Digestive HealthNCT06516744
A Single Group Study to Evaluate the Efficacy of Bye Bye Bloat Capsules in Relieving Bloating and Promoting Healthy Digestion.
A study testing Bye Bye Bloat Capsules in people with Digestive Health and Digestion, run by Love Wellness at 1 site in United States.
Trial summary
This virtual single-group study aims to evaluate the efficacy of Bye Bye Bloat Capsules in relieving hormonal and food-related bloating and promoting healthy digestion. The study will last 4 weeks, involving 40 female participants aged 18+ who will take two capsules after meals and during times of bloating. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Digestive Health, Digestion
- What is being tested?
- Bye Bye Bloat Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 20 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18+
- Self-reported concerns with bloating after eating
- Issues with hormonal bloating
- Generally healthy without uncontrolled chronic diseases
- Willing to avoid using digestive health remedies and other oral supplements during the study
Who cannot join
- Pre-existing chronic conditions preventing adherence to the protocol
- Undergoing procedures related to digestive health
- Started new medications or supplements targeting digestive health in the past 3 months
- Severe allergic reactions requiring an Epi-Pen
- Pregnant, breastfeeding, or attempting to conceive
- Unwilling to follow the study protocol
Show all 9Show fewer
- Recent surgeries or planned surgeries during the study
- Diagnosed gastrointestinal disorders
- Recent changes in hormonal birth control use
Trial locations and contacts
1 site in 1 country.
About this study
This virtual single-group study aims to evaluate the efficacy of Bye Bye Bloat Capsules in relieving hormonal and food-related bloating and promoting healthy digestion. The study will last 4 weeks, involving 40 female participants aged 18+ who will take two capsules after meals and during times of bloating. Measurements and questionnaires will be completed at Baseline, first use, Week 2, and Week 4.
- Conditions
- Digestive Health, Digestion
- Being tested
- Bye Bye Bloat Capsules
- Keywords
- Gastrointestinal Symptoms, Hormonal Bloating, Capsule Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bye Bye Bloat CapsulesDietary supplement
Bye Bye Bloat Capsules contain the following ingredients: Organic Fenugreek Seed Powder, Organic Dandelion Root Powder, Organic Fennel Seed Powder, Organic Ginger Root Powder, Organic Parsley Leaf Powder, Amylase Complex, Protease Complex, Pepsin Complex, Lipase Complex, Bromelain Complex, Papain Complex. Other ingredients include Hypromellose Capsule, Maltodextrin, Microcrystalline Cellulose, and Magnesium Stearate. Participants will take 2 capsules immediately after eating at least 3 times a week and during times of hormonal bloating for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bye Bye Bloat Capsules | Experimental | Participants will take 2 Bye Bye Bloat capsules immediately after eating (when they feel full and bloated) at least 3 times a week. They may also take the product during times of hormonal bloating. The study will last for 4 weeks, with questionnaires and waist measurements completed at Baseline, first use, Week 2, and Week 4. Receives: Dietary Supplement: Bye Bye Bloat Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Bloating
Evaluation of parameters associated with hormonal and food-related bloating through self-reported questionnaires taken at Baseline, first use, Week 2, and Week 4.
Measured: Baseline, first use, Week 2, and Week 4
Secondary outcomes (1)
Improvement in Digestion and Mental Well-being
Assessment of changes in participant perception of digestion, gas, mental health, and well-being associated with bloating through self-reported questionnaires taken at Baseline, first use, Week 2, and Week 4.
Measured: Baseline, first use, Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start8 Feb 2024
- Primary completion20 Apr 2024
- Study completion20 Apr 2024
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Love Wellness
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516744
- Sponsor's protocol ID
- 20402
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 24 Jul 2024
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Study to Evaluate the Efficacy of Bye Bye Bloat Capsules in Relieving Bloating and Promoting Healthy Digestion.
- ClinicalTrials.gov ID
- NCT06516744
- Acronym / sponsor ID
- 20402
- Conditions
- Digestive Health, Digestion
- Keywords
- Gastrointestinal Symptoms, Hormonal Bloating, Capsule Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Love WellnessIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 24 Jul 2024 (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 virtual single-group study aims to evaluate the efficacy of Bye Bye Bloat Capsules in relieving hormonal and food-related bloating and promoting healthy digestion. The study will last 4 weeks, involving 40 female participants aged 18+ who will take two capsules after meals and during times of bloating. Measurements and questionnaires will be completed at Baseline, first use, Week 2, and Week 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bye Bye Bloat Capsules | Experimental | Dietary Supplement: Bye Bye Bloat CapsulesParticipants will take 2 Bye Bye Bloat capsules immediately after eating (when they feel full and bloated) at least 3 times a week. They may also take the product during times of hormonal bloating. The study will last for 4 weeks, with questionnaires and waist measurements completed at Baseline, first use, Week 2, and Week 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18+
- Self-reported concerns with bloating after eating
- Issues with hormonal bloating
- Generally healthy without uncontrolled chronic diseases
- Willing to avoid using digestive health remedies and other oral supplements during the study
Key exclusion criteria (9 listed)
- Pre-existing chronic conditions preventing adherence to the protocol
- Undergoing procedures related to digestive health
- Started new medications or supplements targeting digestive health in the past 3 months
- Severe allergic reactions requiring an Epi-Pen
- Pregnant, breastfeeding, or attempting to conceive
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 |
|---|---|---|
| Bye Bye Bloat CapsulesBye Bye Bloat Capsules contain the following ingredients: Organic Fenugreek Seed Powder, Organic Dandelion Root Powder, Organic Fennel Seed Powder, Organic Ginger Root Powder, Organic Parsley Leaf Powder, Amylase Complex, Protease Complex, Pepsin Complex, Lipase Complex, Bromelain Complex, Papain Complex. Other ingredients include Hypromellose Capsule, Maltodextrin, Microcrystalline Cellulose, and Magnesium Stearate. Participants will take 2 capsules immediately after eating at least 3 times a week and during times of hormonal bloating for 4 weeks. | Dietary supplement | Bye Bye Bloat Capsules |
Primary outcome
Reduction in Bloating
Time frame: Baseline, first use, Week 2, and Week 4
Evaluation of parameters associated with hormonal and food-related bloating through self-reported questionnaires taken at Baseline, first use, Week 2, and Week 4.
1 secondary outcome
Improvement in Digestion and Mental Well-being
Time frame: Baseline, first use, Week 2, and Week 4
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 24 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Digestive Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
Active, not recruiting
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Colorectal Cancer
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
RecruitingObservational study
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Cancer, Cancer Diagnosis
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 Bye Bye Bloat Capsules in people with Digestive Health and Digestion, run by Love Wellness 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 9 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 24 Jul 2024. 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?
Reduction in Bloating (time frame: Baseline, first use, Week 2, and Week 4). 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 Jul 2024.