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Recruiting NCT07163637

Effect of Limosilactobacillus Reuteri DSM 17648 in Healthy Adults Reporting Upper Gastrointestinal Discomfort

Trial Parameters

Condition Healthy Participants
Sponsor Novozymes A/S
Study Type INTERVENTIONAL
Phase N/A
Enrollment 324
Sex ALL
Min Age 30 Years
Max Age 70 Years
Start Date 2025-09-08
Completion 2026-03-31
Interventions
Limosilactobacillus reuteri DSM 17648Placebo

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 discomfort in healthy adults. The main questions it aims to answer are: 1. Does L. reuteri DSM 17648 reduce the frequency of the symptoms of upper gastrointestinal discomfort, including acid reflux-related and dyspeptic symptoms, and its relief rate, over 8 weeks of intake? 2. Does L. reuteri DSM 17648 improve gastrointestinal-related quality of life, and perceived stress? 3. How well do participants tolerate the L. reuteri DSM 17648 supplement? 4. Does L. reuteri DSM 17648 have an effect on the gut microbiota? (Exploratory aim) Researchers will compare supplement containing L. reuteri DSM 17648 to a placebo (a look-alike supplement capsule that contains no L. reuteri DSM 17648). Participants will: * Take L. reuteri DSM 17648 supplement or a placebo every day for 8 weeks * Answer questionnaires once every 2 weeks * Provide stool samples for microbiome assessment at 2 timepoints (baseline and end of study (8 weeks)) * provide weekly information on investigational product intake and any adverse event records

Eligibility 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 m

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