Actively Recruiting
Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth: A Phase I/II Triple-Masked, Placebo-Controlled Trial
Led by National University of Natural Medicine · Updated on 2025-06-04
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National University of Natural Medicine
Lead Sponsor
A
atelier temenos
Collaborating Sponsor
AI-Summary
What this Trial Is About
Small intestinal bacterial overgrowth (SIBO) causes symptoms like bloating, stomach pain, and changes in bowel movements, affecting quality of life. This condition is common among people with irritable bowel syndrome (IBS). Researchers are studying Artemisia annua, a herb known for its antimicrobial effects against bacteria linked to hydrogen-type SIBO, to evaluate its safety and tolerability in adults with this condition. Participants will take either 5 grams of dried Artemisia annua leaves or a placebo daily for five weeks. The dosing starts with a gradual increase during the first week, reaching full dosage by the second week, and continues for four weeks. The placebo used is dried-leaf alfalfa, matched in weight and appearance to the Artemisia capsules. The study is triple-masked, meaning participants, researchers, and administrators do not know who receives the herb or placebo. During the study, participants will undergo two lactulose breath tests, biweekly blood tests, and regular symptom assessments through questionnaires. Researchers will monitor safety through blood tests, vital signs like heart rate and blood pressure, and any adverse events. Outcomes measured include quality of life, symptom severity, and gas response. The study includes up to 32 adults from the Portland, Oregon area and uses random assignment to treatment groups with close adherence monitoring.
CONDITIONS
Brief Title
Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- IBS-SSS score greater than 175
- Meets North American Consensus criteria for hydrogen subtype SIBO
- Willing to take Artemisia annua or placebo as a dietary supplement for 5 weeks
- Willing to have two lactulose breath tests with required diet prep and fasting
- Willing to have three blood draws with fasting before each
- Able to speak, read, and understand English
- Able to provide informed consent
- For people who can become pregnant, willing to use an intrauterine device or two other birth control methods during the study
You will not qualify if you...
- Use of antibiotics or supplements within 14 days before baseline breath test
- Changes in diet, medication, or supplements within 30 days before the study
- Hospitalization within the past 3 months
- Women who are breastfeeding, pregnant, or planning pregnancy in the next 4 months
- Allergies to any ingredients in the study products
- Chronic kidney or liver disease, cancer, colorectal disease, or other rare disorders that may affect safety or results
- Use of high-risk medications metabolized by CYP450 enzymes such as Warfarin, Tacrolimus, Cyclosporine, Efavirenz, and Codeine
- Use of drugs requiring activation for efficacy like Clopidogrel, Codeine, and Tamoxifen
- Glomerular filtration rate below 30 mL/min/1.73m2
- Hepatitis of any cause
- Excessive alcohol use (more than seven drinks per week for women or fourteen for men)
- Abnormal liver or kidney test results at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 weeks
Participants take either Artemisia annua dried leaf capsules or a placebo daily, gradually increasing to a full 5 gram dose, for a total of 5 weeks. Participants undergo symptom assessments, two lactulose breath tests, and biweekly blood tests during this period.
Weekly visits for assessments including two lactulose breath tests and biweekly blood draws
Trial Site Locations
Total: 1 location
1
Helfgott Research Institute - National University of Natural Medicine
Portland, Oregon, United States, 97201
Actively Recruiting
Research Team
J
Joshua Z Goldenberg, ND
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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