CompletedPhase 1/2

Efficacy and Safety of Rifaximin With NAC in IBS-D

United States45 participantsStarted 2020-11-13

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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).
. Double barrier methods (condom with spermicidal jelly or a diaphragm with spermicide),
. Hormonal methods (e. g. oral contraceptives, patches or medroxyprogesterone acetate),
. 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.
. 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".

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Stool Form

Timeframe: value at 6 weeks minus value at baseline

Change in Abdominal Pain

Timeframe: value at 6 weeks minus value at baseline

Change in Stool Frequency

Timeframe: value at 6 weeks minus value at baseline

Trial details

NCT IDNCT04557215

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-31

Results submitted2022-12-20

View on ClinicalTrials.gov More Irritable Bowel Syndrome With Diarrhea trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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).
. Double barrier methods (condom with spermicidal jelly or a diaphragm with spermicide),
. Hormonal methods (e. g. oral contraceptives, patches or medroxyprogesterone acetate),
. 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.
. 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".