Recruiting

Botanical Blend

Sponsor:

Integrative Skin Science and Research

Code:

NCT04867512

Conditions

Small Intestinal Bacterial Overgrowth (SIBO)

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Liquid Tincture

GI Detox

Olivirex

Study Details

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.

Conditions

Small Intestinal Bacterial Overgrowth (SIBO)

Study ID

NCT04867512

Start date

Apr 27, 2021

Status verified date

Apr, 2021

Completion date

Feb 1, 2022

Anticipated

Primary completion date

Apr 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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.

Interventions

Liquid Tincture

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.

GI Detox

GI Detox: 2 capsules by mouth every evening and 1 hour away from all food maintained through the duration of the study.

Olivirex

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.

Primary outcome measure

  • Lactulose Breath Test [ Time Frame: 10 weeks ]
  • Lactulose Breath Test [ Time Frame: 14 weeks ]

Central Contacts and Locations

Locations

Integrative Skin Science and Research

Recruiting

Sacramento, California, United States, 95816

Contacts

Raja K Sivamani, MD

916-524-1216raja.sivamani@integrativeskinresearch.com

Principal Investigator:

Raja K Sivamani, MD

More Information

Sponsor

Integrative Skin Science and Research

Last update posted

May 4, 2021

Last verified

Apr, 2021

Keywords

  • Small Intestinal Bacterial Overgrowth (SIBO)
  • gut health
  • microbiome
  • skin
  • dermatology
  • botanical medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Integrative Skin Science and Research on 2021-05-04.