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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
324
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.
One capsule of placebo should be taken once per day with liquid during or immediately after the main meal, for 8 weeks.
Citruslabs
Las Vegas, Nevada, United States
RECRUITINGChange 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
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