Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
A Randomized Open Label Trial Evaluating the Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
StatusEnrolling by invitation
Indication/ConditionSmall Intestinal Bacterial Overgrowth Gastrointestinal Disease Gastrointestinal Infection
Intervention/TreatmentAEMCOLO (Rifamycin SV MMX)
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).
Participants will be issued a patient kit containing AEMCOLO (Rifamycin SV MMX) 194 mg tablets for the 1st or the 2nd treatment regimen in a random order.
15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg two tablets to take twice daily for 14 days (56 Tablets)
15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg tablets to take two tablets three times daily for 14 days (84 Tablets).
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.