IBS - Irritable Bowel SyndromeNCT05418439
Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
A study testing Drink Poppi Soda in people with IBS - Irritable Bowel Syndrome, run by Drink Poppi at 1 site in United States.
Trial summary
This exploratory observational trial provides the opportunity to gather information on the effect of daily consumption of Poppi Apple Cider Vinegar Prebiotic Soda on gut health and digestion. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Drink Poppi Soda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 May 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45
- Male or Female
- Must be in generally good health
- BMI under 35
- Self-reported issues with gas, bloating, heartburn/acid reflux, abdominal pain or digestion
- Willing to maintain their standard dietary pattern, activity level and body weight for the duration of the study
Who cannot join
- Severe chronic conditions, including oncological conditions or psychiatric disease
- Currently pregnant, wanting to become pregnant, or breastfeeding for the duration of the study
- Taking any prescription medication targeting the gut
- Taking any supplements targeting the gut in the past month
- Use of antibiotics in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This exploratory observational trial provides the opportunity to gather information on the effect of daily consumption of Poppi Apple Cider Vinegar Prebiotic Soda on gut health and digestion.
Read the detailed description
Individuals aged 18+ with a BMI under 30 and self-reported regular issues with IBS and/or poor digestion symptoms, including bloating, gassiness, heartburn, abdominal pain, constipation or associated symptoms (self-reported), but otherwise healthy will be chosen to participate in the study (see "4. Participant Definition"). Participants will be advised to discontinue any other oral supplement targeting the gut, including antibiotics, during the study and at least 3 months prior to.
Participants will be asked to complete the baseline survey on gut and skin health before the study starts.
Participants will also be asked to discontinue any additional soda consumption during the study.
Each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of Poppi ACV prebiotic soda.
After 2 full weeks (day 14 of the study period) of drinking Poppi daily, participants will complete the 2-week follow up survey of gut and skin health.
After four weeks (day 28) of the study period, participants will complete the 4-week end-of-study follow up survey of gut and skin health. Making the whole study period four weeks.
The gut health surveys completed at baseline, week two and week four will be evaluated to determine the impact of Poppi ACV prebiotic soda on symptoms of poor gut health/digestion/IBS, including bloating, gas, heartburn, constipation and abdominal pain, as well as skin health.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Drink Poppi Soda
- Keywords
- bloating, abdominal pain, gassiness, heartburn
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drink Poppi SodaDietary supplement
Drink Poppi Vinager Soda
| Study group | Role | What they receive |
|---|---|---|
| Poppi ACV prebiotic soda | Experimental | Each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of Poppi ACV prebiotic soda. Receives: Dietary Supplement: Drink Poppi Soda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IBS symptoms [Time Frame: Baseline to 4 weeks)
Survey-based assessment (0-5 scale) of changes in IBS symptoms with higher scores representing an improved outcome.
Measured: 4 weeks
Change in bowel movements [Time Frame: Baseline to 4 weeks)
Survey-based assessment (0-5 scale) of changes in stool frequency and consistency (constipation vs. diarrhea vs. normal) with higher scores representing an improved outcome.
Measured: 4 weeks
Change in skin health [Time Frame: Baseline to 4 weeks)
Survey-based assessment (0-5 scale) of changes in perceived skin health with higher scores representing an improved outcome.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Apr 2022
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drink Poppi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418439
- Sponsor's protocol ID
- 20229 Poppi
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
- ClinicalTrials.gov ID
- NCT05418439
- Acronym / sponsor ID
- 20229 Poppi
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- bloating, abdominal pain, gassiness, heartburn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Drink PoppiIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 14 Jun 2022 (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 exploratory observational trial provides the opportunity to gather information on the effect of daily consumption of Poppi Apple Cider Vinegar Prebiotic Soda on gut health and digestion.
Detailed description
Individuals aged 18+ with a BMI under 30 and self-reported regular issues with IBS and/or poor digestion symptoms, including bloating, gassiness, heartburn, abdominal pain, constipation or associated symptoms (self-reported), but otherwise healthy will be chosen to participate in the study (see "4. Participant Definition"). Participants will be advised to discontinue any other oral supplement targeting the gut, including antibiotics, during the study and at least 3 months prior to.
Participants will be asked to complete the baseline survey on gut and skin health before the study starts.
Participants will also be asked to discontinue any additional soda consumption during the study.
Each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of Poppi ACV prebiotic soda.
After 2 full weeks (day 14 of the study period) of drinking Poppi daily, participants will complete the 2-week follow up survey of gut and skin health.
After four weeks (day 28) of the study period, participants will complete the 4-week end-of-study follow up survey of gut and skin health. Making the whole study period four weeks.
The gut health surveys completed at baseline, week two and week four will be evaluated to determine the impact of Poppi ACV prebiotic soda on symptoms of poor gut health/digestion/IBS, including bloating, gas, heartburn, constipation and abdominal pain, as well as skin health.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poppi ACV prebiotic soda | Experimental | Dietary Supplement: Drink Poppi SodaEach day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of Poppi ACV prebiotic soda. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-45
- Male or Female
- Must be in generally good health
- BMI under 35
- Self-reported issues with gas, bloating, heartburn/acid reflux, abdominal pain or digestion
Key exclusion criteria (5 listed)
- Severe chronic conditions, including oncological conditions or psychiatric disease
- Currently pregnant, wanting to become pregnant, or breastfeeding for the duration of the study
- Taking any prescription medication targeting the gut
- Taking any supplements targeting the gut in the past month
- Use of antibiotics in the past 3 months
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 |
|---|---|---|
| Drink Poppi SodaDrink Poppi Vinager Soda | Dietary supplement | Poppi ACV prebiotic soda |
Primary outcome
Change in IBS symptoms [Time Frame: Baseline to 4 weeks)
Time frame: 4 weeks
Survey-based assessment (0-5 scale) of changes in IBS symptoms with higher scores representing an improved outcome.
Change in bowel movements [Time Frame: Baseline to 4 weeks)
Time frame: 4 weeks
Survey-based assessment (0-5 scale) of changes in stool frequency and consistency (constipation vs. diarrhea vs. normal) with higher scores representing an improved outcome.
Change in skin health [Time Frame: Baseline to 4 weeks)
Time frame: 4 weeks
Survey-based assessment (0-5 scale) of changes in perceived skin health with higher scores representing an improved outcome.
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 15 Jun 2022.
- Individual participant dataSharing planned: No
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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 Drink Poppi Soda in people with IBS - Irritable Bowel Syndrome, run by Drink Poppi 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 6 inclusion and 5 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 15 Jun 2022. 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?
Change in IBS symptoms [Time Frame: Baseline to 4 weeks) (time frame: 4 weeks). The study lists 3 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 Jun 2022.