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

Withdrawn before enrolling · Early Phase 1

Conditions studied: Small Intestinal Bacterial Overgrowth

In brief

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.

Key facts

Study ID

NCT03420976

Run by

Atrium Innovations

People needed

0

Starts

2017-12-07

Expected to finish

2019-02-01

Last updated by the study team

2021-01-12

Who can join

Age: 19 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Good Medicine — Oxford, Ohio, United States

Full record on ClinicalTrials.gov

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