Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 treatment of Small intestinal bacterial overgrowth (SIBO).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bradley A. Connor, M.D.; Bradley Connor
• Treatments: Rifamycin SV; Rifamycins

Criteria

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.