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

Phase 2

• Conditions: Small Intestinal Bacterial Overgrowth; Gastrointestinal Disease; Gastrointestinal Infection
• Interventions: Drug: AEMCOLO (Rifamycin SV MMX)

• Registration Number: NCT04501380
• Lead Sponsor: Bradley Connor

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-30
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2nd regimen	AEMCOLO (Rifamycin SV MMX)	15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg tablets to take two tablets three times daily for 14 days (84 Tablets).
1st regimen	AEMCOLO (Rifamycin SV MMX)	15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg two tablets to take twice daily for 14 days (56 Tablets)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The New York Center for Travel and Tropical Medicine; 🇺🇸 New York, New York, United States