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Rifaximin on Visceral Hypersensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03462966
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : December 29, 2020
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Nipaporn Pichetshote, Cedars-Sinai Medical Center

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 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.

Condition or disease Intervention/treatment Phase
Visceral Hypersensitivity Irritable Bowel Syndrome Drug: Rifaximin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Rifaximin on Visceral Hypersensitivity in Irritable Bowel Syndrome
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Therapeutic
40 subjects with diarrhea-predominant IBS (IBS-D) or mixed IBS (IBS-M) will be enrolled in the study. At the first clinic visit, subjects will undergo rectal sensitivity testing, as well as lactulose breath testing. Subjects will be asked to record their symptoms and bowel habits in a diary over the next 7 days. During the second clinic visit, subjects will receive a 14-day course of rifaximin (550 mg PO TID). During these 14 days, subjects will record their symptoms and bowel habits. Subjects will return to the clinic after completion of the medication and will undergo repeat evaluation via rectal sensitivity testing to assess for change in rectal sensitivity.
Drug: Rifaximin
Rifaximin will be administered to patients diagnosed with IBS-D or IBS-M to evaluate whether the medication is effective in decreasing rectal hypersensitivity. The secondary objective of the study is to assess the role of SIBO in rectal sensitivity.
Other Name: Xifaxan

Primary Outcome Measures :
  1. Mean change in the balloon volume (measured in mL) that leads to first urge to defecate. [ Time Frame: After completing 14-day course of rifaximin. ]
    A 100-mm visual analogue scale with verbal descriptors (0=no sensation, 20=first sensation, 40=first sense of urge, 60=normal urge to defecate, 80=severe urge to defecate, and 100=discomfort/pain) will be used to score evoked sensations.

Secondary Outcome Measures :
  1. Association of urgency symptom and rectal sensitivity testing. [ Time Frame: After completing 14-day course of rifaximin. ]
    Association of urgency symptom and rectal sensitivity will be evaluated by the mean change in the balloon pressure (measured in mmHg) that leads to first sensation, first urge to defecate, and severe urge to defecate as evaluated based on the visual analogue scale defined in the primary outcome measure.

  2. Normalization of lactulose breath test as a potential predictor of improvement of rectal hypersensitivity. [ Time Frame: After completing 14-day course of rifaximin ]
    Normalization of lactulose breath test as a potential predictor of improvement of rectal hypersensitivity will be evaluated by comparing lactulose breath test results pre- and post-treatment.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03462966

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Contact: MAST Program 310.423.0617

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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: MAST Program    310-423-0617   
Sponsors and Collaborators
Cedars-Sinai Medical Center
Bausch Health Americas, Inc.
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Principal Investigator: Nipaporn Pichetshote, MD Cedars-Sinai Medical Center
Mearin F, Lacy BE, Chang L, et al. Bowel Disorders. Gastroenterology 2016;150:1393-1407
Rezaie A, Chua KS, Chang C, et al. Mo2026 Methane on Breath Test Predicts Altered Rectal Sensation During High Resolution Anorectal Manometry. Gastroenterology 2017;146:S-721.

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Responsible Party: Nipaporn Pichetshote, Staff Physician, Cedars-Sinai Medical Center Identifier: NCT03462966    
Other Study ID Numbers: 49509
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Nipaporn Pichetshote, Cedars-Sinai Medical Center:
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Immune System Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents