An interventional study of Limosilactobacillus reuteri DSM 17648 and Placebo in Healthy Participants and Upper Gastrointestinal Discomfort, sponsored by Novozymes A/S. Completed at 1 site in United States. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Novozymes A/S · Not applicable, Interventional, and Treatment
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:
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:
Novozymes A/S is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Anyone currently experiencing occasional upper gastrointestinal discomfort (approximately 2 times/week over the past month), including the following:
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.
Participant will take one capsule of L. reuteri DSM 17648 once per day with liquid during or immediately after the main meal, for 8 weeks.
Dietary Supplement: Limosilactobacillus reuteri DSM 17648
Participant will take one capsule of placebo once per day with liquid during or immediately after the main meal, for 8 weeks.
Dietary Supplement: Placebo
One capsule containing L. reuteri DSM 17648 should be taken once per day with liquid during or immediately after the main meal, for 8 weeks.
Also known as: Pylopass, PyloGuard
One capsule of placebo should be taken once per day with liquid during or immediately after the main meal, for 8 weeks.
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 8 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG questionnaire comprises twelve questions in two domains, i.e. the acid reflux related symptom domain and dyspeptic symptom domain. The FSSG uses a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. Total FSSG score ranges from 0-48. Higher score indicates higher frequency.
Time frame: Baseline; 8 weeks
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 2 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG questionnaire comprises twelve questions in two domains, i.e. the acid reflux related symptom domain and dyspeptic symptom domain. The FSSG uses a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. Total FSSG score ranges from 0-48. Higher score indicates higher frequency.
Time frame: Baseline, 2 weeks
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 4 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG questionnaire comprises twelve questions in two domains, i.e. the acid reflux related symptom domain and dyspeptic symptom domain. The FSSG uses a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. Total FSSG score ranges from 0-48. Higher score indicates higher frequency.
Time frame: Baseline, 4 weeks
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 6 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG questionnaire comprises twelve questions in two domains, i.e. the acid reflux related symptom domain and dyspeptic symptom domain. The FSSG uses a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. Total FSSG score ranges from 0-48. Higher score indicates higher frequency.
Time frame: Baseline, 6 weeks
Change from Baseline in the acid reflux related symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 2 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG acid reflux related symptom sub-score domain comprises 7 questions, with answers in a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. FSSG acid reflux related symptom score ranges from 0-28. Higher score indicates higher frequency.
Time frame: Baseline, 2 weeks
Change from Baseline in the acid reflux related symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 4 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG acid reflux related symptom sub-score domain comprises 7 questions, with answers in a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. FSSG acid reflux related symptom score ranges from 0-28. Higher score indicates higher frequency.
Time frame: Baseline, 4 weeks
Change from Baseline in the acid reflux related symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 6 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG acid reflux related symptom sub-score domain comprises 7 questions, with answers in a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. FSSG acid reflux related symptom score ranges from 0-28. Higher score indicates higher frequency.
Time frame: Baseline, 6 weeks
Change from Baseline in the acid reflux related symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 8 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG acid reflux related symptom sub-score domain comprises 7 questions, with answers in a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. FSSG acid reflux related symptom score ranges from 0-28. Higher score indicates higher frequency.
Time frame: Baseline, 8 weeks
Change from Baseline in the dyspeptic symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 2 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG dyspeptic symptom sub-score domain comprises 5 questions, with answers in a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. FSSG dyspeptic symptom score ranges from 0-20. Higher score indicates higher frequency.
Time frame: Baseline, 2 weeks
Change from Baseline in the dyspeptic symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 4 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG dyspeptic symptom sub-score domain comprises 5 questions, with answers in a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. FSSG dyspeptic symptom score ranges from 0-20. Higher score indicates higher frequency.
Time frame: Baseline, 4 weeks
Change from Baseline in the dyspeptic symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 6 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG dyspeptic symptom sub-score domain comprises 5 questions, with answers in a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. FSSG dyspeptic symptom score ranges from 0-20. Higher score indicates higher frequency.
