NCT07163637

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Novozymes A/S · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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. 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

Conditions

• Healthy Participants
• Upper Gastrointestinal Discomfort

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Limosilactobacillus reuteri DSM 17648	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.
DIETARY_SUPPLEMENT	Placebo	One capsule of placebo should be taken once per day with liquid during or immediately after the main meal, for 8 weeks.

Timeline

• Start date: 2025-09-08
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2025-09-09
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States