Artemisia annua for hydrogen-type small intestinal bacterial overgrowth (SIBO)
Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth: A Phase I/II Triple-Masked, Placebo-Controlled Trial
This trial will try 5 grams a day of dried Artemisia annua leaves or a placebo in adults with hydrogen-type SIBO to see if it is safe and helps symptoms.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National University of Natural Medicine Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06721884 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with hydrogen-type SIBO meeting North American Consensus criteria, an IBS-SSS score >175, willing to take the supplement or placebo for five weeks and attend breath tests and blood draws at the Portland study site.
Not a fit: People with methane-type SIBO, recent antibiotic use, current pregnancy or breastfeeding, known allergy to Artemisia ingredients, or those unwilling to follow the testing and visit schedule are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could offer a safe, plant-based oral option that reduces symptoms and bacterial overgrowth in people with hydrogen-type SIBO.
How similar studies have performed: Preclinical data and anecdotal reports suggest Artemisia annua has antimicrobial effects against organisms like E. coli and Klebsiella, but randomized controlled evidence for SIBO treatment is limited, making this a relatively novel, early-phase test.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Portland, Oregon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.