Status:
RECRUITING
Effect of Limosilactobacillus Reuteri DSM 17648 in Healthy Adults Reporting Upper Gastrointestinal Discomfort
Lead Sponsor:
Novozymes A/S
Collaborating Sponsors:
Citruslabs
Conditions:
Healthy Participants
Upper Gastrointestinal Discomfort
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if the food supplement containing a postbiotic (inanimate) Limosilactobacillus reuteri DSM 17648 works to improve the symptoms of upper gastrointestinal dis...
Eligibility Criteria
Inclusion
- Be male or female.
- Anyone with a BMI less than or equal to 32 kg/m².
- Be aged 30-70.
- Anyone currently experiencing occasional upper gastrointestinal discomfort (approximately 2 times/week over the past month), including the following:
- Heartburn
- Upper abdominal pain
- Reflux
- Pain or burning in the stomach
- Anyone with an FSSG (Frequency Scale for the Symptoms of GERD) total score of 8 or above.
- Anyone who is generally healthy - does not live with any uncontrolled chronic health conditions, such as cancer, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
- Willing to avoid introducing any new supplements, over-the-counter medications, or herbal remedies for the duration of this trial
- If taking other supplements, over-the-counter medications, or herbal remedies unrelated to gut health, has been doing so consistently for a minimum of three months.
- Willing to maintain current diet, sleep pattern, and activity levels for the duration of the trial.
- Resides in the United States.
Exclusion
- 1\. Anyone with any allergies or sensitivities to any of the study product ingredients.
- 2\. Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- 3\. Anyone unwilling to follow the study protocol. 4. Anyone taking any supplement, over-the-counter medication, or herbal remedy targeting gut health.
- 5\. Anyone with a known history of severe digestive disorders like GERD (Gastroesophageal Reflux Disease) and FD (Functional Dyspepsia), Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, celiac disease, chronic constipation, chronic diarrhea, or gastrointestinal tract disorders or surgeries.
- 6\. Anyone currently or recently (within the past 2 weeks) taking probiotic foods, including yoghurts.
- 7\. Anyone currently or recently (within the last 12 weeks) taking medication, including proton pump inhibitors, anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, monoamine oxidase inhibitors (MAOIs), or thyroid products.
- 8\. Currently partaking in another research study or will partake in any other research study for the next eight weeks or at any point during this study's duration.
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT07163637
Start Date
September 8 2025
End Date
March 31 2026
Last Update
September 22 2025
Active Locations (1)
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1
Citruslabs
Las Vegas, Nevada, United States, 89118