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

April 29, 2021 updated by: Raja Sivamani, Integrative Skin Science and Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • Recruiting
        • Integrative Skin Science and Research
        • Principal Investigator:
          • Raja K Sivamani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Dietary supplement: 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.
Dietary supplement: GI Detox
GI Detox: 2 capsules by mouth every evening and 1 hour away from all food maintained through the duration of the study.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lactulose Breath Test
Time Frame: 10 weeks
Presence of SIBO
10 weeks
Lactulose Breath Test
Time Frame: 14 weeks
Presence of SIBO
14 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gut Microbiome Changes
Time Frame: 10 weeks
Alpha diversity
10 weeks
Gut Microbiome Changes
Time Frame: 14 weeks
Alpha diversity
14 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Assessment for GI Distress
Time Frame: 10 weeks
Survey based assessment
10 weeks
Safety Assessment for GI Distress
Time Frame: 14 weeks
Survey based assessment
14 weeks
Facial Assessment for Redness
Time Frame: 10 weeks
Via high resolution photography
10 weeks
Facial Assessment for Redness
Time Frame: 14 weeks
Via high resolution photography
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Integrative Skin Science and Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biocidin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIOSIBO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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