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Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02458781
Recruitment Status : Unknown
Verified May 2015 by Karin S. Gilkison, San Antonio Military Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : June 1, 2015
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Karin S. Gilkison, San Antonio Military Medical Center

Brief Summary:
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of ciprofloxacin versus metronidazole versus placebo in eradication of small intestinal bacterial overgrowth (SIBO).

Condition or disease Intervention/treatment Phase
Small Intestinal Bacterial Overgrowth Drug: Metronidazole Drug: Ciprofloxacin Drug: Placebo Phase 4

Detailed Description:
Approximately 180 study subjects with SIBO identified by positive glucose hydrogen breath (GHB) testing who meet inclusive and exclusive criteria will be randomized to receive either ciprofloxacin 500mg by mouth twice daily, metronidazole 500mg by mouth twice daily, or placebo by mouth twice daily. Subjects will complete a baseline symptom questionnaire and be treated for 14 days. Response will be assessed at end of treatment. The Gastrointestinal Symptom Rating Scale (GSRS) and GHB testing will be performed at the end of treatment. Subjects with a negative GHB at the end of treatment are considered as cured, or treatment success. Patients with treatment success will be reassessed for long-term response to treatment or disease recurrence at 30 days, 4 months, and 9 months using GHB. Symptoms will also be re-assessed at the 30 day, 4 month, and 9 month intervals with GSRS-IBS symptom questionnaire done prior to GHB testing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ciprofloxacin and Metronidazole
Study Start Date : January 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo

Placebo capsule:

To be provided by BAMC Pharmacy. It will be made and stored by BAMC pharmacy. The matching placebo will be a gelatin capsule filled with methylcellulose powder only. Patient will take 2 capsules two times a day for 14 days.

Drug: Placebo
Placebo given twice daily for 14 days
Other Name: sugar pill

Active Comparator: Ciprofloxacin

Ciprofloxacin 250mg capsule:

To be provided by BAMC pharmacy. It will be made and stored by BAMC Pharmacy. Ciprofloxacin 250mg tablet will be encapsulated with a gelatin capsule filled with methylcellulose. Patient will take 2 capsules of Ciprofloxacin 250mg two times a day for 14 days.

Drug: Ciprofloxacin
Ciprofloxacin 500mg given twice daily for 14 days
Other Names:
  • cipro
  • fluoroquinolone

Active Comparator: Metronidazole

Metronidazole 250mg capsule:

To be provided by BAMC pharmacy. It will be made and stored by BAMC Pharmacy. Metronidazole 250mg will be encapsulated with a gelatin capsule filled with methylcellulose. Patient will take 2 capsules of metronidazole 250mg two times a day for 14 days.

Drug: Metronidazole
Metronidazole 500mg given twice daily for 14 days
Other Names:
  • flagyl
  • metro




Primary Outcome Measures :
  1. Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Gastrointestinal symptoms based on questionnaire [ Time Frame: Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months ]
  2. Disease relapse rate of SIBO after treatment success [ Time Frame: Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months ]
  3. Time interval between treatment success and recurrence of SIBO [ Time Frame: Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients age greater than 18 who have been diagnosed with SIBO after a clinically indicated hydrogen breath test.
  • Patients with liver disease or liver cirrhosis will be included, as this particular group is at higher risk for developing SIBO, would potentially benefit from inclusion, and do not require dose adjustments with either study medication.
  • Patients on warfarin are not excluded, but INR will be uniformly recommended to be checked within 1 week of therapy initiation, as standard practice through the Coumadin clinic, for the potential effect on INR and increased risk of bleeding while on any antibiotic

Exclusion Criteria:

  • Patient age less than 18
  • Hypersensitivity to the antibiotics
  • Pregnancy or breast feeding
  • Patients who cannot consent for themselves
  • End stage renal disease defined as creatinine clearance <30 mL/min or on hemodialysis.
  • Patients who have taken antibiotics in the past 30 days
  • Laxatives, stool softeners, or bulk fiber in the last 7 days
  • Enemas or suppositories in the last 3 daysⱡ

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458781


Sponsors and Collaborators
San Antonio Military Medical Center
Investigators
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Principal Investigator: Karin S Gilkison, MD, MPH Gastroenterology Fellow

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Responsible Party: Karin S. Gilkison, Gastroenterology Fellow, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT02458781    
Other Study ID Numbers: 398092-1
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Metronidazole
Ciprofloxacin
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors