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

Bradley Connor

Status and phase

Unknown

Phase 2

Conditions

Gastrointestinal Disease

Gastrointestinal Infection

Small Intestinal Bacterial Overgrowth

Treatments

Drug: AEMCOLO (Rifamycin SV MMX)

Study type

Interventional

Funder types

Other

Identifiers

NCT04501380

MAS 0519-1

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.