Overview

Efficacy and Safety of Rifaximin With NAC in IBS-D

Status:
Active, not recruiting

Trial end date:
2022-01-31

Target enrollment:
0

Participant gender:
All

Summary

Randomized, prospective proof of concept, double-blind, single site clinical trial to determine the efficacy of combined rifaximin and N-acetylcysteine (NAC) therapy vs. rifaximin alone in decreasing clinical symptoms in subjects with IBS-D.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Cedars-Sinai Medical Center

Collaborator:

Bausch Health Ireland Limited

Treatments:

Acetylcysteine
N-monoacetylcystine
Rifaximin

Criteria

Inclusion Criteria:

- Male or female subjects aged 18-75 years old inclusive

- Onset of clinical symptoms for IBS-D occurring at least 6 months and, in order to
progress to treatment phase, meet the following:

1. Has abdominal pain, on average, ≥1 day per week in previous 3 months, associated
with ≥2 of the following: (1) Related to defecation, (2) Associated with a change
in stool frequency, or (3) Associated with a change in form (appearance) of
stool.

2. Fits Rome IV criteria for IBS with diarrhea (IBS-D), which is defined by >25% of
abnormal bowel movements with Bristol stool form types 6 or 7 (loose, watery
stool) and <25% of abnormal bowel movements with Bristol stool form types 1 or 2
(hard, lumpy stool).

- Colonoscopy must have been completed within the past 10 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

- All subjects (male and female) shall agree to use an acceptable method of
contraception throughout their participation in the study. Acceptable methods of
contraception include:

1. Double barrier methods (condom with spermicidal jelly or a diaphragm with
spermicide),

2. Hormonal methods (e. g. oral contraceptives, patches or medroxyprogesterone
acetate),

3. An intrauterine device (IUD) with a documented failure rate of less than 1% per
year.

4. Abstinence or partner(s) with a vasectomy may be considered an acceptable method
of contraception at the discretion of the investigator.

5. 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:

- Use of any oral antibiotics 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 inflammatory bowel disease or celiac disease

- History of HIV

- Cirrhosis

- IBS-C/chronic idiopathic constipation

- Poorly controlled diabetes or thyroid disease