Trial Outcomes & Findings for Rifaximin on Visceral Hypersensitivity (NCT NCT03462966)

Last Updated: 2022-09-13

Results Overview

A 100-cubic centimeter 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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

After completing 14-day course of rifaximin.

Results posted on

2022-09-13

Participant Flow

due to recruitment challenges we decided to terminate the clincal trial

Participant milestones

Participant milestones
Measure	Therapeutic 4 subjects with diarrhea-predominant IBS (IBS-D) or mixed IBS (IBS-M) enrolled in the study. At the first clinic visit, subjects did rectal sensitivity testing, as well as lactulose breath testing. Subjects were 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 did repeat evaluation via rectal sensitivity testing to assess for change in rectal sensitivity. 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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rifaximin on Visceral Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapeutic n=4 Participants 4 subjects with diarrhea-predominant IBS (IBS-D) or mixed IBS (IBS-M) enrolled in the study. At the first clinic visit, subjects did rectal sensitivity testing, as well as lactulose breath testing. Subjects were 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 did repeat evaluation via rectal sensitivity testing to assess for change in rectal sensitivity. 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.
Age, Continuous	47.4 years STANDARD_DEVIATION 14.29 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants
the mean change in the balloon volume that lead to the first urge to defecate	28 volume cubic centimeter STANDARD_DEVIATION 17.88 • n=5 Participants

PRIMARY outcome

Timeframe: After completing 14-day course of rifaximin.

Outcome measures

Outcome measures
Measure	Therapeutic n=4 Participants 4 subjects with diarrhea-predominant IBS (IBS-D) or mixed IBS (IBS-M) enrolled in the study. At the first clinic visit, subjects did rectal sensitivity testing, as well as lactulose breath testing. Subjects were 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 did repeat evaluation via rectal sensitivity testing to assess for change in rectal sensitivity. 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.
Mean Change in the Balloon Volume (Measured in Cubic Centimeter) That Leads to First Urge to Defecate.	37.5 volume cubic centimeter Standard Deviation 22.17

SECONDARY outcome

Timeframe: 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 urge sensation to defecate, evaluated based on the visual analogue scale defined in the primary outcome measure.

Outcome measures

Outcome measures
Measure	Therapeutic n=4 Participants 4 subjects with diarrhea-predominant IBS (IBS-D) or mixed IBS (IBS-M) enrolled in the study. At the first clinic visit, subjects did rectal sensitivity testing, as well as lactulose breath testing. Subjects were 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 did repeat evaluation via rectal sensitivity testing to assess for change in rectal sensitivity. 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.
Association of Urgency Symptom and Rectal Sensitivity Testing.	106 Millimetre of mercury Standard Deviation 39.29

SECONDARY outcome

Timeframe: After completing 14-day course of rifaximin

Population: Of the 4 participants, only 2 subjects had a breath test post treatment which is needed for this secondary outcome. Both subjects had a normal breath test after treatment.

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. Normalization of lactulose breath test defined as rise of hydrogen \<20 Parts per million within 90 minutes of lactulose ingestion. patients with positive

Outcome measures

Outcome measures
Measure	Therapeutic n=4 Participants 4 subjects with diarrhea-predominant IBS (IBS-D) or mixed IBS (IBS-M) enrolled in the study. At the first clinic visit, subjects did rectal sensitivity testing, as well as lactulose breath testing. Subjects were 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 did repeat evaluation via rectal sensitivity testing to assess for change in rectal sensitivity. 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.
Number of Participants With a Rise of Hydrogen <20 Parts Per Million Within 90 Minutes of Lactulose Ingestion.(Which is Considered Normal )	2 Participants

Adverse Events

Therapeutic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mohamad Rashid

Cedars-Sinai medical center

Phone: 310-423-0617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place