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

Gut Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05876845
• Other study ID #: 20291
• Status: Completed
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: March 29, 2023

Study information

• Verified date: May 2023
• Source: Beekeeper's Naturals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gut Health

Intervention

Other:
• Combined pre-, pro-, and post-biotic supplement
Participants will take 2 capsules daily with water, with their first meal of the day.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Beekeeper's Naturals Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	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.	4 weeks