Artemisia Annua for Small Intestinal Bacterial Overgrowth
(HERBA-SIBO Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National University of Natural Medicine

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Adults with hydrogen-type Small Intestinal Bacterial Overgrowth (SIBO) in the Portland, Oregon area can join this trial. It's for those who experience symptoms like bloating and stomach pain. Participants must be willing to take either an herb or a placebo without knowing which one they receive.

Inclusion Criteria

Meets North American Consensus criteria for H2 SIBO

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 draw tests and fast overnight before the draw

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Exclusion Criteria

My kidney function is low.

Excessive alcohol use (> seven drinks/week in women and > fourteen in men)

Allergies to any of the ingredients in the study products

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Treatment Details

Interventions

Artemisia Annua (Herbal Medicine)

Trial OverviewThe trial is testing Artemisia annua leaves against a placebo to see if it helps with SIBO symptoms. Each participant will get either 5 grams of the herb or a fake pill for five weeks, and researchers will track their health and symptom changes.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: artemisia annuaExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

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.