Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth

NCT02458781 | Unknown Phase 4 DMC

• 1 other identifier: 398092-1
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Small Intestinal Bacterial Overgrowth

Outcome Measures

Primary Outcomes (1)

• Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo.

  2 weeks

Secondary Outcomes (3)

• Gastrointestinal symptoms based on questionnaire

  Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months

• Disease relapse rate of SIBO after treatment success

  Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months

• Time interval between treatment success and recurrence of SIBO

  Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Ciprofloxacin

ACTIVE COMPARATOR

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

Metronidazole

ACTIVE COMPARATOR

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

Interventions

Metronidazole DRUG

Metronidazole 500mg given twice daily for 14 days

Also known as: flagyl, metro

Metronidazole

Ciprofloxacin DRUG

Ciprofloxacin 500mg given twice daily for 14 days

Also known as: cipro, fluoroquinolone

Ciprofloxacin

Placebo DRUG

Placebo given twice daily for 14 days

Also known as: sugar pill

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult patients age greater than 18 who have been diagnosed with SIBO after a clinically indicated hydrogen breath test.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Antonio Military Medical Center: lead

MeSH Terms

Interventions

Metronidazole; Ciprofloxacin; Fluoroquinolones; Sugars

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Study Officials

• Karin S Gilkison, MD, MPH

  Gastroenterology Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Fellow

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: June 1, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 1, 2015

Record last verified: 2015-05