Efficacy and Safety of Rifaximin With NAC in IBS-D

NCT04557215 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 550
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

Irritable Bowel Syndrome with Diarrhea; IBS-D; Rifaximin; N-acetylcysteine; NAC

Outcome Measures

Primary Outcomes (3)

• Change in Stool Form

  Change in stool form from baseline, as determined from stool diary data comparing Rifaximin alone vs rifaximin and NAC The Bristol Stool Chart, the minimum value is 1 (means constipation) and maximum value is 7 (means diarrhea). The change between two time points is reported baseline and 4 weeks after cessation of treatment (at 6 weeks)

  value at 6 weeks minus value at baseline

• Change in Abdominal Pain

  Change in severity of abdominal pain from baseline, as determined from weekly average visual analog scale (VAS) scores, relative to Rifaximin alone. VAS scores allows subject to choose 0 for "no pain" to 100 "pain as bad as it could possibly be". The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 "no pain" and 100 "pain as bad as it could possibly be" The change between two time points is reported baseline and 4 weeks after cessation of treatment (at 6 weeks)

  value at 6 weeks minus value at baseline

• Change in Stool Frequency

  Change in stool frequency from baseline, as determined from diary data comparing Rifaximin alone vs Rifaximin and NAC determined from daily stool diary data The change in bowel movements/day between two time points is reported baseline and 4 weeks after cessation of treatment (at 6 weeks)

  value at 6 weeks minus value at baseline

Study Arms (3)

Standard dose for IBS-D

ACTIVE COMPARATOR

Rifaximin 550 mg

Drug: Rifaximin

Traveler's diarrhea dose + placebo

PLACEBO COMPARATOR

Rifaximin 200 mg + placebo

Drug: Rifaximin; Drug: Placebo

Traveler's diarrhea dose + NAC

EXPERIMENTAL

Rifaximin 200 mg plus N-acetylcysteine (NAC) 600 mg days

Drug: Rifaximin; Drug: N-acetylcysteine

Interventions

Rifaximin DRUG

Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

Also known as: xifaxan

Standard dose for IBS-D; Traveler's diarrhea dose + NAC; Traveler's diarrhea dose + placebo

N-acetylcysteine DRUG

N-acetylcysteine (NAC) is a clinically approved mucolytic agent.

Also known as: NAC

Traveler's diarrhea dose + NAC

Placebo DRUG

An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.

Traveler's diarrhea dose + placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• 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:
• 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".

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Bausch Health Ireland Limited: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

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• Villanueva-Millan MJ, Leite G, Wang J, Morales W, Parodi G, Pimentel ML, Barlow GM, Mathur R, Rezaie A, Sanchez M, Ayyad S, Cohrs D, Chang C, Rashid M, Hosseini A, Fiorentino A, Weitsman S, Chuang B, Chang B, Pichetshote N, Pimentel M. Methanogens and Hydrogen Sulfide Producing Bacteria Guide Distinct Gut Microbe Profiles and Irritable Bowel Syndrome Subtypes. Am J Gastroenterol. 2022 Dec 1;117(12):2055-2066. doi: 10.14309/ajg.0000000000001997. Epub 2022 Sep 6.

  PMID: 36114762 DERIVED

• Pimentel M, Mathur R, Wang J, Chang C, Hosseini A, Fiorentino A, Rashid M, Pichetshote N, Basseri B, Treyzon L, Chang B, Leite G, Morales W, Weitsman S, Kraus A, Rezaie A. A Smartphone Application Using Artificial Intelligence Is Superior To Subject Self-Reporting When Assessing Stool Form. Am J Gastroenterol. 2022 Jul 1;117(7):1118-1124. doi: 10.14309/ajg.0000000000001723. Epub 2022 Mar 14.

  PMID: 35288511 DERIVED

MeSH Terms

Interventions

Rifaximin; Acetylcysteine

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Mohamad Rashid
• Organization: Cedars-Sinai Medical Center

mastprogram@cshs.org

310.423.7302

Study Officials

• Mark Pimentel, MD

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GI Motility Clinic

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 21, 2020
• Study Start: November 13, 2020
• Primary Completion: August 31, 2021
• Study Completion: October 30, 2022
• Last Updated: March 28, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-03

Locations

US (1)