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New treatment option for Small Intestinal Bacterial Overgrowth
Official title Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®
ClinicalTrials.gov ID: NCT06298409
What this study is testing
- What it's testing
- We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Males or females 18 years of age or older and 80 years of age or younger at the time of the first Screening Visit.
- ASA Classification 1 or 2.
- For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit.
- Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine...
- Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and...
You likely can't join if
- History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet...
- Actively taking a proton-pump-inhibitor medication within 30 days of enrollment
- Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
- Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic...
- A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
See the full eligibility criteria
- Males or females 18 years of age or older and 80 years of age or younger at the time of the first Screening Visit.
- ASA Classification 1 or 2.
- For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit.
- Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
- Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.
- Positive for at least one clinical symptom consistent with SIBO.
- Positive lactulose breath test for SIBO, by Hydrogen (H2) criteria.
- Prescribed, but has not started, a two-week course of Rifaximin for SIBO.
- History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet obstruction, diverticulitis, inflammatory bowel disease, ileostomy or...
- Actively taking a proton-pump-inhibitor medication within 30 days of enrollment
- Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
- Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with...
- A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
The study team makes the final eligibility decision.
Where it's taking place
- Mountain View, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mountain View, California, 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.