Clinical trial NCT04501380: Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
Official title: A Randomized Open Label Trial Evaluating the Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Intestinal Bacterial Overgrowth
Gastrointestinal Disease
Gastrointestinal Infection
Lead sponsor: The New York Center for Travel and Tropical Medicine
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: To assess the change of an abnormal breath test followed by a regimen of AEMCOLO
timeFrame: 1 month after treatment
Secondary outcomes:
measure: To evaluate the change in clinical symptoms followed by a regimen of AEMCOLO
timeFrame: Daily survey during and after treatment for 2 months and follow up at 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Center for Travel and Tropical Medicine
state: New York
Study officials:
References:
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