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Herbal Medicine

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

Phase 1 & 2

Waitlist Available

Research Sponsored by National University of Natural Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

GFR: <30 mL/min/1.73m²

Hospitalization within the past 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Summary

This trial aims to test if Artemisia annua, an herb, is safe and effective in managing Small Intestinal Bacterial Overgrowth (SIBO) symptoms in adults. Participants will take either

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects are not specified but will be monitored through blood tests, vital signs checks, and reports of any adverse events during the study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is low.

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I have been hospitalized in the last 3 months.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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My liver and kidney function tests are not within the normal range.

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I am not taking medications like Warfarin, Tacrolimus, Efavirenz, or Codeine.

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I have hepatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse event monitoring

Complete blood count

Comprehensive metabolic profile

+7 more

Secondary study objectives

Adequate relief

Symptom severity

Other study objectives

CH4 gas response

Gas resolution

H2 gas response

Trial Design

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.

0 / 6Eligibility criteria met