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Novel Supplement-based Therapy for the Treatment of Small Intestinal Bacterial Overgrowth

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ClinicalTrials.gov Identifier: NCT03420976
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Collaborators:
Dr. Nathan Morris, MD
Genova Diagnostics
Information provided by (Responsible Party):
Atrium Innovations

Brief Summary:

Study Synopsis

This pilot study will determine the efficacy of a novel supplement protocol and low FODMAP diet for the treatment of small intestinal bacterial overgrowth (SIBO). The study will operate as a prospective, open label investigation, with an estimated sample size of 10 patients.

Patients diagnosed with SIBO by Dr. Nathan Morris, MD at Good Medicine Clinic (Oxford, Ohio) will be offered the opportunity to enroll in this study, if inclusion and exclusion criteria are met upon initial diagnosis. No control group will be assigned.

The diagnosis of SIBO will be determined via assessment of clinical symptoms and the results of a lactulose breath test. After administration of the supplement therapy and adherence to a low FODMAP diet (8 weeks), the lactulose breath test will be repeated and symptoms re-assessed by Dr. Morris. The post-treatment lactulose breath test and all supplements in the protocol will be provided free-of-charge to enrolled patients. In addition, enrolled patients will not be billed for the mid-treatment office visit. Patient and/or patient insurance will be responsible for all other expenses, including but not limited to the initial breath test, all other office visits and travel.


Condition or disease Intervention/treatment Phase
Small Intestinal Bacterial Overgrowth Dietary Supplement: Novel Supplement Based Therapy Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Investigating a Novel Supplement-based Therapy for the Treatment of Small Intestinal Bacterial Overgrowth
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Novel Supplement-based Therapy

Low FODMAP diet + supplements outlined below:

Product Name: Liver-G.I. Detox Active Ingredients: Alpha lipoic acid, n-acetyl-l-cystine, turmeric root extract, milk thistle seed extract, broccoli sprout concentrate, artichoke leaf extract, taurine, glycine, l-glutamine, l-methionine, and chlorella.

Product Name: l-Glutamine Active Ingredients: l-glutamine

Product Name: MicroDefense Active Ingredients: berberine sulfate, olive leaf extract, sweet wormwood, clove bud powder, and grapefruit seed and fruit extract.

Product Name: A.C. Formulla II Active Ingredients: calcium and magnesium undecylenate, calcium and magnesium caprylate, bromelain, grapefruit seed and fruit extract, and berberine sulfate

Product Name: Probiotic-5 (Pure Encapsulations) Active Ingredients: Probiotic blend

Product Name: Digestive Enzymes Ultra with Betaine HCl Active Ingredients: Digestive enzyme blend and betaine HCl

Dietary Supplement: Novel Supplement Based Therapy

Supplements and Dosage:

Detox Support: Liver-G.I. Detox BID for 30 days GI Support: L-Glutamine Powder 2 scoops QD for 35 days Microbial Balance: MicroDefense 1 capsule QD for 49 days Microbial Balance: A.C. Formula II 2 capsules BID for 49 days Probiotic: Probiotic-5 1 capsule QD for 49 days Digestive Enzymes: Digestive Enzymes Ultra with Betaine HCl As needed up to 6 longer term





Primary Outcome Measures :
  1. Lactulose Breath Test [ Time Frame: 8 weeks ]
    Clinically and/or statistically significant reduction in hydrogen and methane levels following lactulose ingestion


Secondary Outcome Measures :
  1. Symptom Survey [ Time Frame: 8 weeks ]
    Patient reported remission or improvement of SIBO-related symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A positive diagnosis of SIBO, which will be defined by:

  1. presentation of the aforementioned symptoms and
  2. positive results of a lactulose breast test. Positive breath test results will be defined as an increase in hydrogen of 20 ppm or more and/or an increase in methane of 12 ppm or more compared to baseline by 90 minutes.

Exclusion Criteria:

  1. Use of prescription antibiotics or antifungals within the past 4 weeks.
  2. Younger than 18 or older than 85 years of age.
  3. Pregnant or breastfeeding.
  4. Major drug-supplement interactions between essential medication and the proposed supplement therapy.
  5. A known allergy to one or more of the ingredients in the supplement therapy.
  6. Has been diagnosed and treated for SIBO within the past 6 months.
  7. Has undergone a colonoscopy or barium enema within the past 4 weeks.
  8. Has an allergy to lactulose. 9) Has diabetes mellitus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420976


Contacts
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Contact: Paul Larkin 978-579-2357 plarkin@atrium-innovations.com
Contact: Kara Badgley, BS 513-273-9944 kbadgley@thisisgoodmedicine.com

Locations
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United States, Ohio
Good Medicine Recruiting
Oxford, Ohio, United States, 45056
Contact: Carman Clark    513-273-9944    ccclark@thisisgoodmedicine.com   
Principal Investigator: Dr. Nathan Morris, MD         
Sponsors and Collaborators
Atrium Innovations
Dr. Nathan Morris, MD
Genova Diagnostics
Investigators
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Principal Investigator: Nathan Morris, MD Good Medicine
  Study Documents (Full-Text)

Documents provided by Atrium Innovations:
Study Protocol  [PDF] May 3, 2017


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Responsible Party: Atrium Innovations
ClinicalTrials.gov Identifier: NCT03420976     History of Changes
Other Study ID Numbers: SIBO-ATRGM2017
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atrium Innovations:
Small Intestinal Bacterial Overgrowth
SIBO