Rifaximin on Visceral Hypersensitivity
| Status: | Recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Neurology |
| Therapuetic Areas: | Gastroenterology, Neurology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/12/2018 |
| Start Date: | July 1, 2018 |
| End Date: | July 2019 |
| Contact: | Tahli Singer-Englar |
| Email: | tahli.singerenglar@cshs.org |
| Phone: | 310.423.3792 |
Effects of Rifaximin on Visceral Hypersensitivity in Irritable Bowel Syndrome
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 States is in excess of $30 billion per year, including indirect costs relating
to loss of productivity of more than $20 billion. Abdominal pain/discomfort (i.e. visceral
hypersensitivity) is present in all patients with IBS and remains the most therapy-resistant
symptom. Apart from abdominal pain, which is measured subjectively using visual scales,
several studies have shown a significant increase in rectal sensitivity, which is measured
objectively using an inflatable balloon. Drugs which are shown to have objective effects on
visceral hypersensitivity are crucial in the management of IBS.
While certain drugs have shown to decrease abdominal pain, there is very little data to
substantiate objective changes in visceral hypersensitivity. Rifaximin is a poorly absorbed
antibiotic and the exact underlying mechanism of action for rifaximin in reducing the pain
component of IBS remains unknown. However, rifaximin has been shown in randomized controlled
trials to decrease abdominal discomfort in all subtypes of IBS.
The investigators hypothesize that rifaximin is effective in decreasing rectal visceral
hypersensitivity in IBS patients. In this study, the investigators propose to test this
hypothesis by measuring visceral hypersensitivity using the graded balloon distention test,
before and after a course of rifaximin. To test whether this effect is accompanied by
treating SIBO, the investigators will also perform lactulose breath tests before and after
rifaximin therapy.
global prevalence of 11% according to a recent meta-analysis. The total cost of managing IBS
in the United States is in excess of $30 billion per year, including indirect costs relating
to loss of productivity of more than $20 billion. Abdominal pain/discomfort (i.e. visceral
hypersensitivity) is present in all patients with IBS and remains the most therapy-resistant
symptom. Apart from abdominal pain, which is measured subjectively using visual scales,
several studies have shown a significant increase in rectal sensitivity, which is measured
objectively using an inflatable balloon. Drugs which are shown to have objective effects on
visceral hypersensitivity are crucial in the management of IBS.
While certain drugs have shown to decrease abdominal pain, there is very little data to
substantiate objective changes in visceral hypersensitivity. Rifaximin is a poorly absorbed
antibiotic and the exact underlying mechanism of action for rifaximin in reducing the pain
component of IBS remains unknown. However, rifaximin has been shown in randomized controlled
trials to decrease abdominal discomfort in all subtypes of IBS.
The investigators hypothesize that rifaximin is effective in decreasing rectal visceral
hypersensitivity in IBS patients. In this study, the investigators propose to test this
hypothesis by measuring visceral hypersensitivity using the graded balloon distention test,
before and after a course of rifaximin. To test whether this effect is accompanied by
treating SIBO, the investigators will also perform lactulose breath tests before and after
rifaximin therapy.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-3792
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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