The Effects of a Postbiotic Supplement on Biomarkers of Gut Health

Part of paid clinical trials in Canfield, Ohio.

Sponsor
Verb Biotics LLC
Study ID
NCT07527286
Status
Completed

Conditions

  • Bloating
  • Butyrate
  • Cortisol
  • Gastrointestinal
  • Gastrointestinal Upset
  • Immuno-modulation
  • Microbiota
  • Microbiota Balance

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Postbiotic — DIETARY_SUPPLEMENT
    300mg

Study Details

This study is a randomized, double-blind, two-arm, placebo-controlled trial of N=80 (40/arm) apparently healthy men and women between 18 and 65 years old to be recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences). This study will assess the effectiveness of a postbiotic supplement on various biomarkers of health. Consumption of this dietary supplement is not intended to diagnose, treat, cure, or prevent any disease. Participants will attend three in-person study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet). Over the next 4 weeks, participants will attend two in-person visits: \[visit 2 (week 0) and visit 3 (week 4)\] wherein assessments of gut function \[fecal microbiome diversity, short chain fatty acids (SCFA), and fecal butyrate\], serum butyrate, serum zonulin, salivary cortisol, and Gastrointestinal Symptom Rating Scale (GSRS) for gastrointestinal (GI) health, emotional states \[Depression, Anxiety and Stress Scale (DASS21)\], and quality of life (SF-36 questionnaire) will be assessed. Participants will also be provided home kits with instructions on how to collect stool and saliva samples on two separate occasions (i.e., visit 2, visit 3) during the study. • Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure participant safety and scientific integrity of the data.

Key Dates

Start date
Nov 5, 2024
Status verified
Apr 2026
Primary completion
Apr 26, 2025
Completion
Apr 26, 2025

Study Design

Enrollment
76 participants (actual)

Arms

  • Arm: Placebo Group
    Participants who meet the study eligibility criteria will be randomly assigned to the study product or the placebo group. The study placebo will only contain maltodextrin.
  • Arm: Postbiotic Study Product
    Participants who meet the study eligibility criteria will be randomly assigned to the study product or the placebo group. The study product will contain Keystone postbiotic and maltodextrin.

Primary Outcome Measure

Evaluate the change in fecal microbiome diversity. [ Time Frame: Participants will complete up to 5-week study consisting from screening, randomization, and enrollment periods to the end of treatment at 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Center for Applied Health SciencesCanfieldOhio44406-

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By research site
The Center for Applied Health Sciences· Canfield, OH

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