HealthyNCT04097106
Synbiotic Dietary Supplement and Gut Microbiota
An observational study of Healthy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Synbiotic
- Type of treatment
- Pill or oral medicine
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2020to 27 Jun 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Thirty two healthy volunteers, aged 18-45 years old, will be recruited for this pilot study, plan to enroll 16 subjects with a BMI 19-25 kg/m2 and 16 subjects with a BMI 30-35 kg/m2.
Who may be able to join
- BMI 19-25 (lean) and BMI 30-35 (obese)
- Age 18-45 years old
- subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,
- willing to complete gastrointestinal (GI) and dietary surveys, body composition assessment, and provide blood, urine and stool sample at 4 intervals during the pilot study (baseline, after first supplementation period (day 28), after washout period (day 49), and after second supplementation period (day 77)
Who cannot join
- antibiotic consumption within 28 days of study initiation
- diabetes
- kidney disorders
- history of cardiac disease and medications for cardiac disease
- use of statins and antihypertensive drugs
- inflammatory bowel disease
Show all 14Show fewer
- irritable bowel syndrome
- history of small intestinal bacterial overgrowth
- history of intestinal surgery, excluding hernia repair and appendectomy
- active cancer diagnosis; chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
- immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
- abnormal liver or kidney function as measured by routine serum chemistry testing
- severe anemia or significant white blood cell or platelet abnormalities
- no additional blood or blood product donations during study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synbiotic Supplement Effects on Gastrointestinal Symptoms and Gut Microbiota and Fecal Metabolomics
To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.
Read the detailed description
This will be a double-blinded, randomized, placebo-controlled paired crossover pilot study in healthy controls aimed to evaluate gastrointestinal tolerance of a synbiotic dietary supplement.
- Conditions
- Healthy
- Being tested
- Synbiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
Synbiotic dietary supplement in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Lean BMI (19-25) | Not described Receives: Dietary Supplement: Synbiotic | |
| Obese BMI (30-35) | Not described Receives: Dietary Supplement: Synbiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure change in gastrointestinal symptoms using "Rating of Gastrointestinal (GI) Symptoms" scale
Rating of GI Symptoms scale includes 5 questions, which range from 0 (never affected) to 7 (always bothered), summed to compute total score
Measured: Baseline, Day 28, day 49, day 77
Change in microbiome stool diversity
Measured: Baseline, Day 28, day 49, day 77
Change in metabolome stool profile
Measured: Baseline, Day 28, day 49, day 77
Change in metabolome urine profile
Measured: Baseline, Day 28, day 49, day 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start10 Nov 2020
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Cresci, The Cleveland Clinic
- Investigators
- Gail Cresci, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097106
- Sponsor's protocol ID
- IRB #19-601
- Status last verified
- Dec 2024
- First submitted
- 18 Sep 2019
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synbiotic Supplement Effects on Gastrointestinal Symptoms and Gut Microbiota and Fecal Metabolomics
- ClinicalTrials.gov ID
- NCT04097106
- Acronym / sponsor ID
- IRB #19-601
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 20 Sep 2019 (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.
To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.
Detailed description
This will be a double-blinded, randomized, placebo-controlled paired crossover pilot study in healthy controls aimed to evaluate gastrointestinal tolerance of a synbiotic dietary supplement.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean BMI (19-25) | – | Dietary Supplement: Synbiotic |
| Obese BMI (30-35) | – | Dietary Supplement: Synbiotic |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Thirty two healthy volunteers, aged 18-45 years old, will be recruited for this pilot study, plan to enroll 16 subjects with a BMI 19-25 kg/m2 and 16 subjects with a BMI 30-35 kg/m2.
Key inclusion criteria (4 listed)
- BMI 19-25 (lean) and BMI 30-35 (obese)
- Age 18-45 years old
- subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,
- willing to complete gastrointestinal (GI) and dietary surveys, body composition assessment, and provide blood, urine and stool sample at 4 intervals during the pilot study (baseline, after first supplementation period (day 28), after washout period (day 49), and after second supplementation period (day 77)
Key exclusion criteria (14 listed)
- antibiotic consumption within 28 days of study initiation
- diabetes
- kidney disorders
- history of cardiac disease and medications for cardiac disease
- use of statins and antihypertensive drugs
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 |
|---|---|---|
| SynbioticSynbiotic dietary supplement in capsule form | Dietary supplement | Lean BMI (19-25), Obese BMI (30-35) |
Primary outcome
Measure change in gastrointestinal symptoms using "Rating of Gastrointestinal (GI) Symptoms" scale
Time frame: Baseline, Day 28, day 49, day 77
Rating of GI Symptoms scale includes 5 questions, which range from 0 (never affected) to 7 (always bothered), summed to compute total score
Change in microbiome stool diversity
Time frame: Baseline, Day 28, day 49, day 77
Change in metabolome stool profile
Time frame: Baseline, Day 28, day 49, day 77
Change in metabolome urine profile
Time frame: Baseline, Day 28, day 49, day 77
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 9 Dec 2024.
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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.
Gail Cresci principal investigator
The Cleveland Clinic
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 Healthy, run by The Cleveland Clinic 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 4 inclusion and 14 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 9 Dec 2024. 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?
Measure change in gastrointestinal symptoms using "Rating of Gastrointestinal (GI) Symptoms" scale (time frame: Baseline, Day 28, day 49, day 77). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.