Status:
TERMINATED
Rifaximin on Visceral Hypersensitivity
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Visceral Hypersensitivity
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders, with a global prevalence of 11% according to a recent meta-analysis. The total cost of managing IBS in the United S...
Eligibility Criteria
Inclusion
- Male or female subjects aged 18-75 years old inclusive
- Meet Rome IV criteria for IBS-D or IBS-M
- Subjects should report urgency with bowel movement at least once a week
- If subjects are ≥50 years old, a colonoscopy must have been completed within the past 5 years
- Subjects are capable of understanding the requirements of the study, are willing to comply with all the study procedures, and are willing to attend all study visits.
- Agree to use an acceptable method of contraception throughout their participation in the study. Acceptable methods of contraception include: double barrier methods (condom with spermicidal jelly or a diaphragm with spermicide); hormonal methods (e. g. oral contraceptives, patches or medroxyprogesterone acetate); or an intrauterine device (IUD) with a documented failure rate of less than 1% per year. Abstinence or partner(s) with a vasectomy may be considered an acceptable method of contraception at the discretion of the investigator.
- All subjects will provide Institutional Review Board (IRB)-approved informed written consent prior to beginning any study-related activities
- NOTE: Female subjects who have been surgically sterilized (e.g. hysterectomy or bilateral tubal ligation) or who are postmenopausal (total cessation of menses for \>1 year) will not be considered "females of childbearing potential".
Exclusion
- Treatment with antibiotics or Xifaxan in the last two months
- Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)
- Subjects with known pelvic floor dysfunction
- Pregnancy
- Nursing mothers
- Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures
- History of bowel obstruction
- History of celiac disease
- History of inflammatory bowel disease
- Cirrhosis
- IBS-C/chronic idiopathic constipation
- Diabetes
- History of anorectal radiation/surgery
- History of prostatitis
- Known allergy or hypersensitivity to rifaximin or rifamycin
- Current treatment with eluxadoline or opiates
- NOTE: Development of any of the exclusion criteria during the study will be considered a basis for subject discontinuation.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03462966
Start Date
July 1 2018
End Date
November 19 2021
Last Update
September 13 2022
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048