Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth

ConditionSmall Intestinal Bacterial Overgrowth Syndrome (SIBO)

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorNational University of Natural Medicine

About 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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Artemisia Annua Leaf
Dietary supplement
The intervention is Artecinua™ which is an organic Artemisia annua dried leaf powder in a vegan / kosher/ halal capsule. Artemisia annua L is classified as a 'generally regarded as safe' (GRAS) herb. Participants will be instructed to wean up to a full 5g dose by the following schedule. 1. gram (3 caps) 1st day, 2. grams (6 caps) 3/am, 3/pm, for the 3rd day, 3. grams (9 caps) 3/am 3/noon 3/pm for the 5th day, 4. grams (12 caps) 4/am, 4/noon, 4/pm for the 7th day, 5. grams (15 caps) 5/am, 5/noon, 5/pm for rest of intervention period (4 weeks) Containers of ArtecinuaTM will be kept in a secured cabinet before being administered, under climate-controlled conditions, and checked weekly to ensure consistent ambient temperature. The justification of the 5g a day dosing is based on empiric experience and is in line with recommended dosages by the pharmacopeia of the People's Republic of China and has been previously used in clinical trials
placebo
Other 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.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: artemisia annuaExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Complete blood count

RBC, WBC, platelets

Time frame

5 weeks

Comprehensive metabolic profile

eGFR, electrolytes, BUN:Cr, AST, ALT, GGT, alkaline phosphatase, bilirubin

Time frame

5 weeks

Vital sign measurement (heart rate)

bpm

Time frame

5 weeks

Vital sign measurement (blood pressure)

mmHg

Time frame

5 weeks

Secondary outcomes

Symptom severity

GI symptom severity (IBS-SSS)

Time frame

5 weeks

Adequate relief

IBS-AR

Time frame

5 weeks

Other outcomes

H2 gas response

H2 gas lactulose breath test. Day 0 to 35 difference measured by Δ baseline to 90 min in each test.

Time frame

5 weeks

CH4 gas response

CH4 gas lactulose breath test. Day 0 to 35 difference measured by peak CH4 in each test.

Time frame

5 weeks

Gas resolution

H2/CH4 lactulose breath test. Count of those with \<20 ppm rise from baseline to 90 min H2 and \<10 ppm absolute on CH4 by trial closeout.

Time frame

5 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Natural Medicine

Lead sponsor

atelier temenos

Collaborator

Source ClinicalTrials.gov

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