Probiotic Transmission Between Infants

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Maternal drug abuse, Infant congenital abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

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. ^{1 2 3 4 5}

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. ^{3 4 6 7 8}

Who 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

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.

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?

Group I: Non-HMO consuming bacteria Experimental Treatment 1 Intervention

Infants will be given a daily non-HMO consuming probiotic (L. reuteri) for four weeks

Group II: HMO consuming bacteria Experimental Treatment 1 Intervention

Infants will given a daily HMO consuming probiotic (B. infantis) for four weeks

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:

• Infant gut health support
• Colic management

Approved in European Union as Bifidobacterium longum subspecies infantis for:

• Infant gut health support
• Allergy prevention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Lactobacillus and Bifidobacterium microflora of the human intestine: composition and succession. Reuter, G.[2006]

The study identified key species of bifidobacteria (B. longum, B. adolescentis, B. infantis) and lactobacilli (L. acidophilus, L. rhamnosus) in clinically healthy young children, highlighting their potential role in gut health.

Selected strains, particularly B. longum strain 58B and L. rhamnosus strain 12L, demonstrated strong acid-forming and antagonistic activities against harmful bacteria, suggesting they could be developed into effective probiotics for improving intestinal microflora in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Search of promising strains of bifidobacteria and lactobacillus for the development of new biopreparations]. Postnikova, EA., Efimov, BA., Volodin, NN., et al.[2020]

Nine strains of Lactobacillus reuteri isolated from human infant feces demonstrated high tolerance to harsh gastrointestinal conditions, such as acid and bile, suggesting they can survive and exert probiotic effects in the human gut.

These strains showed no signs of antibiotic resistance or harmful activities, indicating they are safe for potential use as probiotics in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of Intestinal Lactobacillus reuteri Strains as Potential Probiotics. Singh, TP., Kaur, G., Malik, RK., et al.[2018]

Probiotic-supplemented infant formulae do not negatively impact growth or cause adverse effects in healthy infants, indicating they are safe for use.

While some probiotics, like Bifidobacterium lactis Bb12, showed benefits such as reducing gastrointestinal infections and colic, there is insufficient robust evidence to recommend routine use of these supplements in infant formula.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To add or not to add probiotics to infant formulae? An updated systematic review. Skórka, A., Pieścik-Lech, M., Kołodziej, M., et al.[2018]

A clinical trial is being conducted with 250 children under 18 years old to evaluate the effectiveness of Lactobacillus reuteri DSM 17938 in preventing antibiotic-associated diarrhoea (AAD) during antibiotic treatment.

The study will measure the frequency of diarrhoea and AAD using specific definitions, aiming to establish the safety and efficacy of this probiotic strain in a double-blind, placebo-controlled setup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus reuteri DSM 17938 in the prevention of antibiotic-associated diarrhoea in children: protocol of a randomised controlled trial. Kołodziej, M., Szajewska, H.[2022]

In a study of infants from Bangladesh, Pakistan, and Tanzania, the presence of Bifidobacterium infantis was linked to fewer viral infections, suggesting it may help protect against certain enteric viruses, although it did not reduce overall diarrheal disease risk.

The analysis indicated that suboptimal intrauterine growth and shorter exclusive breastfeeding duration could lead to increased colonization of Bifidobacterium longum at the expense of Bifidobacterium infantis, potentially depriving infants of its protective benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal Colonization With Bifidobacterium longum Subspecies Is Associated With Length at Birth, Exclusive Breastfeeding, and Decreased Risk of Enteric Virus Infections, but Not With Histo-Blood Group Antigens, Oral Vaccine Response or Later Growth in Three Birth Cohorts. Colston, JM., Taniuchi, M., Ahmed, T., et al.[2022]

In a double-blind trial involving 232 mothers, oral supplementation with Lactobacillus reuteri significantly increased its prevalence in infants' stool samples during the first year of life, especially notable at 5 to 6 days of age (82% in the treated group vs. 20% in placebo).

The study found that while Lactobacillus reuteri could be detected in breast milk after maternal supplementation, it did not affect the colonization of beneficial Bifidobacterium or harmful Clostridium difficile, suggesting a specific role in infant gut health without altering overall microbial ecology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic lactobacilli in breast milk and infant stool in relation to oral intake during the first year of life. Abrahamsson, TR., Sinkiewicz, G., Jakobsson, T., et al.[2022]

A study involving 221 healthy infants aged 3 to 12 months found that three probiotic strains (Bifidobacterium longum subsp. infantis R0033, Bifidobacterium bifidum R0071, and Lactobacillus helveticus R0052) were safe and well tolerated over an 8-week period, with no serious adverse events reported.

Growth measurements (weight, height, and head circumference) were similar across all groups, indicating that these probiotics do not negatively impact infant growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerance of three probiotic strains in healthy infants: a multi-centre randomized, double-blind, placebo-controlled trial. Manzano, S., De Andrés, J., Castro, I., et al.[2018]

A phase-one placebo-controlled study involving 60 children aged 2-5 years tested the safety and efficacy of Lactobacillus reuteri DSM 17938 for treating diarrhea in a resource-constrained community in Peru.

The study found no significant differences in objective adverse events between the probiotic and placebo groups, although some subjective parental reports indicated differences in fever and diarrhea symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age. Kosek, MN., Peñataro-Yori, P., Paredes-Olortegui, M., et al.[2022]

In a study of 37 infants, those who received probiotics showed a significant increase in beneficial bacteria like Bifidobacteria during supplementation, but these effects did not persist after the treatment ended.

Overall bacterial colonization patterns in infants were similar regardless of probiotic administration, indicating that while probiotics can temporarily boost certain bacteria, they do not fundamentally alter the long-term gut microbiota composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a milk formula containing probiotics on the fecal microbiota of asian infants at risk of atopic diseases. Mah, KW., Chin, VI., Wong, WS., et al.[2022]

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