Digestive HealthNCT07516587
Study to Investigate the Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants
A study testing Bloat Gummies in people with Digestive Health and Abdominal Discomfort, run by Arrae at 1 site in United States.
Trial summary
The goal of this crossover clinical trial is to evaluate the efficacy and safety of Bloat Gummies on postprandial bloating and related gastrointestinal discomfort in healthy adults with recurrent bloating. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Health, Abdominal Discomfort, Gas and Bloating
- What is being tested?
- Bloat Gummies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Oct 2026
- 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 male and female individuals aged 18-65 years at time of screening.
- Body mass index (BMI) <29.9 kg/m².
- Self-reported recurrent postprandial abdominal bloating and/or distension occurring on average at least 2 days per week over the past 3 months, predominating over other gastrointestinal (GI) symptoms, and in the absence of a diagnosed gastrointestinal disease.
- Females of child-bearing potential must have a negative baseline pregnancy test and agree to use a medically approved method of birth control for the duration of the study.
- Willing to consume a standardized test meal consisting of 2 slices of large cheese pizza from Dominos on each test day.
- Willing to complete online surveys and at-home measurements (waist circumference) at scheduled time points.
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- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study.
- Provides voluntary, written, informed consent to participate in the study prior to any study procedures.
- Has reliable access to internet and a smartphone or computer capable of completing electronic surveys and attending virtual check-ins.
Who cannot join
- Current or past diagnosis of any significant disease of the GI tract, including but not limited to: irritable bowel syndrome (IBS), celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), functional constipation, gastroesophageal reflux disease (GERD), gastroparesis, or treatment for H. pylori infection or gastric ulcer within the past year.
- Significant or untreated medical and/or psychiatric disorders, including but not limited to: severe unstable diabetes, recent myocardial ischemia or infarction, unstable angina, cancer (except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative or volunteers with cancer in full remission for more than five years after diagnosis are acceptable), uncontrolled hypertension, renal failure, chronic active hepatitis, acute hepatitis, cirrhosis, Acquired Immunodeficiency Syndrome (AIDS), malignancy, and neurological disorders including epilepsy, recent cerebrovascular disease, or recent traumatic brain injury.
- Current use of digestive enzyme supplements, prebiotics/fibers, probiotics, postbiotics, bloating-targeted supplements, therapeutic iron supplementation (>65 mg elemental iron per dose), prokinetic agents, antacids, H2 blockers, proton pump inhibitors (PPIs), opioids, or loperamide within 14 days prior to the first test meal session; or use of any of the above during the study period.
- Esophageal obstruction or difficulty swallowing.
- Wear dentures.
- Pregnant, breastfeeding, or planning to become pregnant during the study.
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- Known allergy, or sensitivity to any ingredient of the study supplement or placebo, including ginger, lemon balm, dandelion, or Bifidobacterium longum-derived products.
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of standardized meal ingredients.
- Alcohol use disorder or drug abuse/dependence within the past 6 months (>2 standard drinks/day on average).
- Currently following an extremely restrictive diet or having done so within the past 3 months.
- Participation in another clinical research trial within 30 days prior to randomization.
- Cognitively impaired or unable to provide informed consent.
- Any other condition that, in the Investigator's opinion, may adversely affect the participant's ability to complete the study or its measures, or that may pose significant risk to the participant.
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
Alethios, Inc.
San Francisco, California, 94109
Alethios, 650-206-8006, support@alethios.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Investigate the Safety and Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants
The goal of this crossover clinical trial is to evaluate the efficacy and safety of Bloat Gummies on postprandial bloating and related gastrointestinal discomfort in healthy adults with recurrent bloating. The main question it aims to answer is whether Bloat gummies reduce post-meal bloating, gas, or abdominal pain (stomach) discomfort. Participants will be asked to consume one dose of Bloat or Placebo after 2 test meals and answer questionnaires on gas, bloating and abdominal distension.
- Conditions
- Digestive Health, Abdominal Discomfort, Gas and Bloating
- Being tested
- Bloat Gummies, Placebo
- Keywords
- bloating, abdominal distension, Arrae, intestinal gas
- Medical subject headings
- Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloat GummiesDietary supplement
Participants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart.
PlaceboDietary supplement
Participants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Bloat Gummy | Experimental | Bloat is a gummy that contains the active ingredients ginger root extract, lemon balm extract, dandelion root extract and the postbiotic HTES1, Bifidobacterium longum CECT7347. Receives: Dietary Supplement: Bloat Gummies |
| Placebo Gummy | Placebo comparator | The placebo is a gummy that looks and tastes like the study gummy, but with no active ingredients. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo.
Bloating severity assessed by Bloating Likert Scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."
Measured: Evaluated from pre-dose to 60 minutes post-dose
Secondary outcomes (5)
Mean change in bloating severity from pre-dose to t = 30 minutes post-dose, comparing active product vs placebo.
Bloating severity assessed by Bloating Likert Scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."
Measured: Evaluated from pre-dose to 30 minutes post-dose
Mean change in gas severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo.
Gas severity will be assessed by a Gas Likert scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."
Measured: Evaluated from pre-dose to 30 and 60 minutes post-dose.
