Status:
UNKNOWN
Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
Lead Sponsor:
Bradley Connor
Conditions:
Small Intestinal Bacterial Overgrowth
Gastrointestinal Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Open label interventional randomized pilot study utilizing two dosing regimens of AEMCOLO. The goal of this study is to evaluate effectiveness of a novel antibiotic, AEMCOLO (Rifamycin SV MMX) in the ...
Eligibility Criteria
Inclusion
- Symptoms compatible with SIBO
- A positive breath test for either hydrogen predominant, methane predominant or mixed SIBO
Exclusion
- History of diabetes mellitus,
- Diarrhea predominant irritable bowel syndrome (IBS-D),
- Symptomatic bowel obstruction,
- Diverticulitis and/ or adhesions,
- Autoimmune disorder,
- Immunosuppression by medication or disease,
- Pregnant or breast feeding,
- The use of antibiotics, probiotics or prebiotics within the previous 30 days,
- Known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the components of AEMCOLO.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04501380
Start Date
June 30 2020
End Date
December 30 2022
Last Update
May 5 2022
Active Locations (1)
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1
The New York Center for Travel and Tropical Medicine
New York, New York, United States, 10022