Limosilactobacillus reuteri DSM 17648 for upper stomach and reflux discomfort in adults
A Randomized, Double-Blind, Placebo-Controlled Decentralized Trial to Assess the Effect and Tolerability of Limosilactobacillus Reuteri DSM 17648 Supplement in Healthy Adults Reporting Upper Gastrointestinal Discomfort
This trial will test whether a daily inactivated L. reuteri DSM 17648 supplement can reduce heartburn, reflux, and other upper stomach discomfort in generally healthy adults aged 30–70.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Novozymes A/S Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Las Vegas, Nevada) |
| Trial ID | NCT07163637 on ClinicalTrials.gov |
What this trial studies
Adults who report occasional upper gastrointestinal discomfort will be assigned to take either a capsule containing inactivated L. reuteri DSM 17648 or a matching placebo every day for 8 weeks. Participants will complete symptom questionnaires (including the FSSG), quality-of-life and perceived-stress measures, and report any side effects to track tolerability. Investigators will compare symptom frequency, relief rates, and questionnaire scores between the supplement and placebo groups, and will perform an exploratory analysis of gut microbiota changes. The primary focus is symptom change over the 8-week intake period.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 30–70 with BMI ≤32 who experience upper gastrointestinal symptoms about twice weekly and have an FSSG score of 8 or higher.
Not a fit: People with uncontrolled chronic illnesses, recent serious medical events, substance abuse history, planned surgery during the study, or those outside the age/BMI limits may not benefit or be eligible for this supplement trial.
Why it matters
Potential benefit: If successful, the supplement could reduce the frequency and severity of reflux and dyspeptic symptoms and improve gastrointestinal-related quality of life for people with occasional upper GI discomfort.
How similar studies have performed: Some small clinical and product studies of related L. reuteri strains or postbiotic preparations have reported reductions in reflux or dyspeptic symptoms, but larger placebo‑controlled confirmations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be male or female. 2. Anyone with a BMI less than or equal to 32 kg/m². 3. Be aged 30-70. 4. Anyone currently experiencing occasional upper gastrointestinal discomfort (approximately 2 times/week over the past month), including the following: 1. Heartburn 2. Upper abdominal pain 3. Reflux 4. Pain or burning in the stomach 5. Anyone with an FSSG (Frequency Scale for the Symptoms of GERD) total score of 8 or above. 6. 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. 7. Willing to avoid introducing any new supplements, over-the-counter medications, or herbal remedies for the duration of this trial 8. 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. 9. Willing to maintain current diet, sleep pattern, and activity levels for the duration of the trial. 10. Resides in the United States. Exclusion Criteria: * 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.
Where this trial is running
Las Vegas, Nevada
- Citruslabs — Las Vegas, Nevada, United States (Recruiting)
Study contacts
- Principal investigator: Swathi Varanasi — Citruslabs
- Study coordinator: Director of Customer Success
- Email: jodi@citruslabs.com
- Phone: 805-285-3177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.