Gastrointestinal DiscomfortNCT07898189
A Study to Evaluate the Effects of a Supplement on Gut Comfort in GLP-1 Receptor Agonist Users
A study testing Oxxynea® Supplement in people with Gastrointestinal Discomfort and Gastrointestinal Side Effects of GLP-1 Receptor Agonist Use, run by AB Mauri (UK) Limited, at 1 site in United States.
Trial summary
This is a randomized, triple-blind, placebo-controlled, virtual clinical trial evaluating the effects of the Oxxynea® botanical supplement on gut comfort in adults who use GLP-1 receptor agonists (GLP-1 RAs). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastrointestinal Discomfort, Gastrointestinal Side Effects of GLP-1 Receptor Agonist Use, Nausea
- What is being tested?
- Oxxynea® Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Oct 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be male or female.
- Be aged 18-65.
- BMI ≥ 27.
- Anyone currently taking a GLP-1-based therapy, including GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists.
- Anyone experiencing issues regarding at least two of the following symptoms since starting a GLP-1 receptor agonist medication, at a frequency of at least 2-3 times per week: gut discomfort, diarrhea, abdominal pain/cramping, bloating, or nausea.
- Self-reported low fruit and vegetable intake (less than 2 pieces per day).
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- Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- If taking oral over-the-counter supplements or herbal remedies targeted at gut comfort, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration.
- Resides in the United States.
- Anyone who is willing to follow the study protocol.
- Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial.
Who cannot join
- Anyone with chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Use of antibiotics in the last 15 days.
- Anyone planning on introducing any products or any new forms of prescription medication or supplements that target gut comfort for the study duration.
- Anyone with a known history of severe digestive disorders like acid reflux, celiac disease, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), ulcerative colitis, Crohn's disease, or gastrointestinal tract surgeries.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
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- Anyone taking anticoagulants ('blood thinners') or who has been diagnosed with a bleeding disorder.
- Anyone who takes medications that may interact with botanical supplements, including but not limited to antihypertensives, blood glucose-lowering agents, anticoagulants/antiplatelet therapies, or medications known to interact with grapefruit.
- Anyone who has a history of serious illness in the last three months.
- Anyone who has planned surgery during the study period.
- Anyone with a history of substance abuse.
- Anyone who is a heavy drinker (i.e., a woman who drinks eight or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week).
- Anyone who is currently a smoker or has been a smoker in the past 3 months.
- Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration.
- Anyone with a chronic hepatic or renal disease.
- Anyone with a known sulphite sensitivity.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, triple-blind, placebo-controlled, virtual clinical trial evaluating the effects of the Oxxynea® botanical supplement on gut comfort in adults who use GLP-1 receptor agonists (GLP-1 RAs). Seventy participants experiencing gastrointestinal discomfort associated with GLP-1 RA use will be randomized to receive either Oxxynea® or a matching placebo once daily for six weeks.
Participants will complete questionnaires at Baseline, daily for the first 14 days, and at the end of Weeks 2, 4, and 6. The primary measure is change in gastrointestinal comfort assessed by the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures include quality of life, participant-perceived product benefits, and specific GI symptom changes (nausea, abdominal pain, bloating, diarrhea, and constipation).
- Conditions
- Gastrointestinal Discomfort, Gastrointestinal Side Effects of GLP-1 Receptor Agonist Use, Nausea, Abdominal Pain, Bloating, Diarrhea
- Being tested
- Placebo, Oxxynea® Supplement
- Medical subject headings
- Nausea, Abdominal Pain, Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Participants take one capsule of a matching placebo (maltodextrin 400 mg in a transparent green HPMC capsule, size 0) once daily in the morning with the first meal of the day for six weeks. The placebo is matched to the active product in taste and appearance.
