💬In plain words
What the trial is, and whether it could suit you
Small intestinal bacterial overgrowth (SIBO) can cause symptoms like bloating, stomach pain, and changes in bowel movements, significantly affecting quality of life. Many people with irritable bowel syndrome (IBS) also have SIBO, and there is growing recognition of how important it is to address this condition. Artemisia annua has shown potential in managing SIBO based on early reports and studies suggesting it can fight bacteria like \*E. coli\* and \*Klebsiella\*, which are linked to a type of SIBO that produces hydrogen gas.
This study aims to test if Artemisia annua is safe and well-tolerated for adults with hydrogen-type SIBO. Over five weeks, participants will take either 5 grams of dried Artemisia annua leaves or a placebo. Researchers will monitor safety through blood tests, vital signs, and adverse events, and they will assess symptom changes using questionnaires and breath tes
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Artemisia Annua Leaf
- placebo
Helfgott Research Institute - National University of Natural Medicine
Portland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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