RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-09-08
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07163637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be male or female.
  2. 2. Anyone with a BMI less than or equal to 32 kg/m².
  3. 3. Be aged 30-70.
  4. 4. Anyone currently experiencing occasional upper gastrointestinal discomfort (approximately 2 times/week over the past month), including the following:
  5. 1. Heartburn
  6. 2. Upper abdominal pain
  7. 3. Reflux
  8. 4. Pain or burning in the stomach
  9. 5. Anyone with an FSSG (Frequency Scale for the Symptoms of GERD) total score of 8 or above.
  10. 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.
  11. 7. Willing to avoid introducing any new supplements, over-the-counter medications, or herbal remedies for the duration of this trial
  12. 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 months.
  13. 9. Willing to maintain current diet, sleep pattern, and activity levels for the duration of the trial.
  14. 10. Resides in the United States.
  1. * 1\. Anyone with any allergies or sensitivities to any of the study product ingredients.

Contacts and Locations

Study Contact

Director of Customer Success
CONTACT
805-285-3177
jodi@citruslabs.com

Principal Investigator

Swathi Varanasi
PRINCIPAL_INVESTIGATOR
Citruslabs

Study Locations (Sites)

Citruslabs
Las Vegas, Nevada, 89118
United States

Collaborators and Investigators

Sponsor: Novozymes A/S

  • Swathi Varanasi, PRINCIPAL_INVESTIGATOR, Citruslabs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-08
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2025-09-08
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy Participants
  • Upper Gastrointestinal Discomfort