Probiotics for Imbalance of Microbes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the probiotic Lactobacillus rhamnosus GG can balance gut microbes disrupted by the common acid reflux medication omeprazole. The researchers aim to determine if this probiotic positively affects gut health by comparing it to a placebo. Participants will receive either the probiotic or a placebo while taking omeprazole. Healthy individuals without ongoing gut issues who follow a regular diet, free from restrictions or fad diets, might be suitable for this study. As an unphased trial, it offers participants the chance to contribute to understanding the potential benefits of probiotics on gut health.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Lactobacillus rhamnosus GG (LGG) is generally safe for people. One study found that LGG is safe and can improve gut health. Another study demonstrated that LGG supports healthy gut bacteria, indicating it is well-tolerated.
Omeprazole, the other treatment in the trial, is an FDA-approved medication for acid reflux that reduces stomach acid. It is commonly prescribed and considered safe for most people, though it can have side effects like any medication.
Overall, evidence supports the safety of both treatments in this trial for human use in other situations.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using Lactobacillus rhamnosus GG for addressing microbial imbalances because it introduces a probiotic approach, which isn't typically part of standard treatments like antibiotics or acid suppressors such as omeprazole. Unlike these common options that may reduce symptoms by altering stomach acid or directly targeting bacteria, Lactobacillus rhamnosus GG works by promoting the growth of beneficial bacteria, potentially restoring balance naturally. This unique mechanism can lead to fewer side effects and a more holistic restoration of gut health, making it a promising alternative in the field.
What evidence suggests that Lactobacillus rhamnosus GG might be an effective treatment for imbalance of microbes?
Research has shown that Lactobacillus rhamnosus GG (LGG) helps maintain gut health. In individuals with short bowel syndrome, it supports gut health by activating specific bodily processes. LGG increases the production of butyrate, a substance that protects the gut from harmful toxins. It also reduces diarrhea and stomach pain in children with gut issues such as irritable bowel syndrome. In this trial, one group of participants will receive LGG alongside omeprazole to evaluate its effectiveness in maintaining a healthy gut balance, particularly against changes caused by proton pump inhibitors (PPIs).46789
Who Is on the Research Team?
John DiBaise, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lactobacillus rhamnosus GG
- Omeprazole
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor