Artemisia annua for hydrogen-type small intestinal bacterial overgrowth (SIBO)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a triple-blind, placebo-controlled, parallel-arm Phase 1/2 trial enrolling up to 32 adults with hydrogen-type SIBO in the Portland, Oregon area. Participants will take either 5 g/day of dried Artemisia annua leaf or a matching placebo for five weeks, with randomization stratified by symptom severity. Safety and tolerability will be monitored with biweekly blood tests, vital signs, and adverse event reporting, while symptom change will be tracked with validated questionnaires and two lactulose breath tests. Secondary and exploratory outcomes include symptom severity changes and hydrogen/methane breath test responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults 18 years of age or older
* IBS-SSS score \>175
* Meets North American Consensus criteria for H2 SIBO
* Willing to take Artecinua™ or placebo as a dietary supplement for 5 weeks
* Willing to have two lactulose breath tests and do the prep diet 24 hours before and fast overnight before the test
* Willing to have three blood drawstests and fast overnight before the draw
* Able to speak, read, and understand English
* Able to provide informed consent
* For individuals of child-bearing potential, willing to use an intrauterine device or two other concurrent forms of birth control to prevent pregnancy while enrolled

Exclusion Criteria:

* Use of antibiotic pharmaceuticals or supplements 14 days before baseline breath test
* Initiation of change in diet, medication, or supplement regime within 30 days
* Hospitalization within the past 3 months
* Women who are breastfeeding, pregnant, or planning pregnancy in the next 4 months
* Allergies to any of the ingredients in the study products.
* Individuals with chronic kidney or liver disease, cancer, colorectal disease and/or other rare disorders that at the discretion of the PI or Clinical \*Investigator may impact their safety or confound trial results
* The use of any high-risk medications with narrow therapeutic indices metabolized by CYP450 enzymes: Warfarin (CYP2C9), Tacrolimus/Cyclosporine (CYP3A4), Efavirenz (CYP2B6), and Codeine (CYP2D6).
* Drugs requiring activation for efficacy: Clopidogrel (CYP2C19), Codeine (CYP2D6), and Tamoxifen (CYP2D6) (citations).
* GFR: \<30 mL/min/1.73m²
* Hepatitis from any cause.
* Excessive alcohol use (\> seven drinks/week in women and \> fourteen in men).
* Hepatic (ALT, AST, bilirubin) and renal (creatinine, estimated GFR) parameters outside of normal range at screening.

Where it's running

• Helfgott Research Institute - National University of Natural Medicine
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Joshua Z Goldenberg, ND
• Email: jgoldenberg@nunm.edu
• Phone: 503-552-1555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.