Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
Purpose
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 treatment of Small intestinal bacterial overgrowth (SIBO).
Conditions
- Small Intestinal Bacterial Overgrowth
- Gastrointestinal Disease
- Gastrointestinal Infection
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Symptoms compatible with SIBO - A positive breath test for either hydrogen predominant, methane predominant or mixed SIBO
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 1st regimen |
15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg two tablets to take twice daily for 14 days (56 Tablets) |
|
|
Experimental 2nd regimen |
15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg tablets to take two tablets three times daily for 14 days (84 Tablets). |
|
Recruiting Locations
More Details
- NCT ID
- NCT04501380
- Status
- Unknown status
- Sponsor
- Bradley Connor