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Rifaximin on Visceral Hypersensitivity

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ClinicalTrials.gov Identifier: NCT03462966
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Nipaporn Pichetshote, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE November 20, 2017
First Posted Date  ICMJE March 13, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
The primary outcome of the study is the 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • Secondary outcome measure will include: [ Time Frame: After completing 14-day course of rifaximin. ]
    Association of urgency symptom and rectal sensitivity testing. This 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.
  • Secondary outcome measure will include: [ Time Frame: After completing 14-day course of rifaximin ]
    Normalization of lactulose breath test as a potential predictor of improvement of rectal hypersensitivity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rifaximin on Visceral Hypersensitivity
Official Title  ICMJE Effects of Rifaximin on Visceral Hypersensitivity in Irritable Bowel Syndrome
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Visceral Hypersensitivity
  • Irritable Bowel Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Rifaximin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MAST Program 310.423.0617 GroupMedicineMASTClinical@cshs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03462966
Other Study ID Numbers  ICMJE 49509
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nipaporn Pichetshote, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Bausch Health Americas, Inc.
Investigators  ICMJE
Principal Investigator: Nipaporn Pichetshote, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP