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Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth

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Conditions

Small Intestinal Bacterial Overgrowth Syndrome (SIBO)randomized controlled trialplaceboartemisia annuaSIBOsmall intestinal bacterial overgrowth

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth: A Phase I/II Triple-Masked, Placebo-Controlled Trial

Quick Facts

Study Start:2025-01-01
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06721884

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 18 years of age or older
  2. * IBS-SSS score \>175
  3. * Meets North American Consensus criteria for H2 SIBO
  4. * Willing to take Artecinua™ or placebo as a dietary supplement for 5 weeks
  5. * Willing to have two lactulose breath tests and do the prep diet 24 hours before and fast overnight before the test
  6. * Willing to have three blood drawstests and fast overnight before the draw
  7. * Able to speak, read, and understand English
  8. * Able to provide informed consent
  9. * 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
  1. * Use of antibiotic pharmaceuticals or supplements 14 days before baseline breath test
  2. * Initiation of change in diet, medication, or supplement regime within 30 days
  3. * Hospitalization within the past 3 months
  4. * Women who are breastfeeding, pregnant, or planning pregnancy in the next 4 months
  5. * Allergies to any of the ingredients in the study products.
  6. * 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
  7. * 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).
  8. * Drugs requiring activation for efficacy: Clopidogrel (CYP2C19), Codeine (CYP2D6), and Tamoxifen (CYP2D6) (citations).
  9. * GFR: \<30 mL/min/1.73m²
  10. * Hepatitis from any cause.
  11. * Excessive alcohol use (\> seven drinks/week in women and \> fourteen in men).
  12. * Hepatic (ALT, AST, bilirubin) and renal (creatinine, estimated GFR) parameters outside of normal range at screening.

Contacts and Locations

Study Contact

Joshua Z Goldenberg, ND
CONTACT
503-552-1555
jgoldenberg@nunm.edu

Study Locations (Sites)

Helfgott Research Institute - National University of Natural Medicine
Portland, Oregon, 97201
United States

Collaborators and Investigators

Sponsor: National University of Natural Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2026-01

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Small Intestinal Bacterial Overgrowth Syndrome (SIBO)