Time frame: Baseline, 6 weeks
Change from Baseline in the dyspeptic symptom sub-score of Frequency Scale for the Symptoms of GERD (FSSG) at 8 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The FSSG dyspeptic symptom sub-score domain comprises 5 questions, with answers in a 5-point Likert scale (0-4) for each question, where: never = 0; occasionally = 1; sometimes = 2; often = 3; and always = 4. FSSG dyspeptic symptom score ranges from 0-20. Higher score indicates higher frequency.
Time frame: Baseline, 8 weeks
Frequency Scale for the Symptoms of GERD (FSSG) relief rate at 4 weeks
Relief rate is the number of participants whose symptoms were alleviated (lower score) at 4 weeks compared to Baseline based on the changes in FSSG scores.
Time frame: Baseline, Week 4
Frequency Scale for the Symptoms of GERD (FSSG) relief rate at 8 weeks
Relief rate is the number of participants whose symptoms were alleviated (lower score) at 8 weeks compared to Baseline based on the changes in FSSG scores.
Time frame: Baseline, Week 8
Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 2 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. DQLQ includes 9 statements that assess how often digestive events and experiences affected the quality of life over the past 7 days, with each scored on a 7-point Likert scale (Never = 0, Rarely = 0.1, Occasionally = 0.3, Sometimes = 0.5, Frequently = 0.7, Usually = 0.9, Always = 1.0). The total score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life.
Time frame: Baseline, 2 weeks
Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 4 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. DQLQ includes 9 statements that assess how often digestive events and experiences affected the quality of life over the past 7 days, with each scored on a 7-point Likert scale (Never = 0, Rarely = 0.1, Occasionally = 0.3, Sometimes = 0.5, Frequently = 0.7, Usually = 0.9, Always = 1.0). The total score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life.
Time frame: Baseline, 4 weeks
Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 6 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. DQLQ includes 9 statements that assess how often digestive events and experiences affected the quality of life over the past 7 days, with each scored on a 7-point Likert scale (Never = 0, Rarely = 0.1, Occasionally = 0.3, Sometimes = 0.5, Frequently = 0.7, Usually = 0.9, Always = 1.0). The total score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life.
Time frame: Baseline, 6 weeks
Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 8 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. DQLQ includes 9 statements that assess how often digestive events and experiences affected the quality of life over the past 7 days, with each scored on a 7-point Likert scale (Never = 0, Rarely = 0.1, Occasionally = 0.3, Sometimes = 0.5, Frequently = 0.7, Usually = 0.9, Always = 1.0). The total score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life.
Time frame: Baseline, 8 weeks
Change from baseline perceived stress, measured by Perceived Stress Scale, at 4 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The 10-item Perceived Stress Scale (PSS-10) uses a 5-point Likert scale ranging from 0 (Never) to 4 (Very Often), with some items (positive worded items) reverse-scored to balance the scale. Total scores range from 0 to 40, with higher scores indicating higher levels of stress.
Time frame: Baseline, 4 weeks
Change from baseline perceived stress, measured by Perceived Stress Scale, at 8 weeks
Difference between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared. The 10-item Perceived Stress Scale (PSS-10) uses a 5-point Likert scale ranging from 0 (Never) to 4 (Very Often), with some items (positive worded items) reverse-scored to balance the scale. Total scores range from 0 to 40, with higher scores indicating higher levels of stress.
Time frame: Baseline, 8 weeks
Number of participants with self-reported adverse events
Number of participants with self-reported adverse events will be collected and summarized descriptively at each time point for both the Limosilactobacillus reuteri DSM 17648 and placebo groups.
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Change from baseline microbiome profile in fecal samples at 8 weeks
Difference in microbial diversity of fecal samples between Limosilactobacillus reuteri DSM 17648 and placebo arm will be compared.
Time frame: Baseline, 8 weeks
Plan to share: No
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Novozymes A/S