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

A Randomized Open Label Trial Evaluating the Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

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 Overview

• Status: Enrolling by invitation
• Conditions: Gastrointestinal Disease; Small Intestinal Bacterial Overgrowth; Gastrointestinal Infection
• Intervention / Treatment: Drug: AEMCOLO (Rifamycin SV MMX)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • The New York Center for Travel and Tropical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1st regimen; 15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg two tablets to take twice daily for 14 days (56 Tablets)	Drug: AEMCOLO (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.
Experimental: 2nd regimen; 15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg tablets to take two tablets three times daily for 14 days (84 Tablets).	Drug: AEMCOLO (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Daily survey during and after treatment for 2 months and follow up at 3 months

Collaborators and Investigators

• Sponsor: Bradley Connor

Publications and helpful links

General Publications

• Pimentel M, Chow EJ, Lin HC. Normalization of lactulose breath testing correlates with symptom improvement in irritable bowel syndrome. a double-blind, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):412-9. doi: 10.1111/j.1572-0241.2003.07234.x.
• Dukowicz AC, Lacy BE, Levine GM. Small intestinal bacterial overgrowth: a comprehensive review. Gastroenterol Hepatol (N Y). 2007 Feb;3(2):112-22.
• Quigley EM, Abu-Shanab A. Small intestinal bacterial overgrowth. Infect Dis Clin North Am. 2010 Dec;24(4):943-59, viii-ix. doi: 10.1016/j.idc.2010.07.007.
• Sachdev AH, Pimentel M. Gastrointestinal bacterial overgrowth: pathogenesis and clinical significance. Ther Adv Chronic Dis. 2013 Sep;4(5):223-31. doi: 10.1177/2040622313496126.
• Shah SC, Day LW, Somsouk M, Sewell JL. Meta-analysis: antibiotic therapy for small intestinal bacterial overgrowth. Aliment Pharmacol Ther. 2013 Oct;38(8):925-34. doi: 10.1111/apt.12479. Epub 2013 Sep 4.
• Pimentel M, Chang C, Chua KS, Mirocha J, DiBaise J, Rao S, Amichai M. Antibiotic treatment of constipation-predominant irritable bowel syndrome. Dig Dis Sci. 2014 Jun;59(6):1278-85. doi: 10.1007/s10620-014-3157-8. Epub 2014 May 1.
• Gatta L, Scarpignato C. Systematic review with meta-analysis: rifaximin is effective and safe for the treatment of small intestine bacterial overgrowth. Aliment Pharmacol Ther. 2017 Mar;45(5):604-616. doi: 10.1111/apt.13928. Epub 2017 Jan 12.
• Rezaie A, Buresi M, Lembo A, Lin H, McCallum R, Rao S, Schmulson M, Valdovinos M, Zakko S, Pimentel M. Hydrogen and Methane-Based Breath Testing in Gastrointestinal Disorders: The North American Consensus. Am J Gastroenterol. 2017 May;112(5):775-784. doi: 10.1038/ajg.2017.46. Epub 2017 Mar 21.
• Furnari M, Parodi A, Gemignani L, Giannini EG, Marenco S, Savarino E, Assandri L, Fazio V, Bonfanti D, Inferrera S, Savarino V. Clinical trial: the combination of rifaximin with partially hydrolysed guar gum is more effective than rifaximin alone in eradicating small intestinal bacterial overgrowth. Aliment Pharmacol Ther. 2010 Oct;32(8):1000-6. doi: 10.1111/j.1365-2036.2010.04436.x. Epub 2010 Aug 18.
• Ghoshal UC, Ghoshal U, Das K, Misra A. Utility of hydrogen breath tests in diagnosis of small intestinal bacterial overgrowth in malabsorption syndrome and its relationship with oro-cecal transit time. Indian J Gastroenterol. 2006 Jan-Feb;25(1):6-10.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Anti-Infective Agents; Antirheumatic Agents; Anti-Bacterial Agents; Rifamycins; Rifamycin SV
• Other Study ID Numbers: MAS 0519-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No