Effects of Phloroglucinol vs. Placebo on IBS-D (Irritable

Recruiting

18-99 years

All

Phase 2

1 Location

Brief description of study

To evaluate the clinical response of multiple dose strengths of CIN-103 relative to placebo on abdominal pain and stool consistency (as a composite responder) in subjects with IBS-D (Irritable Bowel Syndrome Prominently Diarrhea) over 12 weeks of treatment and the safety and tolerability of multiple dose strengths of CIN-103 relative to placebo in subjects with IBS-D over 12 weeks of treatment. The population is adult subjects 18 years and older who meet Rome IV Criteria for IBS-D and do not have evidence of other gastrointestinal diseases.

Detailed description of study

There will be a total of 8 visits to the site and 1 phone call. Upon completion of each visit, the participant will be compensated up to $125 per visit. Participants must be willing to sit in the facility between 1-3 hours, have blood draws, and complete a daily e-Diary of symptoms. Participants who complete the e-Diary will be eligible for additional compensation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: IBS-D
Age: Between 18 Years - 99 Years
Gender: All

Inclusion Criteria:

Diagnosed by a healthcare professional with IBS-D (Irritable Bowel Syndrome Predominantly Diarrhea)
Restrict certain IBS medications prior and during of the study

Exclusion Criteria:

Pregnant, planning pregnancy, or lactating during the study
Currently or planning to use weight loss medication/GLP-1 agonist (ex. Ozempic, Trulicity, Mounjaro, ect.)
The use of rifaximin 90 days prior or planning to use during the duration of the study
Probiotics, supplements, and nutraceuticals for the use of IBS-D treatment (ex. Align, Viberzi, Truberzi, Lotronex, etc.)
The use of dicyclomine (brand name Bentyl, ect.), hyoscyamine (brand names ED-Spaz, Hyosyne, ect.) hyoscine (brand name Buscopan, ect.), and peppermint oil
THC/Marijana use without a medical card or documentation from a physician for medical use
History of any cancer (with the exception of basal or squamous cell carcinoma of the skin) that has not been resolved or been in remission for ≥5 years

Updated on 01 Aug 2024. Study ID: 854995

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