NCT04501380

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

2.5 years

First QC Date

July 28, 2020

Last Update Submit

April 29, 2022

Conditions

Small Intestinal Bacterial OvergrowthGastrointestinal DiseaseGastrointestinal Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

1st regimen

EXPERIMENTAL

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)

2nd regimen

EXPERIMENTAL

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)

Interventions

AEMCOLO (Rifamycin SV MMX)DRUG

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.

1st regimen2nd regimen

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms compatible with SIBO
  • A positive breath test for either hydrogen predominant, methane predominant or mixed SIBO

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New York Center for Travel and Tropical Medicine

New York, New York, 10022, United States

Location

Related Publications (11)

  • Dukowicz AC, Lacy BE, Levine GM. Small intestinal bacterial overgrowth: a comprehensive review. Gastroenterol Hepatol (N Y). 2007 Feb;3(2):112-22.

    PMID: 21960820BACKGROUND

  • 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.

    PMID: 20937459BACKGROUND

  • 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.

    PMID: 23997926BACKGROUND

  • 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.

    PMID: 24004101BACKGROUND

  • 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.

    PMID: 24788320BACKGROUND

  • 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.

    PMID: 28078798BACKGROUND

  • 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.

    PMID: 28323273BACKGROUND

  • 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.

    PMID: 12591062BACKGROUND

  • 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.

    PMID: 20937045BACKGROUND

  • 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.

    PMID: 16567886BACKGROUND

  • Connor BA, Rogova M, Garcia J, Gardner M, Waraich C, Averill V. A randomized open label pilot study evaluating the efficacy of two dosing regimens of rifamycin SV MMX in the treatment of small intestinal bacterial overgrowth. BMC Gastroenterol. 2025 Apr 3;25(1):219. doi: 10.1186/s12876-025-03804-3.

    PMID: 40181268DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

rifamycin SV

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 6, 2020

Study Start

June 30, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)