HealthyNCT07033000
A Randomized, Placebo Controlled Clinical Study to Assess the Effect of a Blend of Digestive Enzymes and Extracts on Bloating in Adults.
A study testing Dietary Supplement with actives in people with Healthy, run by Olly, PBC at 1 site in United States.
Trial summary
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study, where participants will take the Daily Supplement, and record Daily Symptoms, two clinical visits where Hydrogen and Methane Breath Test (HMBT) will be conducted, Abdominal Circumference Measurement will be taken, and two Self Reported… Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 15 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Adults aged 18-65 years
- Reported bloating and/or distention occurring at least once per week for the past 6 months, with symptoms actively present during the past 3 months
- Willingness to avoid probiotics, antibiotics, or other supplements during the study period (unless approved by investigators)
- Ability to provide informed consent and comply with all protocol requirements
Who cannot join
- Diagnosed gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, GI malignancies)
- Use of antibiotics, laxatives, or probiotics within the past 4 weeks
- Uncontrolled diabetes mellitus
- Presence of mood disorders or psychiatric illness that may affect symptom perception or study compliance
- Immunodeficiency, autoimmune conditions, or chronic inflammatory conditions
- Excessive alcohol intake (>14 drinks/week for men, >7 drinks/week for women)
Show all 12Show fewer
- Use of medications known to affect gut motility or gas production (e.g., opioids, anticholinergics)
- Pregnant or breastfeeding women
- Use of systemic corticosteroids or immunosuppressant drugs.
- History of reaction to the category of product tested
- Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
- Employee of CRO or product manufacturer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MusB Research
New Port Richey, Florida, 34653
Hariom Yadav, 240-899-5859, yadavh@musbresearch.com
About this study
Official title: A Randomized, Placebo Controlled Clinical Study to Assess the Effect of a Blend of Digestive Enzymes andDandelion, Ginger & Fennel Extracts on Bloating in Adults.
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study, where participants will take the Daily Supplement, and record Daily Symptoms, two clinical visits where Hydrogen and Methane Breath Test (HMBT) will be conducted, Abdominal Circumference Measurement will be taken, and two Self Reported Validated Questionnaires: Visual Analogue Scale (VAS) and the Quality of Life Questionnaires.
- 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 blend of Digestive Enzymes, Dandelion, Ginger \& Fennel Extracts
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3. Receives: Dietary Supplement: Placebo |
| Dietary Supplement with actives | Active comparator | Oral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3. Receives: Dietary Supplement: Dietary Supplement with actives |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the impact of BTB on hydrogen and methane production in healthy adults
Participants will take the Hydrogen and Methane Breath Test (HMBT) at baseline and after the study at Week4.
Measured: From time of enrollement to end of study at Week4
Secondary outcomes (2)
To estimate the changes in abdominal circumference as an indicator of distention
Standardized tape measurement at the level of the iliac crest or on top of belly button will be used to evaluate changes in abdominal distention at baseline and after the study at Week4.
Measured: From time of enrollement to end of study at Week4
To assess the changes in validated subjective questionnaire (VAS) for bloating, abdominal pain, distension, and flatulence.
Participants will take Visual Analogue Scale (VAS) which is a self-reported assessment of bloating and distention severity using PROMIS's GI gas and bloating questionnaire at baseline and after the study at Week4.
Measured: From time of enrollement to end of study at Week4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start14 Jul 2025 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion15 Sep 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olly, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033000
- Sponsor's protocol ID
- ULOLLYBTB2
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jun 2025
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Clinical Study to Assess the Effect of a Blend of Digestive Enzymes andDandelion, Ginger & Fennel Extracts on Bloating in Adults.
- ClinicalTrials.gov ID
- NCT07033000
- Acronym / sponsor ID
- ULOLLYBTB2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Olly, PBCIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 24 Jun 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, Double-Blind, Placebo-Controlled, Single-Center Clinical Study, where participants will take the Daily Supplement, and record Daily Symptoms, two clinical visits where Hydrogen and Methane Breath Test (HMBT) will be conducted, Abdominal Circumference Measurement will be taken, and two Self Reported Validated Questionnaires: Visual Analogue Scale (VAS) and the Quality of Life Questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3. |
| Dietary Supplement with actives | Active comparator | Dietary Supplement: Dietary Supplement with activesOral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy Adults aged 18-65 years
- Reported bloating and/or distention occurring at least once per week for the past 6 months, with symptoms actively present during the past 3 months
- Willingness to avoid probiotics, antibiotics, or other supplements during the study period (unless approved by investigators)
- Ability to provide informed consent and comply with all protocol requirements
Key exclusion criteria (12 listed)
- Diagnosed gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, GI malignancies)
- Use of antibiotics, laxatives, or probiotics within the past 4 weeks
- Uncontrolled diabetes mellitus
- Presence of mood disorders or psychiatric illness that may affect symptom perception or study compliance
- Immunodeficiency, autoimmune conditions, or chronic inflammatory conditions
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 blend of Digestive Enzymes, Dandelion, Ginger \& Fennel Extracts | Dietary supplement | Dietary Supplement with actives |
Primary outcome
To determine the impact of BTB on hydrogen and methane production in healthy adults
Time frame: From time of enrollement to end of study at Week4
Participants will take the Hydrogen and Methane Breath Test (HMBT) at baseline and after the study at Week4.
2 secondary outcomes
To estimate the changes in abdominal circumference as an indicator of distention
Time frame: From time of enrollement to end of study at Week4
To assess the changes in validated subjective questionnaire (VAS) for bloating, abdominal pain, distension, and flatulence.
Time frame: From time of enrollement to end of study at Week4
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 24 Jun 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.
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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 24 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the impact of BTB on hydrogen and methane production in healthy adults (time frame: From time of enrollement to end of study at Week4). 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 24 Jun 2025.