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

NCT03420976 | Withdrawn Early Phase 1 DMC

• 1 other identifier: SIBO-ATRGM2017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Intestinal Bacterial Overgrowth

Keywords

Small Intestinal Bacterial Overgrowth; SIBO

Outcome Measures

Primary Outcomes (1)

• Lactulose Breath Test

  Clinically and/or statistically significant reduction in hydrogen and methane levels following lactulose ingestion

  8 weeks

Secondary Outcomes (1)

• Symptom Survey

  8 weeks

Study Arms (1)

Novel Supplement-based Therapy

EXPERIMENTAL

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

Interventions

Novel Supplement Based Therapy DIETARY_SUPPLEMENT

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

Novel Supplement-based Therapy

Eligibility Criteria

• Age: 19 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A positive diagnosis of SIBO, which will be defined by:
• presentation of the aforementioned symptoms and
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Atrium Innovations: lead
• Dr. Nathan Morris, MD: collaborator
• Genova Diagnostics: collaborator

Study Sites (1)

Good Medicine

Oxford, Ohio, 45056, United States

Location

Study Officials

• Nathan Morris, MD

  Good Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 5, 2018
• Study Start: December 7, 2017
• Primary Completion: January 30, 2019
• Study Completion: February 1, 2019
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

US (1)