A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health

NCT ID: NCT05876845

Last Updated: 2023-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2023-03-29

Brief Summary

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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.

Detailed Description

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Conditions

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Gut Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Group

Group Type EXPERIMENTAL

Combined pre-, pro-, and post-biotic supplement

Intervention Type OTHER

Participants will take 2 capsules daily with water, with their first meal of the day.

Interventions

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Combined pre-, pro-, and post-biotic supplement

Participants will take 2 capsules daily with water, with their first meal of the day.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beekeeper's Naturals Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20291

Identifier Type: -

Identifier Source: org_study_id

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