Irritable Bowel Syndrome With Diarrhea (IBS-D) Rifaximin Re-Treatment Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Diarrhea

In brief

This study will evaluate the effectiveness and safety of repeat treatment with rifaximin 550 mg three times a day in patients with IBS with diarrhea who respond to initial treatment of rifaximin 550 mg three times a day.

Key facts

Study ID

NCT01543178

Run by

Bausch Health Americas, Inc.

People needed

2583

Starts

2012-02-01

Expected to finish

2014-06-01

Last updated by the study team

2017-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• IBS confirmed by Rome III diagnostic criteria.
• At least 18 years of age.
• Colonoscopy within the past 10 years to rule out inflammatory bowel disease; or flexible sigmoidoscopy if < 50 years of age or previous colonoscopy > 10 years prior.
• Willing to maintain a stable diet. including vitamins, supplements, and nutraceuticals.

You may not qualify if…

• Diabetes (Type 1 or 2).
• Lactose intolerance and not controlled by a lactose-free diet.
• Pregnant or planning to become pregnant or is lactating.
• History of HIV or hepatitis B or C.
• Participation in investigational study within past 30 days.
• Taking rifaximin or any other antibiotic within past 60 days.
• Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition.
• History of GI surgery.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Dothan, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Selma, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Sherwood, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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