Gut HealthNCT05876845
A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health
A study testing Combined pre-, pro-, and post-biotic supplement in people with Gut Health, run by Beekeeper's Naturals Inc at 1 site in United States.
Trial summary
This is a virtual, single-arm clinical trial that will last 4-weeks. Participants will take the supplement daily and complete questionnaires at baseline, week 2, and week 4. Participants will provide photos of their face and stomach at baseline and week 4. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Health
- What is being tested?
- Combined pre-, pro-, and post-biotic supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 29 Mar 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women
- 18 years of age or older
- Experience at least one of the following symptoms: regular bloating/gas, irregular bowel movements, heartburn, or poor digestive health
- Generally healthy
Who cannot join
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Allergic to bees, bee products, poplar tree products, or balsam of Peru
- Anyone with known severe allergic reactions.
- Women who are pregnant, breastfeeding or attempting to become pregnant
- Unwilling to follow the study protocol.
- Has introduced any new forms of medication or supplements targeting gut health within the last 3 months
- Has taken antibiotics in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual, single-arm clinical trial that will last 4-weeks. Participants will take the supplement daily and complete questionnaires at baseline, week 2, and week 4. Participants will provide photos of their face and stomach at baseline and week 4.
Gut health and associated health outcomes, including brain, skin, and immune function, will be evaluated at baseline and at each check-in. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Baseline and endline photos from each study part will be provided by participants.
- Conditions
- Gut Health
- Being tested
- Combined pre-, pro-, and post-biotic supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined pre-, pro-, and post-biotic supplementOther
Participants will take 2 capsules daily with water, with their first meal of the day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: Combined pre-, pro-, and post-biotic supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant-reported gastrointestinal symptoms [Time Frame: Baseline to 4 weeks]
Assessed via study-specific questionnaires to gather information on improvements in bloating, digestion, stool regularity, stool quality, and gas. Survey-based assessments (0-5, 0-6 point scale) of changes in bloating, digestion, stool regularity, stool quality, and gas.
Measured: 4 weeks
Change in scores on the Gastrointestinal Symptom Rating Scale (GSRS) [Time Frame: Baseline to 4
Use of validated questionnaire the GSRS to assess gastrointestinal symptoms.The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters reporting on Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents no symptoms and 7 represents severe symptoms.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start9 Feb 2023
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beekeeper's Naturals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876845
- Sponsor's protocol ID
- 20291
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health
- ClinicalTrials.gov ID
- NCT05876845
- Acronym / sponsor ID
- 20291
- Conditions
- Gut Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Beekeeper's Naturals IncIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 26 May 2023 (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.
This is a virtual, single-arm clinical trial that will last 4-weeks. Participants will take the supplement daily and complete questionnaires at baseline, week 2, and week 4. Participants will provide photos of their face and stomach at baseline and week 4.
Gut health and associated health outcomes, including brain, skin, and immune function, will be evaluated at baseline and at each check-in. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Baseline and endline photos from each study part will be provided by participants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Combined pre-, pro-, and post-biotic supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women
- 18 years of age or older
- Experience at least one of the following symptoms: regular bloating/gas, irregular bowel movements, heartburn, or poor digestive health
- Generally healthy
Key exclusion criteria (7 listed)
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Allergic to bees, bee products, poplar tree products, or balsam of Peru
- Anyone with known severe allergic reactions.
- Women who are pregnant, breastfeeding or attempting to become pregnant
- Unwilling to follow the study protocol.
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 |
|---|---|---|
| Combined pre-, pro-, and post-biotic supplementParticipants will take 2 capsules daily with water, with their first meal of the day. | Other | Intervention Group |
Primary outcome
Change in participant-reported gastrointestinal symptoms [Time Frame: Baseline to 4 weeks]
Time frame: 4 weeks
Assessed via study-specific questionnaires to gather information on improvements in bloating, digestion, stool regularity, stool quality, and gas. Survey-based assessments (0-5, 0-6 point scale) of changes in bloating, digestion, stool regularity, stool quality, and gas.
Change in scores on the Gastrointestinal Symptom Rating Scale (GSRS) [Time Frame: Baseline to 4
Time frame: 4 weeks
Use of validated questionnaire the GSRS to assess gastrointestinal symptoms.The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters reporting on Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents no symptoms and 7 represents severe symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined pre-, pro-, and post-biotic supplement in people with Gut Health, run by Beekeeper's Naturals Inc 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 26 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant-reported gastrointestinal symptoms [Time Frame: Baseline to 4 weeks] (time frame: 4 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 26 May 2023.