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.
Background: Small intestinal bacterial overgrowth (SIBO) often leads to bloating, abdominal pain, and stool change, and has significant impacts on quality of life. There is a high prevalence of SIBO among irritable bowel syndrome patients in particular and a growing awareness in the medical community of the impact of this condition. Anecdotal reports indicate that Artemisia annua, traditionally used against malaria, has shown promise in individuals with SIBO and previous studies suggest it has antimicrobials effects against E. coli and Kelbsiella, the bacteria associated with the hydrogen subtype of SIBO. This protocol describes the design of a phase II triple blind placebo controlled trial aiming to evaluate the safety and tolerability of 5g a day of dried leaf Artemisia annua in treating adults with hydrogen subtype SIBO over a 5 week period. Secondary objectives include the impact on symptom severity and exploratory outcomes include hydrogen and methane gas response. Methods: A triple-blind, placebo-controlled, parallel-arm trial will enroll up to 32 participants from the Portland Oregon metropolitan area. Participants will undergo two lactulose breath tests, biweekly blood tests, and regular symptom assessments. Randomization will be computer-generated, stratified by symptom severity, with adherence closely monitored. Outcomes will measure changes in laboratory toxicology indicators, vital statistics, adverse events, and symptom severity. Data will be analyzed using appropriate statistical tests with a significance level set at p\<.05. Discussion: This is a protocol for a phase II trial of Artemisia annua in individuals with hydrogen subtype SIBO. This study helps address the dearth of formal studies of herbal treatments for SIBO and the results could provide a basis for larger trials and contribute to broader treatment strategies for this condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
32
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
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.
Helfgott Research Institute - National University of Natural Medicine
Portland, Oregon, United States
RECRUITINGComplete 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
Vital sign measurement (temperature)
degrees F
Time frame: 5 weeks
Vital sign measurement (weight)
kg
Time frame: 5 weeks
Vital sign measurement (height)
meters
Time frame: 5 weeks
Vital sign measurement (body mass index)
weight (kg) / \[height (m)\]²
Time frame: 5 weeks
Adverse event monitoring
Adverse events
Time frame: 5 weeks
Quality of life
IBS-QoL
Time frame: 5 weeks
Symptom severity
GI symptom severity (IBS-SSS)
Time frame: 5 weeks
Adequate relief
IBS-AR
Time frame: 5 weeks
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