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NCT07527286 · ClinicalTrials.gov registry record
The Effects of a Postbiotic Supplement on Biomarkers of Gut Health
A clinical trial, sponsored by Verb Biotics.
- Completed
- Registry status
- 76
- Enrollment target
NCT07527286: Completed study, sponsored by Verb Biotics.
NCT07527286 is a clinical trial that has completed, run by Verb Biotics. The registered enrollment target is 76 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07527286 has completed, sponsored by Verb Biotics.
- COMPLETED
- Registry status
- 76 participants
- Enrollment target
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.
Primary Outcome
The primary outcome is to observe a change in the fecal microbial populations in between the postbiotic group and the placebo control group from intake and baseline to the end of the study period. This will be measured by a change in fecal microbial populations by DNA analysis at the genus, species and strain level (where possible) between the placebo and study group. Baseline period will be compared as well. Both alpha and beta diversity will be assessed as well.
Interventions
- DIETARY_SUPPLEMENT Postbiotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2024-11-05 |
| Est. Completion | 2025-04-26 |
What the finished NCT07527286 record still lists
NCT07527286 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 76 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Postbiotic is the first listed.
NCT07527286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07527286 about?
NCT07527286 is a clinical study titled "The Effects of a Postbiotic Supplement on Biomarkers of Gut Health". 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 e...
What is the current status of trial NCT07527286?
This trial is currently completed. The enrollment target is 76 participants. The study started on 2024-11-05. Estimated completion is 2025-04-26.
What interventions are being tested in trial NCT07527286?
The interventions under investigation include: Postbiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07527286?
This trial is sponsored by Verb Biotics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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