Limosilactobacillus Reuteri for Indigestion

Overseen By Jodi Director of Customer Success

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Novozymes A/S

Must not be taking: Probiotics, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Severe digestive disorders, others

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

324 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a food supplement containing Limosilactobacillus reuteri (a probiotic) can reduce symptoms such as heartburn and upper abdominal pain in individuals who often experience upper gastrointestinal discomfort. Participants will take either the supplement or a placebo daily for eight weeks and report on their symptoms, stress levels, and gut health. Individuals who frequently experience symptoms like heartburn or stomach pain about twice a week and are generally healthy may be suitable candidates. As an unphased trial, this study provides an opportunity to contribute to scientific understanding and potentially find relief from discomfort.

Do I have to stop taking my current medications for this trial?

The trial requires that you have not taken certain medications, like proton pump inhibitors or antibiotics, in the last 12 weeks. If you're taking other medications not related to gut health, you must have been on them consistently for at least three months. You should not introduce any new supplements or medications during the trial.

What prior data suggests that Limosilactobacillus reuteri DSM 17648 is safe for humans?

Research has shown that Limosilactobacillus reuteri DSM 17648 is generally safe for people. Studies have found that this supplement can enhance the effectiveness of some stomach treatments without causing major side effects. In trials where participants used this supplement, no significant adverse reactions were reported. This suggests it is safe for most people, though individual responses can vary. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Limosilactobacillus reuteri DSM 17648 for indigestion because it introduces a new, natural approach to managing digestive discomfort. Unlike standard treatments that often rely on antacids or proton pump inhibitors to reduce stomach acid, this treatment utilizes a probiotic strain to potentially balance gut bacteria and improve digestion. This unique mechanism of action not only targets the root cause of indigestion but also supports overall gut health, making it a promising alternative for those seeking a more holistic solution.

What evidence suggests that Limosilactobacillus reuteri DSM 17648 might be an effective treatment for indigestion?

Research has shown that Limosilactobacillus reuteri DSM 17648, which participants in this trial may receive, can aid in alleviating stomach and digestive issues. Studies have found that this postbiotic, a non-living form of the bacteria, enhances treatments for eradicating H. pylori, a common stomach bacterium. It has alleviated symptoms such as indigestion, constipation, and stomach pain. Participants using this treatment have reported significant improvement in these symptoms. This suggests that L. reuteri DSM 17648 might relieve discomfort in the upper digestive area. ^{2 3 5 6 7}

Who Is on the Research Team?

Swathi Varanasi

Principal Investigator

Citruslabs

Are You a Good Fit for This Trial?

Healthy adults aged 30-70 with a BMI ≤32 kg/m² experiencing upper gastrointestinal discomfort, such as heartburn or stomach pain, and an FSSG score ≥8. Participants must not have uncontrolled chronic conditions or substance abuse history and agree to not start new supplements or medications during the trial.

Inclusion Criteria

I am either male or female.

I am between 30 and 70 years old.

My BMI is 32 or lower.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take L. reuteri DSM 17648 supplement or placebo daily for 8 weeks, answer questionnaires bi-weekly, and provide stool samples at baseline and end of study

8 weeks

Bi-weekly questionnaires, stool samples at baseline and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Limosilactobacillus Reuteri DSM 17648

Trial Overview The trial is testing if a food supplement containing Limosilactobacillus reuteri DSM 17648 can reduce symptoms of indigestion over 8 weeks compared to a placebo. It also examines effects on quality of life, stress levels, and gut microbiota through questionnaires and stool samples.

How Is the Trial Designed?

Group I: Limosilactobacillus reuteri DSM 17648 Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

Participant will take one capsule of placebo once per day with liquid during or immediately after the main meal, for 8 weeks.

Who Is Running the Clinical Trial?

Novozymes A/S

Lead Sponsor

Trials

13

Recruited

840+

Citruslabs

Industry Sponsor

Trials

94

Recruited

5,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39023173/

A Randomized Double-Blind Placebo-Controlled Trial The postbiotic containing inactivated L. reuteri DSM 17648 significantly improves the effectiveness of H. pylori eradication therapy in FD and decreases ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07163637

Effect of Limosilactobacillus Reuteri DSM 17648 in Healthy ... The goal of this clinical trial is to learn if the food supplement containing a postbiotic (inanimate) Limosilactobacillus reuteri DSM 17648 ...

3. journals.lww.com journals.lww.com/ctg/fulltext/2024/09000/efficacy_and_safety_of_postbiotic_contained.7.aspx

Efficacy and Safety of Postbiotic Contained Inactivated... The postbiotic containing inactivated L. reuteri DSM17648 significantly improves the effectiveness of H. pylori eradication therapy in FD and decreases overall ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37614081/

Probiotic containing Lactobacillus reuteri DSM 17648 as ... The probiotic group showed significant pre- to post-treatment reductions in indigestion, constipation, abdominal pain, and total GSRS scores.

5. frontiersin.org frontiersin.org/journals/cellular-and-infection-microbiology/articles/10.3389/fcimb.2022.1042070/pdf

Current and future perspectives for Helicobacter pylori ... These clinical studies have shown that L. reuteri DSM 17648 formulation is safe and effective in reducing H. pylori load in adults and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11421730/

Efficacy and Safety of Postbiotic Contained Inactivated ... The aim of this study was to evaluate the efficacy and safety of postbiotic containing inactivated (nonviable) Limosilactobacillus (Lactobacillus) reuteri DSM ...

7. researchgate.net researchgate.net/publication/376524122_Efficacy_and_Safety_of_Postbiotic_Metabiotic_Contained_Inactivated_Lactobacillus_reuteri_Limosilactobacillus_Reuteri_DSM_17648_as_Adjuvant_Therapy_in_the_Eradication_of_Helicobacter_pylori_in_Adults_w

Efficacy and Safety of Postbiotic (Metabiotic) Contained ... The postbiotic (metabiotic) contained inactivated L. reuteri DSM 17648 significantly improves the effectiveness of H. pylori eradication therapy in FD.