Status:
WITHDRAWN
Novel Supplement-based Therapy for the Treatment of Small Intestinal Bacterial Overgrowth
Lead Sponsor:
Atrium Innovations
Collaborating Sponsors:
Dr. Nathan Morris, MD
Genova Diagnostics
Conditions:
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
19-84 years
Phase:
EARLY_PHASE1
Brief 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 operat...
Detailed 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 ...
Eligibility Criteria
Inclusion
- A positive diagnosis of SIBO, which will be defined by:
- presentation of the aforementioned symptoms and
- positive results of a lactulose breast test. Positive breath test results will be defined as an increase in hydrogen of 20 ppm or more and/or an increase in methane of 12 ppm or more compared to baseline by 90 minutes.
Exclusion
- Use of prescription antibiotics or antifungals within the past 4 weeks.
- Younger than 18 or older than 85 years of age.
- Pregnant or breastfeeding.
- Major drug-supplement interactions between essential medication and the proposed supplement therapy.
- A known allergy to one or more of the ingredients in the supplement therapy.
- Has been diagnosed and treated for SIBO within the past 6 months.
- Has undergone a colonoscopy or barium enema within the past 4 weeks.
- Has an allergy to lactulose. 9) Has diabetes mellitus.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03420976
Start Date
December 7 2017
End Date
February 1 2019
Last Update
January 12 2021
Active Locations (1)
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1
Good Medicine
Oxford, Ohio, United States, 45056