Artemisia Annua for Small Intestinal Bacterial Overgrowth

(HERBA-SIBO Trial)

Overseen By Joshua Z Goldenberg, ND

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National University of Natural Medicine

Must not be taking: Antibiotics, High-risk medications

Disqualifiers: Pregnancy, Chronic kidney/liver disease, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Artemisia annua, a plant, is safe and effective in treating small intestinal bacterial overgrowth (SIBO). SIBO often leads to bloating, stomach pain, and changes in bowel movements, impacting daily life. Participants will take either Artemisia annua or a placebo for five weeks, while researchers track symptom changes using questionnaires and tests. The trial seeks individuals with hydrogen-type SIBO who have been diagnosed with irritable bowel syndrome (IBS) and frequently experience digestive discomfort. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that Artemisia annua is likely to be safe for humans?

Research has shown that Artemisia annua might help combat bacteria linked to small intestinal bacterial overgrowth (SIBO), including E. coli and Klebsiella, which are associated with hydrogen-producing SIBO. Studies suggest that Artemisia annua can help balance gut bacteria, promoting a healthier gut.

Although specific safety data for SIBO is limited, Artemisia annua is currently being tested in early trials. While promising evidence exists, further research is necessary to fully understand its safety and tolerability.

Artemisia annua is already used in other areas, providing some indirect evidence of its safety. However, until more studies are completed, caution is advised, and staying updated on new findings is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for SIBO?

Unlike the standard treatments for Small Intestinal Bacterial Overgrowth (SIBO), which often involve antibiotics like rifaximin or herbal antimicrobials, Artemisia Annua offers a unique approach with its plant-based origin. Researchers are excited about Artemisia Annua because it contains compounds that may have antimicrobial properties, potentially providing a natural alternative to traditional antibiotics. This treatment could offer benefits with fewer side effects, making it an appealing option for those who prefer herbal remedies or have concerns about antibiotic resistance.

What evidence suggests that Artemisia annua might be an effective treatment for SIBO?

Research has shown that Artemisia annua, which participants in this trial may receive, might help manage small intestinal bacterial overgrowth (SIBO). Studies have found that it can fight bacteria like *E. coli* and *Klebsiella*, linked to a type of SIBO that produces hydrogen gas. Early reports suggest it might help reduce symptoms such as bloating and stomach pain. In some cases, plant-based treatments have effectively addressed SIBO and related conditions. While more research is needed, these findings are promising for those considering Artemisia annua as a treatment option. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

IBS-SSS score >175

Willing to have two lactulose breath tests and do the prep diet 24 hours before and fast overnight before the test

Exclusion Criteria

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

My kidney function is low.

Allergies to any of the ingredients in the study products

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: artemisia annua Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 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.

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06721884

Herbal Evaluation Of Artemisia Annua For Small Intestinal ... 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 ...

2. trialx.com trialx.com/clinical-trials/listings/319297/herbal-evaluation-of-artemisia-annua-for-small-intestinal-bacterial-overgrowth/

Herbal Evaluation Of Artemisia Annua For Small Intestinal ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11435404/

An Oral Botanical Supplement Improves Small Intestinal ... An oral botanical supplement improves small intestinal bacterial overgrowth (SIBO) and facial redness: results of an open-label clinical study.

4. ndnr.com ndnr.com/gastrointestinal/sibo-in-a-young-woman-a-cure-with-botanical-medicine/

SIBO in a Young Woman: A Cure with Botanical Medicine - This case highlights the overlap between SIBO and IBS, the importance of considering infectious origins, and the efficacy of botanical medicine ...

5. researchgate.net researchgate.net/publication/326133741_Herbs_for_Upper_Digestive_Overgrowth_of_Flora

(PDF) Herbs for Upper Digestive Overgrowth of Flora Here, the use of herbs with various types of effects on gut motility are reviewed, along with their known antimicrobial effects relevant to UDOF.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0032579124001731

Effects of dietary Artemisia annua supplementation on ... These findings suggest that Artemisia annua supplementation can significantly increase the abundance, diversity, and homogeneity of the intestinal microbiota.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11747653/

Effects of fermented Artemisia annua on the intestinal ... This study aimed to evaluate the protective and growth-promoting effects of fermented Artemisia annua (FA) on coccidian infection lambs, as well as analyze the ...

8. frontiersin.org frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2024.1390815/full

Artemisia annua L. polysaccharide improves the growth ... The aim of this study was to investigate the effects of dietary supplementation with Artemisia annua L. polysaccharide (AAP) on the growth performance and ...