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

May 15, 2023 updated by: Beekeeper's Naturals Inc

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • 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
      • Santa Monica, California, United States, 90404
        • Citruslabs

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Other: Combined pre-, pro-, and post-biotic supplement
Participants will take 2 capsules daily with water, with their first meal of the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks

Collaborators and Investigators

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

Sponsor

Beekeeper's Naturals Inc

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 (Actual)

February 9, 2023

Primary Completion (Actual)

March 29, 2023

Study Completion (Actual)

March 29, 2023

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20291 (Other Identifier: City of Hope Comprehensive Cancer Center)

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.

Clinical Trials on Gut Health

Clinical Trials on Combined pre-, pro-, and post-biotic supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe