Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth

NCT06721884 | Recruiting Phase 1

• 1 other identifier: RB71024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

Keywords

randomized controlled trial; placebo; artemisia annua; SIBO; small intestinal bacterial overgrowth

Outcome Measures

Primary Outcomes (10)

• Complete blood count

  RBC, WBC, platelets

  5 weeks

• Comprehensive metabolic profile

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

  5 weeks

• Vital sign measurement (heart rate)

  bpm

  5 weeks

• Vital sign measurement (blood pressure)

  mmHg

  5 weeks

• Vital sign measurement (temperature)

  degrees F

  5 weeks

• Vital sign measurement (weight)

  kg

  5 weeks

• Vital sign measurement (height)

  meters

  5 weeks

• Vital sign measurement (body mass index)

  weight (kg) / \[height (m)\]²

  5 weeks

• Adverse event monitoring

  Adverse events

  5 weeks

• Quality of life

  IBS-QoL

  5 weeks

Secondary Outcomes (2)

• Symptom severity

  5 weeks

• Adequate relief

  5 weeks

Other Outcomes (3)

• H2 gas response

  5 weeks

• CH4 gas response

  5 weeks

• Gas resolution

  5 weeks

Study Arms (2)

artemisia annua

EXPERIMENTAL

Dietary Supplement: Artemisia Annua Leaf

Placebo

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

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

artemisia annua

placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 drawstests and fast overnight before the draw
• Able to speak, read, and understand English
• Able to provide informed consent
• For individuals of child-bearing potential, willing to use an intrauterine device or two other concurrent forms of birth control to prevent pregnancy while enrolled

You may not qualify if:

• 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
• Allergies to any of the ingredients in the study products.
• Individuals with chronic kidney or liver disease, cancer, colorectal disease and/or other rare disorders that at the discretion of the PI or Clinical \*Investigator may impact their safety or confound trial results
• The use of any high-risk medications with narrow therapeutic indices metabolized by CYP450 enzymes: Warfarin (CYP2C9), Tacrolimus/Cyclosporine (CYP3A4), Efavirenz (CYP2B6), and Codeine (CYP2D6).
• Drugs requiring activation for efficacy: Clopidogrel (CYP2C19), Codeine (CYP2D6), and Tamoxifen (CYP2D6) (citations).
• GFR: \<30 mL/min/1.73m²
• Hepatitis from any cause.
• Excessive alcohol use (\> seven drinks/week in women and \> fourteen in men).
• Hepatic (ALT, AST, bilirubin) and renal (creatinine, estimated GFR) parameters outside of normal range at screening.

Sponsors & Collaborators

• National University of Natural Medicine: lead
• atelier temenos: collaborator

Study Sites (1)

Helfgott Research Institute - National University of Natural Medicine

Portland, Oregon, 97201, United States

RECRUITING

Central Study Contacts

Joshua Z Goldenberg, ND

CONTACT

503-552-1555; jgoldenberg@nunm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)