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Crohn's DiseasePhase 2NCT00603616

Induction of Clinical Response Using Rifaximin in Crohn's Disease

A Phase 2 study testing Rifaximin in people with Crohn's Disease, run by Scott Lee at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Crohn's Disease
What is being tested?
Rifaximin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited States
Study dates
Nov 2008to 3 Nov 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects, 18 to 80 years of age, inclusive, that can themselves provide written, informed consent and authorization of use of protected health information prior to any study-related procedures and who are, in the opinion of the investigator(s), likely to comply with all the requirements of the study
  • Subjects must have a prior diagnosis of CD established by endoscopy and clinical parameters as determined by the investigator(s) for at least 3 months prior to randomization
  • Subjects must be able to participate in all required follow-up visits and fill out all related documentation (e.g. symptom diary)
  • Subjects currently with moderately active disease defined as a CDAI 250-450
  • Concomitant medications:
  • If subjects are taking sulfasalazine or 5-ASA products prior to entry, the dose must be stable for at least 4 weeks prior to the randomization
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  • If subjects are on azathioprine, 6-mercaptopurine, or methotrexate, they will have had to be on a stable dosage for at least 8 weeks
  • Subjects are allowed to be on corticosteroids at a dose equivalent to 20 mg or less of prednisone, IF the dose has been stable for a minimum of 2 weeks. Steroids must be held stable throughout the induction portion of the study. The maximum dose of budesonide must not exceed 9mg per day and must also have been stable for a minimum of 2 weeks.
  • No oral or intravenous antibiotics within 4 weeks prior to randomization
  • No current or past use of biological treatment within 6 weeks of randomization into study (e.g. infliximab)
  • If subjects have previously been on any of the above products but are no longer taking them, they should not have received any of the relevant therapeutic products within 4 weeks prior to randomization
  • No other experimental or non-FDA approved medications are allowed. If the subject has previously been on an experimental therapy, they must have not received the therapy within the prior 8 weeks prior to randomization
  • Subjects on concomitant medications for CD will not be allowed to change dosages during the study
  • If subjects are at increased risk of colorectal cancer (defined as having an 8-year history of pan-colitis or 12 year history of left sided colitis), they will need to have undergone a colonoscopy with pan-colonic surveillance biopsies within 2 years of the screening visit. The biopsies must be negative for dysplasia
  • Female or male subjects who are surgically sterilized or who are prepared to and agree to practice a double-barrier form of birth control from the screening visit through 30 days (females) and 30 days (males), respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal are also eligible to participate in the study

Who cannot join

  • Evidence of active infection which may include any of the following
  • Febrile ( > 38.5ºC)
  • Positive blood culture within 2 weeks prior to randomization
  • Evidence of toxic megacolon or abscess
  • Positive stool culture for enteric pathogens, pathogenic ova or parasite, or a positive assay for C. difficile toxin at screening
  • Subjects with CDAI > 450
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  • Any current use or use within the last 8 weeks of an investigational drug
  • Current or past use (within past 12 wks) of biological treatment
  • Current or use within the last 4 weeks of any oral or intravenous antibiotic
  • Anticipated increased dosage of any medication to treat CD
  • Anticipated need for surgery within 12 weeks
  • Known obstructive diseases of the gastrointestinal system
  • Medical conditions requiring in-patient hospitalization
  • Proctocolectomy, total colectomy, ileostomy, or stoma
  • Severe cardiopulmonary disease:
  • Congestive heart failure (NYHA Class III or IV)
  • Severe cardiovascular or peripheral vascular disease
  • Myocardial infarction, percutaneous coronary intervention, or bypass surgery within the past 6 months
  • Significant liver disease:
  • Levels of SGOT [AST], SGPT [ALT], or alkaline phosphatase > 2.5x the upper limit of the normal range for the laboratory performing test
  • History of cirrhosis
  • Renal insufficiency, defined as serum creatinine > 150% of the upper limit of the normal range for the laboratory performing the test
  • Abnormal hematology parameters defined as severe anemia with hemoglobin < 8.5 g/dL and/or white blood cell count of < 3,500/ul
  • Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
  • History of dysplasia or carcinoma of the colon
  • Pregnant, lactating, or planning to become pregnant during the course of the investigational study
  • Known history of allergic reaction to rifaximin or allergy to any of the rifamycin antimicrobial agents (which include rifampin, rifabutin, and rifapentine)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington Medical Center

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Randomized, Prospective, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of Rifaximin for the Treatment of Moderate to Severe Crohn's Disease

Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces.

