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

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.

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Key information

Conditions

Gut Health

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Beekeeper's Naturals Inc

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: May 26, 2023
Registry last updated: May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed