32 Participants Needed

Artemisia Annua for Small Intestinal Bacterial Overgrowth

(HERBA-SIBO Trial)

JZ
Overseen ByJoshua Z Goldenberg, ND
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: National University of Natural Medicine

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not use antibiotics or start any new medications or supplements within 30 days before the study begins. Additionally, you cannot use certain high-risk medications or drugs that need activation to work. If you're on these, you may need to stop them before joining the trial.

What data supports the effectiveness of the treatment Artemisia Annua for small intestinal bacterial overgrowth?

Research indicates that herbal therapies, which may include treatments like Artemisia Annua, can be as effective as the antibiotic rifaximin for treating small intestinal bacterial overgrowth, offering an alternative for those interested in complementary therapies.12345

Is Artemisia annua safe for human use?

There have been reports of liver problems (hepatotoxicity) in people using Artemisia annua extract in grapeseed oil, with some needing hospital care. However, in a study for malaria treatment, traditional tea preparations of Artemisia annua were used without major safety concerns, though they were less effective than standard treatments.678910

How does the treatment Artemisia Annua differ from other treatments for small intestinal bacterial overgrowth?

Artemisia Annua is unique because it is a natural herb with antibacterial properties, which may help reduce harmful bacteria in the gut. Unlike standard antibiotics, it also has anti-inflammatory and antioxidant effects, potentially offering a broader range of benefits for gut health.68101112

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.

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
See 5 more

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
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 grams of dried Artemisia annua leaves or placebo daily for 5 weeks

5 weeks
Biweekly blood tests, regular symptom assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Artemisia Annua
Trial Overview 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.
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National University of Natural Medicine

Lead Sponsor

Trials
34
Recruited
1,400+

atelier temenos

Collaborator

Trials
1
Recruited
30+

References

Rifaximin dose-finding study for the treatment of small intestinal bacterial overgrowth. [2018]
Unravelling the controversy with small intestinal bacterial overgrowth. [2023]
The effectiveness of rotating versus single course antibiotics for small intestinal bacterial overgrowth. [2022]
Herbal therapy is equivalent to rifaximin for the treatment of small intestinal bacterial overgrowth. [2022]
5.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Microecological aspects of small intestinal bacterial overgrowth syndrome]. [2022]
Feeding Artemisia annua alters digesta pH and muscle lipid oxidation products in broiler chickens. [2020]
A Complementary Herbal Product for Controlling Giardiasis. [2021]
Randomized controlled trial of a traditional preparation of Artemisia annua L. (Annual Wormwood) in the treatment of malaria. [2013]
Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand. [2020]
Traditional application and modern pharmacological research of Artemisia annua L. [2021]
Effects of Artemisia annua L. Water Extract on Growth Performance and Intestinal Related Indicators in Broilers. [2023]
The potential of Artemisia annua L. as a locally produced remedy for malaria in the tropics: agricultural, chemical and clinical aspects. [2019]
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