Probiotic Transmission Between Infants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if certain probiotics can transfer between infants attending lactation support groups. The researchers are testing two types of probiotics: one with human milk oligosaccharides (HMO) and one without. They seek to discover if HMO-related bacteria, specifically Bifidobacterium longum subspecies infantis (B. longum subsp. infantis), spread more easily among infants. Mothers who plan to exclusively breastfeed their healthy, term infants and have received a COVID-19 vaccination would be ideal participants. As an unphased trial, this study provides a unique opportunity to enhance understanding of the natural spread of beneficial bacteria among infants.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does not mention any requirement to stop medications, so you likely won't have to.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both probiotics tested in this study are safe for babies.
For the B. longum subsp. infantis probiotic, studies have found it to be well-tolerated by infants. One study found no safety issues and noted that it supported normal growth in babies. Another study showed that even a high dose was safe, with babies experiencing fewer and better-formed stools.
Regarding the L. reuteri probiotic, studies also confirm its safety in infants. Research shows no safety concerns when used in healthy babies. It has been safely used to treat colic (excessive crying) and diarrhea in infants.
Overall, both probiotics have demonstrated safety for babies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these probiotic treatments for infants because they explore how beneficial bacteria can be transferred and thrive in the developing gut. Unlike traditional treatments for digestive health that often involve medication or diet changes, these treatments use specific probiotics: B. longum subsp. infantis and L. reuteri. B. infantis is unique because it consumes human milk oligosaccharides (HMOs), which are complex sugars in breast milk, potentially enhancing its effectiveness in populating infants’ intestines. Meanwhile, L. reuteri offers another approach by promoting gut health without relying on HMOs. By testing these two different probiotics, researchers hope to discover new ways to support infant gut health naturally.
What evidence suggests that this trial's treatments could be effective?
In this trial, infants will receive either B. longum subsp. infantis or L. reuteri probiotics. Research has shown that B. longum subsp. infantis can improve infant gut health by reducing harmful bacteria and lowering gut inflammation. It aids infant growth and supports a healthy gut microbiome, the community of bacteria in the gut. Studies have also found that it can reduce the risk of eczema, a skin condition.
For L. reuteri, studies have shown it can shorten the duration of diarrhea in children and ease symptoms of infant colic, such as crying. It supports gut health by improving stool consistency and frequency, making it safe for infants. Both probiotics show promise in supporting infant gut health.34678Who Is on the Research Team?
Diana Taft, BA, PhD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for mothers intending to exclusively breastfeed for six months, with healthy single babies born at term (>=36 weeks), and who are vaccinated against COVID-19. Infants older than one month, those given non-study probiotics, with congenital abnormalities or immunocompromised status cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive a daily probiotic (either HMO consuming or non-HMO consuming) for four weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- B. longum subsp. infantis
- L. reuteri probiotic
B. longum subsp. infantis is already approved in United States, European Union for the following indications:
- Infant gut health support
- Colic management
- Infant gut health support
- Allergy prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor