Recruiting
Phase 1
Phase 2

Artemisia Annua

Sponsor:

National University of Natural Medicine

Code:

NCT06721884

Conditions

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Artemisia Annua Leaf

placebo

Study Details

Brief summary:

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 tests.

The trial will include up to 32 participants from the Portland, Oregon area. Participants will be randomly assigned to treatment groups, and neither they, the researchers, nor the test administrators will know who is receiving the herb or the placebo. Results will be analyzed using standard statistical methods.

This study addresses the lack of research on herbal treatments for SIBO. If successful, the findings could lead to larger studies and help expand treatment options for people with SIBO.

Conditions

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

Study ID

NCT06721884

Start date

Jan 1, 2025

Status verified date

May, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: artemisia annua

placebo comparator: Placebo

We have chosen dried-leaf alfalfa of equal weight and dosing to the interventional product (5 grams, 15 caps, 5/am, 5/noon, 5/pm for the 4 weeks of the intervention period plus an additional 1 week dose escalation period to match the dosing of the Artemisia product). We have chosen this as a comparator in consultation with SIBO and herbal medicine content experts as alfalfa matches the texture and color of Artemisia annua and, in the doses used, will provide no meaningful amounts of FODMAPs or antimicrobial phytochemicals. The alfalfa will be sourced from Bulk Apotherapy, LCC, and encapsulated at the same facility as the Artemisia capsules. Containers of placebo capsules will be kept in a secured cabinet before being administered, under climate-controlled conditions, and checked weekly to ensure consistent ambient temperature.

Interventions

Artemisia Annua Leaf

The intervention is Artecinua™ which is an organic Artemisia annua dried leaf powder in a vegan / kosher/ halal capsule. Artemisia annua L is classified as a 'generally regarded as safe' (GRAS) herb. Participants will be instructed to wean up to a full 5g dose by the following schedule.

1. gram (3 caps) 1st day,
2. grams (6 caps) 3/am, 3/pm, for the 3rd day,
3. grams (9 caps) 3/am 3/noon 3/pm for the 5th day,
4. grams (12 caps) 4/am, 4/noon, 4/pm for the 7th day,
5. grams (15 caps) 5/am, 5/noon, 5/pm for rest of intervention period (4 weeks)

Containers of ArtecinuaTM will be kept in a secured cabinet before being administered, under climate-controlled conditions, and checked weekly to ensure consistent ambient temperature.

The justification of the 5g a day dosing is based on empiric experience and is in line with recommended dosages by the pharmacopeia of the People's Republic of China and has been previously used in clinical trials

placebo

We have chosen dried-leaf alfalfa of equal weight and dosing to the interventional product (5 grams, 15 caps, 5/am, 5/noon, 5/pm for the 4 weeks of the intervention period plus an additional 1 week dose escalation period to match the dosing of the Artemisia product). We have chosen this as a comparator in consultation with SIBO and herbal medicine content experts as alfalfa matches the texture and color of Artemisia annua and, in the doses used, will provide no meaningful amounts of FODMAPs or antimicrobial phytochemicals. The alfalfa will be sourced from Bulk Apotherapy, LCC, and encapsulated at the same facility as the Artemisia capsules. Containers of placebo capsules will be kept in a secured cabinet before being administered, under climate-controlled conditions, and checked weekly to ensure consistent ambient temperature.

Primary outcome measure

  • Complete blood count [ Time Frame: 5 weeks ]
  • Comprehensive metabolic profile [ Time Frame: 5 weeks ]
  • Vital sign measurement (heart rate) [ Time Frame: 5 weeks ]
  • Vital sign measurement (blood pressure) [ Time Frame: 5 weeks ]
  • Vital sign measurement (temperature) [ Time Frame: 5 weeks ]
  • Vital sign measurement (weight) [ Time Frame: 5 weeks ]
  • Vital sign measurement (height) [ Time Frame: 5 weeks ]
  • Vital sign measurement (body mass index) [ Time Frame: 5 weeks ]
  • Adverse event monitoring [ Time Frame: 5 weeks ]
  • Quality of life [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Joshua Z Goldenberg, ND

503-552-1555jgoldenberg@nunm.edu

Locations

Helfgott Research Institute - National University of Natural Medicine

Recruiting

Portland, Oregon, United States, 97201

Contacts

Administrator

503-552-1555cjackson@nunm.edu

More Information

Sponsor

National University of Natural Medicine

Last update posted

Jun 4, 2025

Last verified

May, 2025

Keywords

  • randomized controlled trial
  • placebo
  • artemisia annua
  • SIBO
  • small intestinal bacterial overgrowth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National University of Natural Medicine on 2025-06-04.