Clinical trial NCT04867512: Botanical Blend on the Gut Microbiome and Gut-Skin-Axis in Small Intestinal Bacterial Overgrowth (SIBO)
Official title: The Effects of a Botanical Blend on the Gut Microbiome and Gut-Skin-Axis in Small Intestinal Bacterial Overgrowth (SIBO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Intestinal Bacterial Overgrowth (SIBO)
Keywords: Small Intestinal Bacterial Overgrowth (SIBO)
gut health
microbiome
skin
dermatology
botanical medicine
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Biocidin
First posted: 2021-04-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label Prospective Study
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactulose Breath Test
timeFrame: 10 weeks
measure: Lactulose Breath Test
timeFrame: 14 weeks
Secondary outcomes:
measure: Gut Microbiome Changes
timeFrame: 10 weeks
measure: Gut Microbiome Changes
timeFrame: 14 weeks
Other outcomes:
measure: Safety Assessment for GI Distress
timeFrame: 10 weeks
measure: Safety Assessment for GI Distress
timeFrame: 14 weeks
measure: Facial Assessment for Redness
timeFrame: 10 weeks
measure: Facial Assessment for Redness
timeFrame: 14 weeks
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: