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

NCT07163637 | Recruiting

• 1 other identifier: HHB-IM-24-07
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Healthy Participants; Upper Gastrointestinal Discomfort

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline, 2 weeks

• Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 4 weeks

  Baseline, 4 weeks

• Change from Baseline in the total score of Frequency Scale for the Symptoms of GERD (FSSG) at 6 weeks

  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

  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

  Baseline, 4 weeks

Other Outcomes (1)

• Change from baseline microbiome profile in fecal samples at 8 weeks

  Baseline, 8 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Limosilactobacillus reuteri DSM 17648 DIETARY_SUPPLEMENT

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

Limosilactobacillus reuteri DSM 17648

Placebo DIETARY_SUPPLEMENT

One capsule of placebo should be taken once per day with liquid during or immediately after the main meal, for 8 weeks.

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• \. Anyone with any allergies or sensitivities to any of the study product ingredients.
• \. Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
• \. Anyone unwilling to follow the study protocol. 4. Anyone taking any supplement, over-the-counter medication, or herbal remedy targeting gut health.
• \. 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.
• \. Anyone currently or recently (within the past 2 weeks) taking probiotic foods, including yoghurts.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Novozymes A/S: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

RECRUITING

Study Officials

• Swathi Varanasi

  Citruslabs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Director of Customer Success

CONTACT

805-285-3177; jodi@citruslabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 8, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)