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NCT07163637 · ClinicalTrials.gov registry record · NA

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

A NA study of Healthy Participants and Upper Gastrointestinal Discomfort, sponsored by Novozymes A/S.

Recruiting
Registry status
NA
Development phase
324
Enrollment target
1
Study location

NCT07163637: Recruiting NA study of Healthy Participants and Upper Gastrointestinal Discomfort, sponsored by Novozymes A/S.

NCT07163637 is a NA study of Healthy Participants and Upper Gastrointestinal Discomfort that is actively recruiting participants, run by Novozymes A/S. The registered enrollment target is 324 participants, above the 63-participant average among 119 other Healthy Participants trials with a reported enrollment target (414% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07163637, a NA study of Healthy Participants and Upper Gastrointestinal Discomfort, is actively recruiting participants, sponsored by Novozymes A/S.

RECRUITING
Registry status
NA
Development phase
324 participants
Enrollment target
1
Study location

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

Primary Outcome

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.

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT Limosilactobacillus reuteri DSM 17648

Study Locations (1)

Nevada

  • Citruslabs - Las Vegas

Trial Details

FieldValue
Enrollment Target 324 participants
Start Date 2025-09-08
Est. Completion 2026-03-31
Phase NA
Novozymes A/S

5 total trials

What NCT07163637 shows while recruiting

NCT07163637 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, above the 63-participant average among 119 other Healthy Participants trials with a reported enrollment target (414% higher).

The record links to 2 conditions, with Healthy Participants appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07163637 reports a single indexed study location in Nevada.

Frequently Asked Questions

What is clinical trial NCT07163637 about?

NCT07163637 is a clinical study titled "Effect of Limosilactobacillus Reuteri DSM 17648 in Healthy Adults Reporting Upper Gastrointestinal Discomfort". 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 r...

What is the current status of trial NCT07163637?

This trial is currently recruiting. It is a NA study. The enrollment target is 324 participants. The study started on 2025-09-08. Estimated completion is 2026-03-31.

What conditions does trial NCT07163637 study?

This clinical trial studies the following conditions: Healthy Participants, Upper Gastrointestinal Discomfort.

What interventions are being tested in trial NCT07163637?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Limosilactobacillus reuteri DSM 17648 (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT07163637?

This trial is sponsored by Novozymes A/S, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07163637 being conducted?

This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy Participants

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07163637's enrollment target sits among peer trials

324 3rd of 119 higher than 117 of 119 other Healthy Participants trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy Participants trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07163637, the US trial registry maintained by the National Library of Medicine. NCT07163637 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.