Probiotic Transmission Between Infants

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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.34678

Who Is on the Research Team?

DT

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

Healthy singleton pregnancy, term delivery (>= 36 weeks corrected gestational age)
Maternal intent to exclusively breastfeed for the first six months of infant life
I am a mother vaccinated against COVID19 with the required doses and timeline.

Exclusion Criteria

Maternal drug abuse
Infant congenital abnormalities
I plan to give my infant probiotics not part of the study.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive a daily probiotic (either HMO consuming or non-HMO consuming) for four weeks

4 weeks
5 visits (in-person, weekly lactation support groups)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • B. longum subsp. infantis
  • L. reuteri probiotic
Trial Overview The study tests if beneficial bacteria like B. longum subsp. infantis and L. reuteri can be transmitted between infants during lactation support groups by comparing HMO-consuming and non-HMO consuming probiotics through stool samples before and after attendance.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Non-HMO consuming bacteriaExperimental Treatment1 Intervention
Group II: HMO consuming bacteriaExperimental Treatment1 Intervention

B. longum subsp. infantis is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Bifidobacterium longum subspecies infantis for:
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Approved in European Union as Bifidobacterium longum subspecies infantis for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Published Research Related to This Trial

In a study involving 122 healthy term infants, those fed a partially hydrolyzed whey formula with Lactobacillus reuteri showed similar growth patterns in weight, length, and head circumference compared to those fed a formula without the probiotic.
Both formulas were well tolerated, with no significant differences in formula intake, stool characteristics, or adverse events, indicating that adding L. reuteri does not negatively impact infant health.
Growth and Tolerance of Term Infants Fed Formula With Probiotic Lactobacillus reuteri.Cekola, PL., Czerkies, LA., Storm, HM., et al.[2022]
The study analyzed gut bacteria from 31 healthy mother-infant pairs from two distinct ethnic groups, revealing significant differences in the composition and number of Lactobacillus species between the groups.
Lactobacillus paracasei strains showed evidence of vertical transmission from mother to infant, with strains from the same ethnic group clustering together, suggesting ethnic specificity in probiotic bacteria that could inform personalized probiotic development for maternal and child health.
Ethnic Specificity of Species and Strain Composition of Lactobacillus Populations From Mother-Infant Pairs, Uncovered by Multilocus Sequence Typing.Yuan, L., Zhang, X., Luo, B., et al.[2022]
Lactobacillus gasseri and Lactobacillus reuteri are the predominant autochthonous species found in both infants and adults, indicating their importance in the human gut microbiome.
The composition of bifidobacterial species varies significantly between infants and adults, with specific species like B. bifidum and B. infantis being more common in infants, while adults show a prevalence of B. adolescentis, highlighting the dynamic nature of gut microbiota throughout different life stages.
The Lactobacillus and Bifidobacterium microflora of the human intestine: composition and succession.Reuter, G.[2006]

Citations

Safety, efficacy, and impact on gut microbial ecology of a ...B. infantis LMG11588 supplementation was associated with normal infant growth, was safe and well-tolerated and promoted a Bifidobacterium-rich microbiota.
Bifidobacterium longum Subspecies infantis (B. ...B. infantis is well adapted to the infant gut and has co-evolved with the mother-infant dyad and gut microbiome, in part due to its ability to consume complex ...
Longitudinal quantification of Bifidobacterium longum ...We developed a high-throughput method to quantify Bifidobacterium longum subsp. infantis (BL. infantis), a proficient HMO-utilizer, and applied it to a ...
Impact of Bifidobacterium longum Subspecies infantis on ...infantis supplementation exhibited reduced levels of potential gut pathogens, decreased GI inflammation, and fewer antibiotic resistance genes ...
Clinical Impact of Infant-Type Bifidobacteria - A Systematic ...We found that early administration of ITB probiotics was associated with a significant reduction in eczema (RR = 0.78 [0.68, 0.90]) and a ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/28558732/
Safety and tolerability of Bifidobacterium longum ...Conclusions: The B. infantis EVC001 supplement was safely consumed and well-tolerated. Stools were fewer and better formed in infants in the ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38162520/
a randomized, double-blind, controlled trial in the PhilippinesB. infantis LMG11588 supplementation was associated with normal infant growth, was safe and well-tolerated and promoted a Bifidobacterium-rich microbiota.
Safety and Tolerance of Bifidobacterium longum subsp. ...According to previous studies, a high dose of B. infantis (1.8–2.8 × 1010 CFUs/day) is safe and well-tolerated in healthy infants [13,15]. Figure 1. ...
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