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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Novozymes A/S
Study ID
NCT07163637
Status
Recruiting
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Conditions

  • Healthy Participants
  • Upper Gastrointestinal Discomfort

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Sep 8, 2025
Status verified
Sep 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Limosilactobacillus reuteri DSM 17648
    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.
  • Placebo Comparator: Placebo
    Participant will take one capsule of placebo once per day with liquid during or immediately after the main meal, for 8 weeks.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CitruslabsLas VegasNevada89118
Director of Customer Success
[email protected]
805-285-3177

Find similar trials in Las Vegas, NV

By research site
Citruslabs· Las Vegas, NV

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