Small Intestinal Bacterial Overgrowth (SIBO)NCT04867512
Botanical Blend on the Gut Microbiome and Gut-Skin-Axis in Small Intestinal Bacterial Overgrowth (SIBO)
A study testing Liquid Tincture, GI Detox and Olivirex in people with Small Intestinal Bacterial Overgrowth (SIBO), run by Integrative Skin Science and Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Intestinal Bacterial Overgrowth (SIBO)
- What is being tested?
- Liquid Tincture, GI Detox and Olivirex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Skin Science and Research
Sacramento, California, 95816
Raja K Sivamani, MD, 916-524-1216, raja.sivamani@integrativeskinresearch.com
Raja K Sivamani, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Liquid Tincture, GI Detox, Olivirex
- Keywords
- Small Intestinal Bacterial Overgrowth (SIBO), gut health, microbiome, skin, dermatology, botanical medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid TinctureDietary supplement
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 DetoxDietary supplement
GI Detox: 2 capsules by mouth every evening and 1 hour away from all food maintained through the duration of the study.
OlivirexDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Dietary Supplement: Liquid Tincture; Dietary Supplement: GI Detox; Dietary Supplement: Olivirex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactulose Breath Test
Presence of SIBO
Measured: 10 weeks
Lactulose Breath Test
Presence of SIBO
Measured: 14 weeks
Secondary outcomes (2)
Gut Microbiome Changes
Alpha diversity
Measured: 10 weeks
Gut Microbiome Changes
Alpha diversity
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start27 Apr 2021 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Bacterial Overgrowth (SIBO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label Prospective Study
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biocidin
- Responsible party
- Principal investigator, Raja Sivamani, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867512
- Sponsor's protocol ID
- BIOSIBO1
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Botanical Blend on the Gut Microbiome and Gut-Skin-Axis in Small Intestinal Bacterial Overgrowth (SIBO)
- ClinicalTrials.gov ID
- NCT04867512
- Acronym / sponsor ID
- BIOSIBO1
- Keywords
- Small Intestinal Bacterial Overgrowth (SIBO), gut health, microbiome, skin, dermatology, botanical medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Biocidin
- Study start
- 27 Apr 2021 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label Prospective Study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Liquid Tincture, Dietary Supplement: GI Detox, Dietary Supplement: OlivirexParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid TinctureBiocidin 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 | Intervention Group |
| GI DetoxGI Detox: 2 capsules by mouth every evening and 1 hour away from all food maintained through the duration of the study. | Dietary supplement | Intervention Group |
| OlivirexOlivirex: 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. | Dietary supplement | Intervention Group |
Primary outcome
Lactulose Breath Test
Time frame: 10 weeks
Presence of SIBO
Lactulose Breath Test
Time frame: 14 weeks
Presence of SIBO
2 secondary outcomes
Gut Microbiome Changes
Time frame: 10 weeks
Gut Microbiome Changes
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Integrative Skin Science and Research
Sacramento, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Tincture, GI Detox and Olivirex in people with Small Intestinal Bacterial Overgrowth (SIBO), run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactulose Breath Test (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.