Oxxynea® SupplementDietary supplement
Participants take one capsule of Oxxynea® once daily in the morning with the first meal of the day for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Oxxynea® Supplement | Experimental | Not described Receives: Dietary Supplement: Oxxynea® Supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Comfort and Gut Health
Mean change in the GI symptom subscale of the Gastrointestinal Quality of Life Index (GIQLI) score from Baseline
Measured: Baseline, Week 2, Week 4, and Week 6
Secondary outcomes (9)
Change in Physical Functioning
Mean change in the GIQLI items corresponding to Physical Functioning (part of the 16-item Physical Functioning, Emotional Well-being, and Social Functioning subscale) from Baseline
Measured: Baseline, Week 2, Week 4, and Week 6
Change in Emotional Well-being
Mean change in the GIQLI items corresponding to Emotional Well-being (part of the 16-item Physical Functioning, Emotional Well-being, and Social Functioning subscale) from Baseline
Measured: Baseline, Week 2, Week 4, and Week 6
Change in Social Functioning
Mean change in the GIQLI items corresponding to Social Functioning (part of the 16-item Physical Functioning, Emotional Well-being, and Social Functioning subscale) from Baseline
Measured: Baseline, Week 2, Week 4, and Week 6
Change in Participant-Perceived Effects of Medical Treatment
Mean change in the GIQLI item corresponding to Effects of Medical Treatment from Baseline
Measured: Baseline, Week 2, Week 4, and Week 6
Change in Nausea
Mean change in the GIQLI nausea item score, assessed via an adapted version of the GIQLI questionnaire
Measured: Daily for Days 1-14
Change in Abdominal Pain
Mean change in the GIQLI abdominal pain item score, assessed via an adapted version of the GIQLI questionnaire
Measured: Daily for Days 1-14
Change in Bloating
Mean change in the GIQLI bloating item score, assessed via an adapted version of the GIQLI questionnaire
Measured: Daily for Days 1-14
Change in Diarrhea
Mean change in the GIQLI diarrhea item score, assessed via an adapted version of the GIQLI questionnaire
Measured: Daily for Days 1-14
Change in Constipation
Mean change in the GIQLI constipation item score, assessed via an adapted version of the GIQLI questionnaire
Measured: Daily for Days 1-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiscomfortStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Mauri (UK) Limited,
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898189
- Sponsor's protocol ID
- #ABBIO-24994
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of a Supplement on Gut Comfort in GLP-1 Receptor Agonist Users
- ClinicalTrials.gov ID
- NCT07898189
- Acronym / sponsor ID
- #ABBIO-24994
- Conditions
- Gastrointestinal Discomfort, Gastrointestinal Side Effects of GLP-1 Receptor Agonist Use, Nausea, Abdominal Pain, Bloating, Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AB Mauri (UK) Limited,Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 27 Oct 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.
This is a randomized, triple-blind, placebo-controlled, virtual clinical trial evaluating the effects of the Oxxynea® botanical supplement on gut comfort in adults who use GLP-1 receptor agonists (GLP-1 RAs). Seventy participants experiencing gastrointestinal discomfort associated with GLP-1 RA use will be randomized to receive either Oxxynea® or a matching placebo once daily for six weeks.
Participants will complete questionnaires at Baseline, daily for the first 14 days, and at the end of Weeks 2, 4, and 6. The primary measure is change in gastrointestinal comfort assessed by the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures include quality of life, participant-perceived product benefits, and specific GI symptom changes (nausea, abdominal pain, bloating, diarrhea, and constipation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxxynea® Supplement | Experimental | Dietary Supplement: Oxxynea® Supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be male or female.
- Be aged 18-65.
- BMI ≥ 27.
- Anyone currently taking a GLP-1-based therapy, including GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists.
- Anyone experiencing issues regarding at least two of the following symptoms since starting a GLP-1 receptor agonist medication, at a frequency of at least 2-3 times per week: gut discomfort, diarrhea, abdominal pain/cramping, bloating, or nausea.
Key exclusion criteria (16 listed)
- Anyone with chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Use of antibiotics in the last 15 days.
- Anyone planning on introducing any products or any new forms of prescription medication or supplements that target gut comfort for the study duration.
- Anyone with a known history of severe digestive disorders like acid reflux, celiac disease, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), ulcerative colitis, Crohn's disease, or gastrointestinal tract surgeries.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
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 |
|---|---|---|
| PlaceboParticipants take one capsule of a matching placebo (maltodextrin 400 mg in a transparent green HPMC capsule, size 0) once daily in the morning with the first meal of the day for six weeks. The placebo is matched to the active product in taste and appearance. | Dietary supplement | Placebo |
| Oxxynea® SupplementParticipants take one capsule of Oxxynea® once daily in the morning with the first meal of the day for six weeks. | Dietary supplement | Oxxynea® Supplement |
Primary outcome
Change in Gastrointestinal Comfort and Gut Health
Time frame: Baseline, Week 2, Week 4, and Week 6
Mean change in the GI symptom subscale of the Gastrointestinal Quality of Life Index (GIQLI) score from Baseline
9 secondary outcomes
Change in Physical Functioning
Time frame: Baseline, Week 2, Week 4, and Week 6
Change in Emotional Well-being
Time frame: Baseline, Week 2, Week 4, and Week 6
Change in Social Functioning
Time frame: Baseline, Week 2, Week 4, and Week 6
Change in Participant-Perceived Effects of Medical Treatment
Time frame: Baseline, Week 2, Week 4, and Week 6
Change in Nausea
Time frame: Daily for Days 1-14
Change in Abdominal Pain
Time frame: Daily for Days 1-14
Change in Bloating
Time frame: Daily for Days 1-14
Change in Diarrhea
Time frame: Daily for Days 1-14
Change in Constipation
Time frame: Daily for Days 1-14
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 27 Oct 2026.
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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 Oxxynea® Supplement in people with Gastrointestinal Discomfort and Gastrointestinal Side Effects of GLP-1 Receptor Agonist Use, run by AB Mauri (UK) Limited, 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 11 inclusion and 16 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 27 Oct 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?
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 Gastrointestinal Comfort and Gut Health (time frame: Baseline, Week 2, Week 4, and Week 6). 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 27 Oct 2026.