MedTrace Logo

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

NCT07163637 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-09-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Citruslabs

    collaborator INDUSTRY

  • Novozymes A/S

    lead INDUSTRY

Principal Investigators

  • Swathi Varanasi · Citruslabs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07163637 on ClinicalTrials.gov