HealthyNCT06794619
Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement
A study testing Dietary Supplement with actives in people with Healthy, run by Olly, PBC at 1 site in United States.
Trial summary
Randomized, Crossover, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with Daily Food Log, Stool Samples, Blood Draws, and Validated Questionnaires (GSRS, Bristol stool chart, and DQLQ) with Oral Dietary Supplement Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary Supplement with actives
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a healthy male or female between the ages of 18 - 50 years, inclusive;
- Subject indicates they have mild or moderate occasional digestive issues (bloating or mild discomfort) with no diagnosed chronic digestive or immune conditions;
- Subject has signed a written Informed Consent and is willing and able to attend all visits and comply with study instructions;
- Subject agrees to maintain their regular diet and exercise habits;
- Subject agrees to limit alcohol consumption to 1 drink per day or no more than 7 drinks per week.
- Females Only: Female subject of childbearing potential must agree to be on a form of birth control for at least 6 months prior to screening visit. Acceptable forms of birth control are: Abstinence (not having heterosexual sex), same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), vasectomized partner for at least 6 months prior to the screening visit. Birth control (such as the pills, intravaginal ring, or the arm implant) are not acceptable forms of birth control.
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- Subject agrees not to take any dietary supplements or medications throughout the clinical study;
- Subject agrees to have four blood draws taken at the testing facility and agrees to collect stool samples (four times) as instructed.
- Subject has an active email address and is capable of completing online questionnaires.
Who cannot join
- Subject has severe digestive issues (e.g., IBS, Crohn's Disease, Ulcers, Severe Constipation, etc.);
- Subject has allergies to dietary supplements or their ingredients;
- Subject is currently taking medication(s) for a chronic condition;
- (Females of Child Bearing Potential only) Subject is pregnant, nursing, or planning to become pregnant;
- Subject has significant past/current medical history (e.g., previous diagnosis of gastrointestinal or metabolic conditions, cancer, liver or kidney disease);
- Subject has any disease or condition (e.g., hepatic, multiple sclerosis, high blood pressure, renal, Thrombosis/Phlebitis, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease) which in the opinion of the Investigator would compromise the safety of the subject;
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- Subject has travel plans and would be unable to attend all study visits;
- Subject is currently taking any dietary supplements, vitamins and/or medications;
- Subject is currently taking probiotics related to digestion or any products that may impact gut microbiota (e.g. probiotic supplements, yogurt, and/or fermented drinks);
- Subject has used antibiotics in the last 3 months;
- Subject has a positive medical history for cancer within the past 5 years;
- Subjects has any planned surgeries and/or invasive medical procedures during the study;
- Subjects is considered unreliable or unlikely to be available for the duration of the study;
- Subject is an employee of the clinical site or the sponsor
Trial locations and contacts
1 site in 1 country.
United States1 site
Princeton Consumer Research
St. Petersburg, Florida, 33702
About this study
Randomized, Crossover, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with Daily Food Log, Stool Samples, Blood Draws, and Validated Questionnaires (GSRS, Bristol stool chart, and DQLQ) with Oral Dietary Supplement
- Conditions
- Healthy
- Being tested
- Placebo, Dietary Supplement with actives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo
Dietary Supplement with activesDietary supplement
Dietary Supplement containing probiotic and prebiotic ingredients
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral dietary supplement. Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day. Receives: Dietary Supplement: Placebo |
| Dietary Supplement with actives | Active comparator | Oral dietary supplement. Instructions: Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day. Receives: Dietary Supplement: Dietary Supplement with actives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gastrointestinal Symptoms (GSRS) Scores
Weekly GSRS scores will be analyzed to assess changes in the severity and frequency of gastrointestinal symptoms across the active and placebo arms.
Data will be compared between the active supplement and placebo groups and within each participant across different time points to measure crossover effects.
Measured: from enrollment to end of study at 10 weeks
Changes in Stool Consistency (Bristol Stool Chart)
Daily stool consistency ratings will provide data on changes in bowel health and regularity.
Average stool consistency scores will be compared across baseline, active treatment, and placebo phases.
Measured: from enrollment to end of study at 10 weeks
Secondary outcomes (2)
Changes in Immune Biomarkers (Blood Samples) Levels
Blood sample analysis will focus on immune function biomarkers counts. Changes in immune biomarkers will be compared between baseline, active treatment, and placebo periods.
Measured: from enrollment to end of study at 10 weeks
Changes in Gut Microbiome Composition (Stool Samples)
Stool samples will be analyzed for changes in microbial diversity and specific bacterial populations, which may indicate changes in gut health.
Comparisons will be made between active treatment and placebo periods to identify any significant shifts in the microbiome.
Measured: from enrollment to end of study at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start3 Feb 2025
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olly, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794619
- Sponsor's protocol ID
- OLLCLI1F
- Status last verified
- Jul 2025
- First submitted
- 6 Jan 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Effects of Prebiotic and Probiotic Supplement
- ClinicalTrials.gov ID
- NCT06794619
- Acronym / sponsor ID
- OLLCLI1F
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Olly, PBCIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 27 Jan 2025 (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.
Randomized, Crossover, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with Daily Food Log, Stool Samples, Blood Draws, and Validated Questionnaires (GSRS, Bristol stool chart, and DQLQ) with Oral Dietary Supplement
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOral dietary supplement. Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day. |
| Dietary Supplement with actives | Active comparator | Dietary Supplement: Dietary Supplement with activesOral dietary supplement. Instructions: Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject is a healthy male or female between the ages of 18 - 50 years, inclusive;
- Subject indicates they have mild or moderate occasional digestive issues (bloating or mild discomfort) with no diagnosed chronic digestive or immune conditions;
- Subject has signed a written Informed Consent and is willing and able to attend all visits and comply with study instructions;
- Subject agrees to maintain their regular diet and exercise habits;
- Subject agrees to limit alcohol consumption to 1 drink per day or no more than 7 drinks per week.
Key exclusion criteria (14 listed)
- Subject has severe digestive issues (e.g., IBS, Crohn's Disease, Ulcers, Severe Constipation, etc.);
- Subject has allergies to dietary supplements or their ingredients;
- Subject is currently taking medication(s) for a chronic condition;
- (Females of Child Bearing Potential only) Subject is pregnant, nursing, or planning to become pregnant;
- Subject has significant past/current medical history (e.g., previous diagnosis of gastrointestinal or metabolic conditions, cancer, liver or kidney disease);
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 |
|---|---|---|
| PlaceboPlacebo | Dietary supplement | Placebo |
| Dietary Supplement with activesDietary Supplement containing probiotic and prebiotic ingredients | Dietary supplement | Dietary Supplement with actives |
Primary outcome
Changes in Gastrointestinal Symptoms (GSRS) Scores
Time frame: from enrollment to end of study at 10 weeks
Weekly GSRS scores will be analyzed to assess changes in the severity and frequency of gastrointestinal symptoms across the active and placebo arms. Data will be compared between the active supplement and placebo groups and within each participant across different time points to measure crossover effects.
Changes in Stool Consistency (Bristol Stool Chart)
Time frame: from enrollment to end of study at 10 weeks
Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases.
2 secondary outcomes
Changes in Immune Biomarkers (Blood Samples) Levels
Time frame: from enrollment to end of study at 10 weeks
Changes in Gut Microbiome Composition (Stool Samples)
Time frame: from enrollment to end of study at 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement with actives in people with Healthy, run by Olly, PBC 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 9 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in Gastrointestinal Symptoms (GSRS) Scores (time frame: from enrollment to end of study at 10 weeks). The study lists 2 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 15 Jul 2025.