Healthy ParticipantsNCT07163637
Effect of Limosilactobacillus Reuteri DSM 17648 in Healthy Adults Reporting Upper Gastrointestinal Discomfort
A study testing Limosilactobacillus reuteri DSM 17648 in people with Healthy Participants and Upper Gastrointestinal Discomfort, run by Novozymes A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Upper Gastrointestinal Discomfort
- What is being tested?
- Limosilactobacillus reuteri DSM 17648
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 27 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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:
- 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?
- Does L. reuteri DSM 17648 improve gastrointestinal-related quality of life, and perceived stress?
- How well do participants tolerate the L. reuteri DSM 17648 supplement?
- Does L. reuteri DSM 17648 have an effect on the gut microbiota? (Exploratory aim)
Read more
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
- Being tested
- Limosilactobacillus reuteri DSM 17648, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limosilactobacillus reuteri DSM 17648Dietary supplement
Also called Pylopass, PyloGuard
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.
PlaceboDietary supplement
One capsule of placebo should be taken once per day with liquid during or immediately after the main meal, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Limosilactobacillus reuteri DSM 17648 | Experimental | 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. Receives: Dietary Supplement: Limosilactobacillus reuteri DSM 17648 |
| Placebo | Placebo comparator | Participant will take one capsule of placebo once per day with liquid during or immediately after the main meal, for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 8 weeks
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start8 Sep 2025
- Primary completion27 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Swathi Varanasi, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163637
- Sponsor's protocol ID
- HHB-IM-24-07
- Status last verified
- Jun 2026
- First submitted
- 1 Sep 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07163637
- Acronym / sponsor ID
- HHB-IM-24-07
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Does L. reuteri DSM 17648 improve gastrointestinal-related quality of life, and perceived stress?
- How well do participants tolerate the L. reuteri DSM 17648 supplement?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limosilactobacillus reuteri DSM 17648 | Experimental | Dietary Supplement: Limosilactobacillus reuteri DSM 17648Participant will take one capsule of L. reuteri DSM 17648 once per day with liquid during or immediately after the main meal, for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipant will take one capsule of placebo once per day with liquid during or immediately after the main meal, for 8 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Anyone with an FSSG (Frequency Scale for the Symptoms of GERD) total score of 8 or above.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limosilactobacillus reuteri DSM 17648Also: Pylopass, PyloGuardOne capsule containing L. reuteri DSM 17648 should be taken once per day with liquid during or immediately after the main meal, for 8 weeks. | Dietary supplement | Limosilactobacillus reuteri DSM 17648 |
| PlaceboOne capsule of placebo should be taken once per day with liquid during or immediately after the main meal, for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 8 weeks
Time frame: Baseline; 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.
20 secondary outcomes
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 2 weeks
Time frame: Baseline, 2 weeks
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 4 weeks
Time frame: Baseline, 4 weeks
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 6 weeks
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
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
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
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
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
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
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
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
Time frame: Baseline, 8 weeks
Frequency Scale for the Symptoms of GERD (FSSG) relief rate at 4 weeks
Time frame: Baseline, Week 4
Frequency Scale for the Symptoms of GERD (FSSG) relief rate at 8 weeks
Time frame: Baseline, Week 8
Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 2 weeks
Time frame: Baseline, 2 weeks
Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 4 weeks
Time frame: Baseline, 4 weeks
Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 6 weeks
Time frame: Baseline, 6 weeks
Change from baseline quality of life, measured by Digestion-associated Quality of Life Questionnaire (DQLQ) at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline perceived stress, measured by Perceived Stress Scale, at 4 weeks
Time frame: Baseline, 4 weeks
Change from baseline perceived stress, measured by Perceived Stress Scale, at 8 weeks
Time frame: Baseline, 8 weeks
Number of participants with self-reported adverse events
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swathi Varanasi principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limosilactobacillus reuteri DSM 17648 in people with Healthy Participants and Upper Gastrointestinal Discomfort, run by Novozymes A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 8 weeks (time frame: Baseline; 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.