The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.

Read the detailed description

Inflammatory bowel disease (IBD) is a debilitating chronic inflammatory disease conventionally categorized into Crohn's disease (CD) and Ulcerative Colitis (UC). CD affects nearly 630,000 people in North America with up to 50,000 new people being diagnosed every year. It is a chronic debilitating disease characterized by abdominal pain, malnutrition, bloody diarrhea, fistula formation, intestinal perforations and strictures, and even extra-intestinal manifestations such as joint pains and skin rashes. Nearly 80% of people with CD will need surgical treatment at some point in their disease process. The majority of CD subjects are diagnosed in young adulthood thereby subjecting them to many decades of discomfort and medical intervention.

Antibiotics have been used to treat CD with variable response rates. The basis for antibiotic therapy is that breakdown of the integrity of the mucosal barrier in the gastrointestinal (GI) tract leads to a heightened inflammatory response to commensurate luminal bacteria. By changing the composition or bacterial load in the intestinal lumen, it may be possible to alter the immune response. Ciprofloxacin (Cipro) and metronidazole (Flagyl) are the best studied antibiotics that have shown efficacy, but the effect is temporal and long term use can lead to serious side effects. Rifaximin is a recent FDA approved antibiotic with broad spectrum of activity, excellent safety profile, and minimal absorption from the GI tract. Open label and small studies in IBD subjects show response rates up to 80% in CD subjects. These studies were limited however in that they were not randomized placebo controlled trials.

The investigators propose to conduct a randomized placebo controlled crossover trial of rifaximin in CD subjects to assess initial clinical response compared to placebo.

Conditions
Crohn's Disease
Being tested
Placebo Comparator, Rifaximin
Keywords
Inflammatory Bowel Disease, Crohn disease, Crohn's disease, Rifaximin
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo ComparatorDrug

    Matching oral placebo pills to be taken twice daily for a total of 8 weeks

  • RifaximinDrug

    Also called Xifaxan

    Oral rifaximin 550mg to be taken twice daily for a total of 8 weeks

Study groups in NCT00603616
Study groupRoleWhat they receive
1Placebo comparatorPlacebo pills
Receives: Drug: Placebo Comparator
2Active comparatorRifaximin
Receives: Drug: Rifaximin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the efficacy of rifaximin 550 mg bid compared to placebo in achieving clinical response in moderate to severe Crohn's Disease (CD) subjects as determined by a > 100 point decrease in the Crohn's Disease Activity Index (CDAI)

    Measured: 8 weeks

Secondary outcomes (5)

  1. Evaluate the efficacy of rifaximin compared to placebo at inducing clinical remission in CD subjects

    Measured: 8 weeks

  2. Evaluate the safety profile of rifaximin in subjects with active CD

    Measured: 16 weeks for those subjects who do not cross over, 32 weeks for those who do cross over

  3. Evaluate the effect rifaximin has on the quality of life in subjects with CD compared to placebo

    Measured: 8 weeks

  4. Evaluate if there are any clinical parameters which might predict response to rifaximin

    Measured: 8 weeks

  5. Compare mean changes in CDAI scores between rifaximin and placebo treated subjects

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2008 (estimated)
  2. Study startNov 2008
  3. Primary completion3 Nov 2020
  4. Study completion3 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00603616
Sponsor's protocol ID
32871
Other IDs
32871
Status last verified
Dec 2021
First submitted
16 Jan 2008
Last updated
9 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rifaximin in people with Crohn's Disease, run by Scott Lee at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy of rifaximin 550 mg bid compared to placebo in achieving clinical response in moderate to severe Crohn's Disease (CD) subjects as determined by a > 100 point decrease in the Crohn's Disease Activity Index (CDAI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00603616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.

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