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

Last updated: April 29, 2021
Sponsor: Integrative Skin Science and Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04867512
BIOSIBO1
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 orany subject unwilling to refrain from washout of topical antibacterial or benzoylperoxide 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 gastrointestinalinflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis ofimmunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus,rheumatoid arthritis, irritable bowel disease, multiple sclerosis, Parkinson'sdisease)
  • Has a condition or is on medication the investigator and/or designee believe couldjeopardize the safety of the subject, interfere with the evaluation, or confound theinterpretation 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 bepregnant or lactating, or post-menopausal.
  • Is participating in a concurrent clinical research study or has participated in anacne 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 1month prior to initiating participation, at the discretion of the investigator.
  • Use of medications that alter blood lipids, such as statins and anti- hyperlipidemicmedications.
  • Is participating in or has participated in a facial study at this or any otherfacility in the past 4 weeks. Participation in survey-based studies is approved at thediscretion of the investigator.
  • Has a skin disease on face that will interfere with image collection and assessment inthe opinion of the investigator.
  • Refusal to shave or remove facial hair that may interfere with image collection andassessment.
  • Persons unwilling to avoid the following during the 4 weeks prior and during theduration 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 5year-pack year history of smoking tobacco.
  • Prisoners
  • Any persons with current or a history of alcohol abuse
  • Adults unable to consent

Study Design

Total Participants: 35
Study Start date:
April 27, 2021
Estimated Completion Date:
February 01, 2022

Study 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.

Connect with a study center

  • Integrative Skin Science and Research

    Sacramento, California 95816
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.