GastrointestinalNCT07527286
The Effects of a Postbiotic Supplement on Biomarkers of Gut Health
An observational study of Gastrointestinal and Microbiota Balance, run by Verb Biotics LLC at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal, Microbiota Balance, Microbiota
- What is being tested?
- Postbiotic
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 26 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Apparently healthy men and women between 18 and 65 years old, located in Northeast Ohio.
Who may be able to join
- Provide voluntary signed and dated informed consent. • Be in good health as determined by medical history and routine blood chemistries.
- Age between 18 and 65 years (inclusive).
- Body Mass Index of 18.5-34.9 (inclusive).
- Body weight of at least 110 pounds.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the participant will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- Normal seated, resting heart rate (<90 per minute).
Show all 11Show fewer
- Willing to duplicate their previous 24-hour diet, refrain from caffeine for 24 hours, abstain from exercise for 48 hours prior, and fast for 10 hours prior to each laboratory visit.
- Participant agrees to maintain existing dietary and physical activity patterns throughout the study period.
- Participant is willing and able to comply with the study protocol.
- No medical history of gastrointestinal distress.
- Avoidance of cultured and fermented foods such as yogurt, kefir, kombucha during the duration of the study.
Who cannot join
- Current use of prebiotics, probiotics, postbiotics, or antibiotics within the past 4 weeks or use of any dietary supplement that may confound the study or its endpoints.
- Current use of GLP-1 inhibitors. • Individuals that adhere to a vegan diet.
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
- Current or previous diagnosis of prediabetes, diabetes, or an endocrine disorder.
- Fasting blood glucose of > 125 mg/dL.
- Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
Show all 20Show fewer
- Current smokers or smoking within the past month.
- Current use of aspirin, or pharmaceuticals impacting mucin such as, but not limited to Mucinex (guaifenesin).
- History of hyperparathyroidism or an untreated thyroid disease.
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Prior gastrointestinal bypass surgery (Lapband), etc.
- Being treated for or having other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, IBS/IBD, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's disease, ulcerative colitis, IBS/IBD, Lupus, HIV/AIDS, etc.).
- Previous medical diagnosis of gout or fibromyalgia.
- Individuals who are cognitively impaired and/or who are unable to give informed consent.
- Pregnant, trying to become pregnant, less than 120 days postpartum, or are nursing. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to take a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent.
- Clinically significant abnormal laboratory results at screening.
- Known sensitivity to any ingredient in the test formulations as listed in the study product.
- Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the participant at increased risk of harm if they were to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
Official title: The Effects of a Postbiotic Supplement on Biomarkers of Gastrointestinal, Cardiometabolic and Immunometabolic 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 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.
Read more
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, Microbiota Balance, Microbiota, Cortisol, Butyrate, Bloating
- Being tested
- Postbiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostbioticDietary supplement
300mg
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. Receives: Dietary Supplement: Postbiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in fecal microbiome diversity.
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.
Measured: Participants will complete up to 5-week study consisting from screening, randomization, and enrollment periods to the end of treatment at 4 weeks
Secondary outcomes (6)
Evaluate the impact of a Postbiotic on short chain fatty acid production
A secondary outcome is to evaluate the impact of keystone postbiotic on short chain fatty acid production. This will be measured by a change in the SCFA profile in fecal samples as assessed by GC/MS, between placebo control group and the postbiotic group. Blood samples will also be taken to evaluate circulating butyrate levels between placebo control group and the postbiotic group. GCMS detection is determined by peak area values. Higher values at the end of the trial suggest more SCFA are being produced.
Measured: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on serum zonulin
A secondary outcome is to evaluate the impact of keystone postbiotic on serum zonulin. This will be measured by a change in numerical value of zonulin (ng/ml) between the placebo and study group as well as a change from baseline to the end of the study at 4-weeks. Higher values of serum zonulin suggest increased permeability of the intestinal epithelium.
Measured: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on salivary cortisol.
