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New treatment option for Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
Official title Herbal Evaluation Of Artemisia Annua For Small Intestinal Bacterial Overgrowth
ClinicalTrials.gov ID: NCT06721884
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
See the full eligibility criteria
- 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
- 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 how well it works: 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.
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.