Botanical Blend on the Gut Microbiome and Gut-Skin-Axis in Small Intestinal Bacterial Overgrowth (SIBO)

Study Overview
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Brief Summary
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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.

Detailed Description
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Certain oral botanical blends have many antimicrobial properties. This study will evaluate if a botanical blend can improve the gut and skin health of people with small intestinal bacterial overgrowth (SIBO) since it is caused by an overgrowth of bacteria in the small intestine.

Official Title
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The Effects of a Botanical Blend on the Gut Microbiome and Gut-Skin-Axis in Small Intestinal Bacterial Overgrowth (SIBO)

Conditions
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Small Intestinal Bacterial Overgrowth (SIBO)

Intervention / Treatment
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* Dietary Supplement: Liquid Tincture
* Dietary Supplement: GI Detox
* Dietary Supplement: Olivirex


Participation Criteria
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Eligibility Criteria
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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 been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating, or post-menopausal. Is participating in a concurrent clinical research study or has participated in an acne or other facial study at this or any other facility in the past 4 weeks. Those with BMI higher than 35 kg/m². Commencement of a new diet (such as the ketogenic diet) or supplements within the 1 month prior to initiating participation, at the discretion of the investigator. Use of medications that alter blood lipids, such as statins and anti- hyperlipidemic medications. Is participating in or has participated in a facial study at this or any other facility in the past 4 weeks. Participation in survey-based studies is approved at the discretion of the investigator. Has a skin disease on face that will interfere with image collection and assessment in the opinion of the investigator. Refusal to shave or remove facial hair that may interfere with image collection and assessment. Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, sun tanning, or artificial tanning. Known allergy or irritation to the facial products utilized in the study. Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco. Prisoners Any persons with current or a history of alcohol abuse Adults unable to consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-Label Prospective Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants will be taking one liquid tincture orally per day as well as 2 capsules orally at night. At week 10, non-responders will take another supplement consisting of 2 capsules orally along with the liquid tincture until week 14. | Dietary Supplement: Liquid Tincture<br>* Biocidin Liquid Tincture: 1 drop by mouth twice daily, increased by one drop each day until 15 drops twice daily have been reached. 15 drops by mouth twice daily will be maintained through the duration of the study.<br>Dietary Supplement: GI Detox<br>* GI Detox: 2 capsules by mouth every evening and 1 hour away from all food maintained through the duration of the study.<br>Dietary Supplement: Olivirex<br>* Olivirex: 2 capsules by mouth twice daily taken with Biocidin liquid tincture starting at week 10 until week 14 of the study for non-responders determined by symptoms and lactulose breath test results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactulose Breath Test | Presence of SIBO | 10 weeks | 
| Lactulose Breath Test | Presence of SIBO | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut Microbiome Changes | Alpha diversity | 10 weeks | 
| Gut Microbiome Changes | Alpha diversity | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small Intestinal Bacterial Overgrowth (SIBO), gut health, microbiome, skin, dermatology, botanical medicine