Mean change in abdominal discomfort severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo.
Abdominal discomfort assessed by abdominal discomfort Likert Scale, of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."
Measured: Evaluated from pre-dose to 30 and 60 minutes post-dose.
Mean change in waist circumference from pre-dose to t = 30 and t = 60 minutes post-dose, comparing active product vs. placebo.
Abdominal distension assessed by mean change in waist circumference measurement.
Measured: Evaluated from pre-dose to 30 and 60 minutes post-dose.
Proportion of participants demonstrating a reduction in waist circumference.
Abdominal distension assessed by mean change in waist circumference measurement.
Measured: Evaluated at 30 minutes, 60 minutes or both timepoints post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive HealthStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrae
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516587
- Sponsor's protocol ID
- ARR001
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Investigate the Safety and Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants
- ClinicalTrials.gov ID
- NCT07516587
- Acronym / sponsor ID
- ARR001
- Conditions
- Digestive Health, Abdominal Discomfort, Gas and Bloating
- Keywords
- bloating, abdominal distension, Arrae, intestinal gas
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ArraeIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Apr 2026 (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.
The goal of this crossover clinical trial is to evaluate the efficacy and safety of Bloat Gummies on postprandial bloating and related gastrointestinal discomfort in healthy adults with recurrent bloating. The main question it aims to answer is whether Bloat gummies reduce post-meal bloating, gas, or abdominal pain (stomach) discomfort. Participants will be asked to consume one dose of Bloat or Placebo after 2 test meals and answer questionnaires on gas, bloating and abdominal distension.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bloat Gummy | Experimental | Dietary Supplement: Bloat GummiesBloat is a gummy that contains the active ingredients ginger root extract, lemon balm extract, dandelion root extract and the postbiotic HTES1, Bifidobacterium longum CECT7347. |
| Placebo Gummy | Placebo comparator | Dietary Supplement: PlaceboThe placebo is a gummy that looks and tastes like the study gummy, but with no active ingredients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy male and female individuals aged 18-65 years at time of screening.
- Body mass index (BMI) <29.9 kg/m².
- Self-reported recurrent postprandial abdominal bloating and/or distension occurring on average at least 2 days per week over the past 3 months, predominating over other gastrointestinal (GI) symptoms, and in the absence of a diagnosed gastrointestinal disease.
- Females of child-bearing potential must have a negative baseline pregnancy test and agree to use a medically approved method of birth control for the duration of the study.
- Willing to consume a standardized test meal consisting of 2 slices of large cheese pizza from Dominos on each test day.
Key exclusion criteria (13 listed)
- Current or past diagnosis of any significant disease of the GI tract, including but not limited to: irritable bowel syndrome (IBS), celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), functional constipation, gastroesophageal reflux disease (GERD), gastroparesis, or treatment for H. pylori infection or gastric ulcer within the past year.
- Significant or untreated medical and/or psychiatric disorders, including but not limited to: severe unstable diabetes, recent myocardial ischemia or infarction, unstable angina, cancer (except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative or volunteers with cancer in full remission for more than five years after diagnosis are acceptable), uncontrolled hypertension, renal failure, chronic active hepatitis, acute hepatitis, cirrhosis, Acquired Immunodeficiency Syndrome (AIDS), malignancy, and neurological disorders including epilepsy, recent cerebrovascular disease, or recent traumatic brain injury.
- Current use of digestive enzyme supplements, prebiotics/fibers, probiotics, postbiotics, bloating-targeted supplements, therapeutic iron supplementation (>65 mg elemental iron per dose), prokinetic agents, antacids, H2 blockers, proton pump inhibitors (PPIs), opioids, or loperamide within 14 days prior to the first test meal session; or use of any of the above during the study period.
- Esophageal obstruction or difficulty swallowing.
- Wear dentures.
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 |
|---|---|---|
| Bloat GummiesParticipants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart. | Dietary supplement | Bloat Gummy |
| PlaceboParticipants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart. | Dietary supplement | Placebo Gummy |
Primary outcome
Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo.
Time frame: Evaluated from pre-dose to 60 minutes post-dose
Bloating severity assessed by Bloating Likert Scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."
5 secondary outcomes
Mean change in bloating severity from pre-dose to t = 30 minutes post-dose, comparing active product vs placebo.
Time frame: Evaluated from pre-dose to 30 minutes post-dose
Mean change in gas severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo.
Time frame: Evaluated from pre-dose to 30 and 60 minutes post-dose.
Mean change in abdominal discomfort severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo.
Time frame: Evaluated from pre-dose to 30 and 60 minutes post-dose.
Mean change in waist circumference from pre-dose to t = 30 and t = 60 minutes post-dose, comparing active product vs. placebo.
Time frame: Evaluated from pre-dose to 30 and 60 minutes post-dose.
Proportion of participants demonstrating a reduction in waist circumference.
Time frame: Evaluated at 30 minutes, 60 minutes or both timepoints post-dose.
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 13 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloat Gummies in people with Digestive Health and Abdominal Discomfort, run by Arrae 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 13 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 13 Apr 2026. 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?
Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo. (time frame: Evaluated from pre-dose to 60 minutes post-dose). 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 13 Apr 2026.