Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth

Phase

1/2

Condition

N/A

Treatment

Artemisia Annua Leaf

placebo

Clinical Study ID

NCT06721884

RB71024

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andfast 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 ortwo other concurrent forms of birth control to prevent pregnancy while enrolled

Exclusion

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/orother rare disorders that at the discretion of the PI or Clinical *Investigator mayimpact their safety or confound trial results
The use of any high-risk medications with narrow therapeutic indices metabolized byCYP450 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) parametersoutside of normal range at screening.

Study Design

Artemisia Annua Leaf

1/2

January 01, 2025

January 31, 2026

Study Description

Background: Small intestinal bacterial overgrowth (SIBO) often leads to bloating, abdominal pain, and stool change, and has significant impacts on quality of life. There is a high prevalence of SIBO among irritable bowel syndrome patients in particular and a growing awareness in the medical community of the impact of this condition. Anecdotal reports indicate that Artemisia annua, traditionally used against malaria, has shown promise in individuals with SIBO and previous studies suggest it has antimicrobials effects against E. coli and Kelbsiella, the bacteria associated with the hydrogen subtype of SIBO. This protocol describes the design of a phase II triple blind placebo controlled trial aiming to evaluate the safety and tolerability of 5g a day of dried leaf Artemisia annua in treating adults with hydrogen subtype SIBO over a 5 week period. Secondary objectives include the impact on symptom severity and exploratory outcomes include hydrogen and methane gas response.

Methods: A triple-blind, placebo-controlled, parallel-arm trial will enroll up to 32 participants from the Portland Oregon metropolitan area. Participants will undergo two lactulose breath tests, biweekly blood tests, and regular symptom assessments. Randomization will be computer-generated, stratified by symptom severity, with adherence closely monitored. Outcomes will measure changes in laboratory toxicology indicators, vital statistics, adverse events, and symptom severity. Data will be analyzed using appropriate statistical tests with a significance level set at p<.05.

Discussion: This is a protocol for a phase II trial of Artemisia annua in individuals with hydrogen subtype SIBO. This study helps address the dearth of formal studies of herbal treatments for SIBO and the results could provide a basis for larger trials and contribute to broader treatment strategies for this condition.

Connect with a study center

Helfgott Research Institute - National University of Natural Medicine
Portland, Oregon 97201
United States
Active - Recruiting

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