Botanical Blend on the Gut Microbiome and Gut-Skin-Axis in Small Intestinal Bacterial Overgrowth … (NCT04867512) | Clinical Trial Compass
UnknownNot Applicable
Botanical Blend on the Gut Microbiome and Gut-Skin-Axis in Small Intestinal Bacterial Overgrowth (SIBO)
United States35 participantsStarted 2021-04-27
Plain-language summary
The purpose of this study is to assess how an oral botanical blend alters the gut microbiome and the skin biophysical properties in people with SIBO.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Subjects between 18-60 years of age
* Must be willing to comply with all protocol requirements
* Must be willing to have flash photo facial images taken with the imaging systems
* Males must be willing to shave any facial hair
* Subjects with (Small Intestine Bacterial Overgrowth) SIBO
Exclusion Criteria:
* Any systemic or antibiotics (injected or oral) within 6 months of starting the study.
* Any topical antibiotic or benzoyl peroxide within 2 months of starting the study or any subject unwilling to refrain from washout of topical antibacterial or benzoyl peroxide ingredient.
* Any other topical products within 2 weeks of starting the study.
* Any oral probiotics or prebiotics within 3 months of starting the study.
* Any other oral supplements within 3 months of starting the study.
* Subjects must have no history of malignancy or cancer or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis, irritable bowel disease, multiple sclerosis, Parkinson's disease)
* Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results
* Has a condition where evening medication dosing is required
* Has any gastrointestinal motility condition
* Women who have b…