Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06721884

Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth

Led by National University of Natural Medicine · Updated on 2025-06-04

32

Participants Needed

1

Research Sites

52 weeks

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) 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

Official Title

Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 daily for 5 weeks
  • Willing to complete two lactulose breath tests with required preparation
  • Willing to have three blood draws and fast overnight before each
  • Able to speak, read, and understand English
  • Able to provide informed consent
  • Individuals of child-bearing potential must agree to use an intrauterine device or two other forms of birth control during the study
Not Eligible

You will not qualify if you...

  • Use of antibiotics or supplements in the 14 days before baseline breath test
  • Change in diet, medication, or supplement within 30 days before 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 serious disorders that may affect safety or results
  • Use of high-risk medications metabolized by CYP450 enzymes including Warfarin, Tacrolimus, Cyclosporine, Efavirenz, and Codeine
  • Use of drugs requiring activation for efficacy such as Clopidogrel, Codeine, and Tamoxifen
  • Glomerular filtration rate less than 30 mL/min/1.73m2
  • Hepatitis of any cause
  • Excessive alcohol use (more than 7 drinks/week for women, more than 14 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

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Trial Site Locations

Total: 1 location

1

Helfgott Research Institute - National University of Natural Medicine

Portland, Oregon, United States, 97201

Actively Recruiting

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Research Team

J

Joshua Z Goldenberg, ND

CONTACT

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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