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

Bradley Connor30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Small Intestinal Bacterial Overgrowth Gastrointestinal Disease Gastrointestinal Infection

Interventions

AEMCOLO (Rifamycin SV MMX)DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The New York Center for Travel and Tropical Medicine

New York, New York, United States

Outcomes

Primary Outcomes

To assess the change of an abnormal breath test followed by a regimen of AEMCOLO

A hydrogen and methane breath test will be used to measure presence or absence of Small Intestinal Bacterial Overgrowth (SIBO). Study subjects will be assessed for the presence of SIBO. A rise of ≥ 20 ppm from baseline in hydrogen by 90 minutes or a level of ≥ 10 ppm for methane is considered a positive test for SIBO on a breath test. When combining both hydrogen and methane in the breath test, a rise of ≥ 15 ppm from baseline at 90 minutes is considered a positive test for SIBO. We plan to measure these parameters at baseline and after completion of study medication.

Time frame: 1 month after treatment

Secondary Outcomes

To evaluate the change in clinical symptoms followed by a regimen of AEMCOLO

There will be a measurement of symptoms as assessed by a validated visual analogue scale (VAS) questionnaire. Symptoms will be assessed on a 0-4 scale to generate a maximum score of 20 and a minimum score of 0. The change in this composite score will be compared between two treatment arms at baseline, after completion of study medication, and 3 months after treatment. A positive clinical response defined as a 50% reduction in CS will be assessed. This method of analysis closely follows the multinational consensus recommended guidelines for data analysis in IBS clinical studies.

Time frame: Daily survey during and after treatment for 2 months and follow up at 3 months

Data from ClinicalTrials.gov

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