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

Primary Purpose

Small Intestinal Bacterial Overgrowth, Gastrointestinal Disease, Gastrointestinal Infection

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AEMCOLO (Rifamycin SV MMX)
Sponsored by
Bradley Connor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Intestinal Bacterial Overgrowth

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The New York Center for Travel and Tropical Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1st regimen

2nd regimen

Arm Description

15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg two tablets to take twice daily for 14 days (56 Tablets)

15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg tablets to take two tablets three times daily for 14 days (84 Tablets).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 28, 2020
Last Updated
April 29, 2022
Sponsor
Bradley Connor
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1. Study Identification

Unique Protocol Identification Number
NCT04501380
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bradley Connor

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Intestinal Bacterial Overgrowth, Gastrointestinal Disease, Gastrointestinal Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1st regimen
Arm Type
Experimental
Arm Description
15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg two tablets to take twice daily for 14 days (56 Tablets)
Arm Title
2nd regimen
Arm Type
Experimental
Arm Description
15 patients will receive AEMCOLO (Rifamycin SV MMX) 194 mg tablets to take two tablets three times daily for 14 days (84 Tablets).
Intervention Type
Drug
Intervention Name(s)
AEMCOLO (Rifamycin SV MMX)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the change of an abnormal breath test followed by a regimen of AEMCOLO
Description
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 Outcome Measure Information:
Title
To evaluate the change in clinical symptoms followed by a regimen of AEMCOLO
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
The New York Center for Travel and Tropical Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21960820
Citation
Dukowicz AC, Lacy BE, Levine GM. Small intestinal bacterial overgrowth: a comprehensive review. Gastroenterol Hepatol (N Y). 2007 Feb;3(2):112-22.
Results Reference
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PubMed Identifier
20937459
Citation
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.
Results Reference
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PubMed Identifier
23997926
Citation
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.
Results Reference
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PubMed Identifier
24004101
Citation
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.
Results Reference
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PubMed Identifier
24788320
Citation
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.
Results Reference
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PubMed Identifier
28078798
Citation
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.
Results Reference
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PubMed Identifier
28323273
Citation
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.
Results Reference
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PubMed Identifier
12591062
Citation
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.
Results Reference
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PubMed Identifier
20937045
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Efficacy of AEMCOLO (Rifamycin SV MMX) in the Treatment of Small Intestinal Bacterial Overgrowth (SIBO)

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