Gastrointestinal Disease, Gastrointestinal Infection, Small Intestinal Bacterial Overgrowth
Conditions
Brief 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).
Interventions
DRUGAEMCOLO (Rifamycin SV MMX)
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.
Sponsors
Bradley Connor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the change of an abnormal breath test followed by a regimen of AEMCOLO | 1 month after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the change in clinical symptoms followed by a regimen of AEMCOLO | Daily survey during and after treatment for 2 months and follow up at 3 months | 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. |
Countries
United States
Outcome results
None listed