Probiotics for Imbalance of Microbes

Overseen By Yonas Berhe, B.S

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Proton pump inhibitors

Must not be taking: GI secretion medications

Disqualifiers: GI surgery, GI diseases, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who use medications daily that affect gastrointestinal function.

What data supports the effectiveness of the treatment Lactobacillus rhamnosus GG, Omeprazole, Losec, Prilosec, Zegerid, Omez, Placebo, Control, Dummy Treatment for imbalance of microbes?

Research suggests that Lactobacillus rhamnosus GG can help prevent gastrointestinal and respiratory infections in children with gastroesophageal reflux disease who are treated with proton pump inhibitors like omeprazole. This indicates that the probiotic may help maintain a healthier balance of microbes in the gut. ^{1 2 3 4 5}

Is the treatment with Lactobacillus rhamnosus GG and omeprazole generally safe for humans?

Lactobacillus rhamnosus GG is used to prevent infections in children taking omeprazole, and omeprazole is a common medication for stomach issues, but it may cause bacterial overgrowth in the stomach. While omeprazole is generally considered safe, it has been linked to an increased risk of certain infections, and its impact on gut bacteria is mild and temporary. ^{2 3 4 5 6}

How is the treatment with Lactobacillus rhamnosus GG and Omeprazole unique for microbial imbalance?

This treatment is unique because it combines a probiotic, Lactobacillus rhamnosus GG, with Omeprazole, a common acid-reducing drug, to address the imbalance of microbes caused by long-term use of acid-reducing medications. The probiotic helps restore the 'gastric barrier effect' by reducing harmful bacterial overgrowth, which is a side effect of using Omeprazole. ^{2 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to investigate the impact of the probiotic Lactobacillus rhamnosus (LGG) on proton pump inhibitor (PPI)-induced changes to the microbes that live in the gastrointestinal tract and are passed out in the stool. PPI medicines reduce stomach acid and are commonly used to treat acid reflux disease.

Research Team

John DiBaise, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for healthy individuals who eat a regular diet with no restrictions and have no chronic gastrointestinal symptoms. Pregnant people, those on daily GI medications, anyone with prior significant GI surgery (except appendectomy), or systemic diseases affecting GI motility are excluded.

Inclusion Criteria

Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.

I do not have any symptoms.

Individuals on an unrestricted regular diet with no dietary restrictions (vegan, low FODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.).

Exclusion Criteria

I do not have any untreated mental health issues or diseases that affect my stomach or intestines' movement.

Pregnancy.

I regularly take medication that affects my stomach or bowel movements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive omeprazole daily for 56 days. After 28 days, they receive either placebo or Lactobacillus rhamnosus GG two capsules daily taken with a meal.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lactobacillus rhamnosus GG
• Omeprazole
• Placebo

Trial Overview The study examines the effects of Lactobacillus rhamnosus GG (a probiotic) on gut health in participants taking Omeprazole, a medication that reduces stomach acid. Some will receive the probiotic while others will get a placebo to compare outcomes.

Participant Groups

Group I: Lactobacillus rhamnosus GG Group Experimental Treatment 2 Interventions

Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive Lactobacillus rhamnosus GG two capsules daily taken with a meal.

Group II: Placebo Group Placebo Group 2 Interventions

Subjects will receive omeprazole daily for 56 days. After 28 days, subjects will receive placebo two capsules daily taken with a meal.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of a specially designed fermented milk product containing probiotic Lactobacillus casei DN-114 001 and the eradication of H. pylori in children: a prospective randomized double-blind study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The innovative potential of Lactobacillus rhamnosus LR06, Lactobacillus pentosus LPS01, Lactobacillus plantarum LP01, and Lactobacillus delbrueckii Subsp. delbrueckii LDD01 to restore the "gastric barrier effect" in patients chronically treated with PPI: a pilot study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Ameliorating Effect of Lactobacillus gasseri OLL2716 on Functional Dyspepsia in Helicobacter pylori-Uninfected Individuals: A Randomized Controlled Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Correlation between chronic treatment with proton pump inhibitors and bacterial overgrowth in the stomach: any possible beneficial role for selected lactobacilli? [2018]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Lactobacillus rhamnosus GG Usage in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children with Gastroesophageal Reflux Disease Treated with Proton Pump Inhibitors: A Randomized Double-Blinded Placebo-Controlled Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Omeprazole Minimally Alters the Fecal Microbial Community in Six Cats: A Pilot Study. [2020]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Estimation of Probiotic Lactobacilli Drug Resistance]. [2016]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Probiotics and Helicobacter pylori eradication. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Probiotic intervention decreases serum gastrin-17 in Helicobacter pylori infection. [2015]

10. England pubmed.ncbi.nlm.nih.gov

The efficacy of Lactobacillus acidophilus and rhamnosus in the reduction of bacterial load of Helicobacter pylori and modification of gut microbiota-a double-blind, placebo-controlled, randomized trial. [2021]