Actively Recruiting

Phase Not Applicable
Age: 30Years - 70Years
All Genders
Healthy Volunteers
NCT07163637

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

Led by Novozymes A/S · Updated on 2025-09-22

324

Participants Needed

1

Research Sites

29 weeks

Total Duration

On this page

Sponsors

N

Novozymes A/S

Lead Sponsor

C

Citruslabs

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be male or female.
  • Have a BMI less than or equal to 32 kg/m8.
  • Be aged 30 to 70 years.
  • Currently experience occasional upper gastrointestinal discomfort about 2 times per week over the past month, including heartburn, upper abdominal pain, reflux, or stomach pain/burning.
  • Have a Frequency Scale for the Symptoms of GERD (FSSG) total score of 8 or above.
  • Be generally healthy without uncontrolled chronic health conditions, serious recent illness, substance abuse history, or planned surgery during the study.
  • Willing to avoid new supplements, over-the-counter medications, or herbal remedies during the trial.
  • If taking other supplements or medications unrelated to gut health, have been doing so consistently for at least 3 months.
  • Willing to maintain current diet, sleep, and activity levels during the trial.
  • Reside in the United States.
Not Eligible

You will not qualify if you...

  • Have allergies or sensitivities to any ingredients in the study products.
  • Are pregnant, breastfeeding, or trying to conceive during the study period.
  • Are unwilling to follow the study protocol.
  • Are taking any supplement, over-the-counter medication, or herbal remedy targeting gut health.
  • Have a history of severe digestive disorders such as GERD, functional dyspepsia, IBS, IBD, Crohn's disease, celiac disease, chronic constipation or diarrhea, or gastrointestinal surgeries.
  • Have taken probiotic foods like yoghurts within the past 2 weeks.
  • Have taken certain medications within the past 12 weeks, including proton pump inhibitors, anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, corticosteroids over 5 mg/day, diabetic medications, oral anti-infectives, antipsychotics, MAOIs, or thyroid products.
  • Are currently participating or plan to participate in another research study during the 8-week trial period.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Citruslabs

Las Vegas, Nevada, United States, 89118

Actively Recruiting

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Research Team

D

Director of Customer Success

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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