WithdrawnEarly Phase 1

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

Stopped: PI no longer in practice.

United States0Started 2017-12-07

Plain-language 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.

Who can participate

Age range

19 Years – 84 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lactulose Breath Test

Timeframe: 8 weeks

Trial details

NCT IDNCT03420976

SponsorAtrium Innovations

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-30

View on ClinicalTrials.gov More Small Intestinal Bacterial Overgrowth trials