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The Effects of a Postbiotic Supplement on Biomarkers of Gut Health

NCT07527286 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2026-04-14

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Postbiotic

300mg

Sponsors & Collaborators

  • Verb Biotics LLC

    lead INDUSTRY

Principal Investigators

  • Tim Ziegenfuss, Ph.D., FISSN, CSCS · Center for Applied Health Sciences

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2025-04-26
Completion
2025-04-26

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07527286 on ClinicalTrials.gov