A secondary outcome is to evaluate the impact of the postbiotic on salivary cortisol as a measure of stress. This will be measured by a change in salivary cortisol (ug/dL) between placebo and study product group. Baseline period will be assessed as well. Higher levels of salivary cortisol suggest more stress (physical, immune related or psychological) which is a worse outcome.
Measured: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on Quality of Life
A secondary outcome will be measured by a change in the SF-36 (36-Item Short Form Survey) score between placebo and study product group to assess quality of life. Baseline period will be compared as well. On a scale between 0-100, a higher SF-36 score indicates better health.
Measured: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on emotional state.
A secondary outcome is to evaluate the impact of the postbiotic on emotional health. This will be assessed by a change in the DASS-21 (depression, anxiety and stress -21 items) assessment. On a scale between 0-42, a higher DASS-21 score indicates more severe emotional distress, which is a worse outcome.
Measured: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on gastointestinal health
A secondary outcome is to evaluate the impact of the postbiotic on gastrointestinal health. This will be measured by a change in the GSRS (gastrointestinal symptoms rating scale) score between placebo and study product groups. Baseline period will be compared as well. On a scale of 15-105, a higher GSRS score indicates more severe symptoms, which is a worse outcome.
Measured: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start5 Nov 2024
- Primary completion26 Apr 2025
- Study completion26 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastrointestinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verb Biotics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Ziegenfuss, Ph.D., FISSN, CSCS, Principal investigator, Center for Applied Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527286
- Sponsor's protocol ID
- VERB-0924-005
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delebecque CJ, La Monica MB, Keller D, Shannon W, Ziegenfuss TN, Zimmerman NP. The effects of a postbiotic supplement on biomarkers of microbiome, gastrointestinal, cardiometabolic, and immunometabolic health. Benef Microbes. 2026 Jul 20:1-14. doi: 10.1163/18762891-bja00129. Online ahead of print.
PubMed 42486470
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Postbiotic Supplement on Biomarkers of Gastrointestinal, Cardiometabolic and Immunometabolic Health
- ClinicalTrials.gov ID
- NCT07527286
- Acronym / sponsor ID
- VERB-0924-005
- Conditions
- Gastrointestinal, Microbiota Balance, Microbiota, Cortisol, Butyrate, Bloating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Verb Biotics LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 26 Apr 2025 (actual)
- Study completion
- 26 Apr 2025 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Postbiotic Study Product | – | Dietary Supplement: PostbioticParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Apparently healthy men and women between 18 and 65 years old, located in Northeast Ohio.
Key inclusion criteria (11 listed)
- Provide voluntary signed and dated informed consent. • Be in good health as determined by medical history and routine blood chemistries.
- Age between 18 and 65 years (inclusive).
- Body Mass Index of 18.5-34.9 (inclusive).
- Body weight of at least 110 pounds.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the participant will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
Key exclusion criteria (20 listed)
- Current use of prebiotics, probiotics, postbiotics, or antibiotics within the past 4 weeks or use of any dietary supplement that may confound the study or its endpoints.
- Current use of GLP-1 inhibitors. • Individuals that adhere to a vegan diet.
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
- Current or previous diagnosis of prediabetes, diabetes, or an endocrine disorder.
- Fasting blood glucose of > 125 mg/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postbiotic300mg | Dietary supplement | Postbiotic Study Product |
Primary outcome
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
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.
6 secondary outcomes
Evaluate the impact of a Postbiotic on short chain fatty acid production
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on serum zonulin
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on salivary cortisol.
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on Quality of Life
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on emotional state.
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Evaluate the impact of keystone postbiotic on gastointestinal health
Time frame: Participants will complete the trial from enrollment to the end of the 4-week treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 42486470Delebecque CJ, La Monica MB, Keller D, Shannon W, Ziegenfuss TN, Zimmerman NP. The effects of a postbiotic supplement on biomarkers of microbiome, gastrointestinal, cardiometabolic, and immunometabolic health. Benef Microbes. 2026 Jul 20:1-14. doi: 10.1163/18762891-bja00129. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Ziegenfuss, Ph.D., FISSN, CSCS principal investigator
Center for Applied Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal and Microbiota Balance, run by Verb Biotics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07527286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.