Small Intestinal Bacterial OvergrowthPhase 4NCT02458781
Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth
A Phase 4 study testing Metronidazole and Ciprofloxacin in people with Small Intestinal Bacterial Overgrowth, run by San Antonio Military Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth
- What is being tested?
- Metronidazole and Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ciprofloxacin and Metronidazole
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).
Read the 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.
- Conditions
- Small Intestinal Bacterial Overgrowth
- Being tested
- Metronidazole, Ciprofloxacin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called flagyl, metro
Metronidazole 500mg given twice daily for 14 days
CiprofloxacinDrug
Also called cipro, fluoroquinolone
Ciprofloxacin 500mg given twice daily for 14 days
PlaceboDrug
Also called sugar pill
Placebo given twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo.
Measured: 2 weeks
Secondary outcomes (3)
Gastrointestinal symptoms based on questionnaire
Measured: Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months
Disease relapse rate of SIBO after treatment success
Measured: Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months
Time interval between treatment success and recurrence of SIBO
Measured: Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial OvergrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Antonio Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Karin S. Gilkison, San Antonio Military Medical Center
- Investigators
- Karin S Gilkison, MD, MPH, Principal investigator, Gastroenterology Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458781
- Sponsor's protocol ID
- 398092-1
- Status last verified
- May 2015
- First submitted
- 10 Apr 2015
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ciprofloxacin and Metronidazole
- ClinicalTrials.gov ID
- NCT02458781
- Acronym / sponsor ID
- 398092-1
- Conditions
- Small Intestinal Bacterial Overgrowth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- San Antonio Military Medical CenterUS federal agency
- Study start
- Jan 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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. |
| Ciprofloxacin | Active comparator | Drug: CiprofloxacinCiprofloxacin 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. |
| Metronidazole | Active comparator | Drug: MetronidazoleMetronidazole 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetronidazoleAlso: flagyl, metroMetronidazole 500mg given twice daily for 14 days | Drug | Metronidazole |
| CiprofloxacinAlso: cipro, fluoroquinoloneCiprofloxacin 500mg given twice daily for 14 days | Drug | Ciprofloxacin |
| PlaceboAlso: sugar pillPlacebo given twice daily for 14 days | Drug | Placebo |
Primary outcome
Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo.
Time frame: 2 weeks
3 secondary outcomes
Gastrointestinal symptoms based on questionnaire
Time frame: Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months
Disease relapse rate of SIBO after treatment success
Time frame: Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months
Time interval between treatment success and recurrence of SIBO
Time frame: Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin S Gilkison, MD, MPH principal investigator
Gastroenterology Fellow
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole and Ciprofloxacin in people with Small Intestinal Bacterial Overgrowth, run by San Antonio Military Medical Center.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2015.