HealthyNCT06808867
Efficacy of Dietary Supplement in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and GI Symptoms
A study testing Dietary Supplement with Active Ingredient Blend in people with Healthy, run by Olly, PBC at 1 site in United States.
Trial summary
This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary Supplement with Active Ingredient Blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2024to 15 Apr 2024
- Phase
- Interventional
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent to participate in the study.
- Willingness to actively participate in the study and to come to the scheduled visits.
- Female and/or male
- From 18 to 85 years of age
- Patients with self-reported abdominal bloating, abdominal distention, flatulence, and abdominal discomfort either after meals or not at least 3x a week for a minimum of the past 2 weeks
Who cannot join
- Drug addicts, alcoholics.
- AIDS, HIV-positive or infectious hepatitis
- Diabetes mellitus
- Disorders known to affect GI motility such as gastroparesis or amyloidosis.
- Disorders with GI symptoms such as irritable bowel syndrome, inflammatory bowel disease and celiac disease
- History of surgery known to alter the normal function of the GI tract.
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- Conditions which exclude participation or might influence the test reaction/evaluation.
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
- Documented allergies to cosmetic products and/or ingredients
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) within the last 6 weeks prior to the start of the study and/or throughout the entire course of the study.
- Oral steroids within the last 4 weeks prior to the start of the study and/or throughout the entire course of the study
- Oral or systemic therapy with antibiotics within the last 3 months prior to the start of the study and/or throughout the entire course of the study
- Subjects who were treated with biologics within the last 6 months prior to the start of the study and/or throughout the entire course of the study.
- One of the following illnesses if not medicated: cardiovascular diseases, thyroid hyperfunction, asthma, hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 6-week Randomized, Double-blind, Comparative Clinical Study of the Efficacy of an Oral Product in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and Gastrointestinal Symptoms
This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study.
Study Primary Objective:
- To assess improvement in bloating symptoms
Study Secondary Objectives:
- To assess safety and tolerability of the formulation
- To compare the time taken for perceptual improvement in bloating/distention
- Enzyme blood assays
- To assess quality of life indices
- Conditions
- Healthy
- Being tested
- Placebo, Dietary Supplement with Active Ingredient Blend
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Eligible subjects will receive Placebo to take daily for six weeks
Dietary Supplement with Active Ingredient BlendDietary supplement
Eligible subjects will receive Active supplement to take daily for six weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning. Receives: Dietary Supplement: Placebo |
| Dietary Supplement with Active Ingredient Blend | Active comparator | Oral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning. Receives: Dietary Supplement: Dietary Supplement with Active Ingredient Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Digestive Quality of Life Questionnaire (DQLQ) scores
To assess changes in scores related to bloating, diarrhea, constipation and heartburn on quality-of-life indicators, comparing active supplement to placebo group
Measured: from enrollment to end of study at 8 weeks
Changes in Symptom Severity Score (Diary)
Patients filled out the symptoms diary that had questionnaires of bowel habits. Abdominal pain and bloating were rated on a 100-point visual analogue scale with 0=none and 100=severe, comparing active supplement to placebo group
Measured: from enrollment to end of study at 8 weeks
Secondary outcomes (2)
Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores
To assess changes in gastrointestinal symptoms comparing active supplement to placebo group
Measured: from enrollment to end of study at 8 weeks
Changes in Stool Consistency (Bristol Stool Scale)
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 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start25 Feb 2024
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 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
- NCT06808867
- Sponsor's protocol ID
- UNLV20231116
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-week Randomized, Double-blind, Comparative Clinical Study of the Efficacy of an Oral Product in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT06808867
- Acronym / sponsor ID
- UNLV20231116
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Olly, PBCIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 5 Feb 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.
This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study.
Study Primary Objective:
- To assess improvement in bloating symptoms
Study Secondary Objectives:
- To assess safety and tolerability of the formulation
- To compare the time taken for perceptual improvement in bloating/distention
- Enzyme blood assays
- To assess quality of life indices
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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: Subjects were instructed to take the product (1 pill) with a glass of water in the morning. |
| Dietary Supplement with Active Ingredient Blend | Active comparator | Dietary Supplement: Dietary Supplement with Active Ingredient BlendOral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent to participate in the study.
- Willingness to actively participate in the study and to come to the scheduled visits.
- Female and/or male
- From 18 to 85 years of age
- Patients with self-reported abdominal bloating, abdominal distention, flatulence, and abdominal discomfort either after meals or not at least 3x a week for a minimum of the past 2 weeks
Key exclusion criteria (15 listed)
- Drug addicts, alcoholics.
- AIDS, HIV-positive or infectious hepatitis
- Diabetes mellitus
- Disorders known to affect GI motility such as gastroparesis or amyloidosis.
- Disorders with GI symptoms such as irritable bowel syndrome, inflammatory bowel disease and celiac 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 |
|---|---|---|
| PlaceboEligible subjects will receive Placebo to take daily for six weeks | Dietary supplement | Placebo |
| Dietary Supplement with Active Ingredient BlendEligible subjects will receive Active supplement to take daily for six weeks | Dietary supplement | Dietary Supplement with Active Ingredient Blend |
Primary outcome
Changes in Digestive Quality of Life Questionnaire (DQLQ) scores
Time frame: from enrollment to end of study at 8 weeks
To assess changes in scores related to bloating, diarrhea, constipation and heartburn on quality-of-life indicators, comparing active supplement to placebo group
Changes in Symptom Severity Score (Diary)
Time frame: from enrollment to end of study at 8 weeks
Patients filled out the symptoms diary that had questionnaires of bowel habits. Abdominal pain and bloating were rated on a 100-point visual analogue scale with 0=none and 100=severe, comparing active supplement to placebo group
2 secondary outcomes
Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores
Time frame: from enrollment to end of study at 8 weeks
Changes in Stool Consistency (Bristol Stool Scale)
Time frame: from enrollment to end of study at 8 weeks
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 5 Feb 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 Active Ingredient Blend 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 5 inclusion and 15 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 5 Feb 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?
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?
Changes in Digestive Quality of Life Questionnaire (DQLQ) scores (time frame: from enrollment to end of study at 8 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 5 Feb 2025.