Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03420976 |
Other study ID # |
SIBO-ATRGM2017 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
December 7, 2017 |
Est. completion date |
February 1, 2019 |
Study information
Verified date |
January 2021 |
Source |
Atrium Innovations |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Study Synopsis
This pilot study will determine the efficacy of a novel supplement protocol and low FODMAP
diet for the treatment of small intestinal bacterial overgrowth (SIBO). The study will
operate as a prospective, open label investigation, with an estimated sample size of 10
patients.
Patients diagnosed with SIBO by Dr. Nathan Morris, MD at Good Medicine Clinic (Oxford, Ohio)
will be offered the opportunity to enroll in this study, if inclusion and exclusion criteria
are met upon initial diagnosis. No control group will be assigned.
The diagnosis of SIBO will be determined via assessment of clinical symptoms and the results
of a lactulose breath test. After administration of the supplement therapy and adherence to a
low FODMAP diet (8 weeks), the lactulose breath test will be repeated and symptoms
re-assessed by Dr. Morris. The post-treatment lactulose breath test and all supplements in
the protocol will be provided free-of-charge to enrolled patients. In addition, enrolled
patients will not be billed for the mid-treatment office visit. Patient and/or patient
insurance will be responsible for all other expenses, including but not limited to the
initial breath test, all other office visits and travel.
Description:
Background
Small intestinal bacterial overgrowth (SIBO) is a category of gastrointestinal infection,
characterized by an increased concentration (>100,000 CFU/mL proximal jejunal fluid) of
bacteria in the small intestine. Symptoms of SIBO commonly afflict the gastrointestinal tract
and include but are not limited to: abdominal pain, discomfort, bloating, cramping,
flatulence, diarrhea, constipation, eructation, and low serum B12.
SIBO is believed to be severely under diagnosed and is associated with numerous comorbid
conditions including irritable bowel syndrome, diabetes mellitus and hypothyroidism.
Small-bowel aspiration (SBA) or breath tests are used to aid in the diagnosis of SIBO.
Glucose or lactulose breath tests are more commonly performed, due to the cost and invasive
nature of SBA.
Treatment of SIBO frequently consists of antibiotic therapy. Rifaxamin is a poorly absorbed
antibiotic with bacteriocidal activity against enteropathogens that is widely prescribed for
the treatment of SIBO. However, both patients and practitioners frequently turn to
complementary and alternative treatment options, due to the adverse effects associated with
antibiotic use and the recurrent nature of SIBO. In 2014, a retrospective study (Chedid et
al.) found that the efficacy of a particular herbal therapy was comparable to Rifaxamin.
However, both treatment options demonstrated a response rate of less than 50%. This
investigation will test a more comprehensive, supplement-based therapy in hopes of achieving
a greater response rate in patients diagnosed with SIBO.
Objectives
This investigation aims to determine the efficacy of a supplement protocol in combination
with a low FODMAP diet for the treatment of SIBO.
Patient Selection
Patients diagnosed with SIBO at Dr. Morris' clinic will be offered the opportunity to enroll
in this study as a theoretical treatment option for SIBO. Other treatment options will be
discussed with the patient. Enrolled patients must satisfy the following inclusion and
exclusion criteria:
Study Procedures
The supplement protocol is designed to take 8 weeks. Due to the delay in receiving and
interpreting test results, the investigation, in its entirety, is estimated to take 12 weeks.
Visit -1 Dr. Morris will assess patient history and symptoms, at his facility in Oxford,
Ohio. If suggestive of SIBO, a lactulose breath test will be prescribed. Additional testing
may be performed, at the discretion of Dr. Morris, to aid in the initial diagnosis of the
patient.
Visit 0 Dr. Morris will assess the results of the breath test and confirm or deny the
diagnosis of SIBO. Treatment options for SIBO will be discussed, and the patient will be made
aware of this investigation as a theoretical treatment option. Patient eligibility will be
determined by completion of the the Patient Eligibility Checklist for each patient. All
female patients will be asked to complete a urine pregnancy test to confirm pregnancy status.
Eligible patients will be asked to review and sign the Informed Consent document. Carman
Clark (Medical Assistant at Good Medicine) will be available to discuss patient consent and
confidentiality. Enrolled patients will be asked to complete a baseline Medical Symptom
Questionnaire. Afterwards, Ms. Clark will review the supplement therapy and low FODMAP diet.
Patients will then be provided with all supplements necessary to complete the investigation.
Patients will be asked to discontinue all other supplements during the study. No wash out
period is required. Prescription medications, over-the-counter medications and/or supplements
deemed medically necessary by the patient's primary care physician and/or Dr. Morris may be
continued.
Visit 1 will occur approximately 4 weeks after the patient begins the supplement protocol.
Patients will be asked to report their compliancy with the supplement protocol and low FODMAP
diet and describe adverse effects. Patients will complete the Medical Symptom Questionnaire,
be provided with the post-treatment lactulose breath test kit and instructed to perform the
test within 2 weeks of completing the supplement therapy.
Visit 2 will occur after the results of the post-treatment breath test are available. Dr.
Morris will interpret the results of the second breath test. Patients will again be asked to
complete the Medical Symptom Questionnaire, report compliance with the supplement protocol
and low FODMAP diet, and describe any adverse effects. Further treatment options will be
discussed if necessary; follow-up treatment will be outside the scope of this investigation.
Risk/Safety Information
This study presents a risk in the form of adverse reactions to ingredients in the supplement
therapy. Patient risk will be minimized by excluding patients who may respond poorly to the
supplement therapy or testing procedures from the study, i.e., by abiding by the
aforementioned patient enrollment exclusion criteria.
Monitoring/Reporting
Patients may report adverse events to Good Medicine during scheduled office visits or by
phone during office hours. If serious or life-threatening side effects arise, patients are
instructed to call 911. Possible side effects include but are not limited to: diarrhea,
constipation, nausea, vomiting, bloating or headache. When necessary, Dr. Morris or Ms. Clark
will communicate with patients outside the office by phone. Medical guidance will be provided
as necessary. Adverse events will be recorded in confidential patient files.
Study Oversight
This study will be terminated if one-half or more of enrolled patients withdraw due to
adverse events. Dr. Morris and Dr. Kelly Heim (Senior Director, Scientific Affairs at Atrium
Innovations) will monitor, determine the need for and facilitate the termination of the
study. Direct access to study related data will be made available for monitoring, auditing,
IRB review and regulatory inspection.