany, O., Bonaz, B., Bruley DES Varannes, S., et al.[2018]

A review of three randomized controlled trials (RCTs) found that phloroglucinol, an anti-spasmodic drug, showed no significant superiority over placebo in treating abdominal pain, with a risk ratio of 1.10 and no statistical significance.

Only one of the RCTs indicated a potential benefit of phloroglucinol, but it had a high risk of bias, suggesting that there is insufficient evidence to support its widespread use for abdominal pain relief.

NCBI (Pubmed)

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. Blanchard, C., Pouchain, D., Vanderkam, P., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06153420

NCT06153420 | Study of the Research Medicine CIN-103 ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6955199/

The Effect of Phloroglucinol in Patients With Diarrhea ... Another open-label study reported that phloroglucinol significantly relieved IBS-related symptoms, including abdominal pain, bloating, stool ...

3. businesswire.com businesswire.com/news/home/20240222479569/en/CinPhloro-Pharma-a-CinRx-Portfolio-Company-Dosed-First-Participant-in-Phase-2-enviva-Study-of-CIN-103-for-Irritable-Bowel-Syndrome-with-Predominant-Diarrhea-IBS-D

CinPhloro Pharma, a CinRx Portfolio Company, Dosed ... CIN-103, a novel formulation of phloroglucinol intended for long-term use, is a non-opioid based small molecule designed to address multiple IBS ...

4. ctv.veeva.com ctv.veeva.com/study/study-of-the-research-medicine-cin-103-in-adults-with-irritable-bowel-syndrome-with-predominant-diar

Study of the Research Medicine CIN-103 in Adults with ... 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 ...

5. synapse.patsnap.com synapse.patsnap.com/article/phase-2-enviva-study-initiates-with-first-participant-dosing-for-ibs-d-treatment-cin-103

Phase 2 enviva Study Initiates with First Participant Dosing ... The study will assess the safety, efficacy, and tolerability of CIN-103 in 450 adults suffering from IBS-D. The drug is a non-opioid small ...

6. cinrx.com cinrx.com/cinphloro-pharma-phase-2-enviva-study-cin-103-ibs-d/

CinPhloro Pharma, A CinRx Portfolio Company, Dosed ... CIN-103 is a novel formulation of phloroglucinol designed to sustain exposure, maintain efficacy and reduce dosing frequency.

7. withpower.com withpower.com/trial/phase-2-irritable-bowel-syndrome-11-2023-012d5

CIN-103 for 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).

8. researchgate.net researchgate.net/publication/384004677_Analysis_of_current_data_on_the_safety_and_efficacy_of_the_phloroglucinol_and_simeticone_combination_literature_review

Analysis of current data on the safety and efficacy ... In this report, we examine the clinical safety and efficacy of NG440, a phytochemical-based antiinflammatory formula consisting of a combination ...