Probiotics for Healthy Infants

(IMPRINT Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Infant complications, Formula feeding, others

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

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if giving a probiotic called Bifidobacterium to exclusively breastfed newborns can increase the good bacteria in their guts. Infants will join either a supplement group, receiving the probiotic, or a control group, receiving standard care. Families near the University of California Davis, with newborns 0-7 days old from healthy, full-term pregnancies, and who plan to exclusively breastfeed for at least three months, might be a good fit.

As an unphased trial, this study offers families the chance to contribute to groundbreaking research on infant gut health.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Bifidobacterium infantis, the probiotic under testing, is safe and well-tolerated in babies. In earlier studies, babies who took B. infantis grew normally and had fewer, better-formed bowel movements, suggesting improved digestion. Another study found that even a high dose of B. infantis was safe for healthy babies. Additionally, the FDA has approved B. infantis as safe for use in baby formulas. These findings suggest that the probiotic is generally safe for babies, supporting its use in the current study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Bifidobacterium, specifically B. infantis, for infants because it offers a natural and potentially safer way to support gut health. Unlike traditional treatments that might involve medications or formulas, B. infantis is a probiotic that works by populating the infant gut with beneficial bacteria, promoting a healthier digestive system. This approach is unique because it enhances the body's natural processes rather than replacing them, potentially reducing the risk of side effects associated with more conventional treatments.

What evidence suggests that Bifidobacterium might be an effective treatment for increasing bacteria levels in infants' stool?

Studies have shown that *Bifidobacterium infantis* can increase the amount of beneficial bacteria in the gut of healthy babies. Research indicates that early administration of *B. infantis* is safe and fosters a gut environment where this beneficial bacteria thrives. This trial will compare two groups: one will receive standard care plus lactation consultation, while the other will receive probiotic *B. infantis* supplementation in addition to standard care and lactation consultation. This is particularly important for babies born by C-section, as they might naturally have fewer of these beneficial bacteria. Overall, *B. infantis* is considered safe and has been linked to positive changes in the gut microbiota, the community of tiny organisms living in infants' digestive systems. These findings suggest that using *B. infantis* could support a healthy gut in newborns. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer Smilowitz, PhD

Principal Investigator

University of California, Davis

Mark Underwood, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for healthy, non-smoking women in their third trimester or who have recently given birth and plan to exclusively breastfeed for at least 3 months. Their infants must be 0-7 days old, delivered full-term without complications that affect breastfeeding or gut bacteria. Participants must live within a 20-mile radius of UC Davis locations.

Inclusion Criteria

Healthy, non-smoking women and their infants

Who are pregnant in their third trimester OR have delivered by C-section or vaginal birth within the past 7 days

Plan to exclusively breastfeed their infants for at least 3 months

Exclusion Criteria

Mothers and their infants who are not discharged from the hospital by day 4 of life due to complications

My newborn has complications like breathing issues, birth defects, or infections.

I plan to give my infant probiotics or use non-study probiotics during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive probiotic B. infantis supplementation for 21 consecutive days

3 weeks

Multiple visits for sample collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits at months 4, 6, 8, 10, 12, 18, and 24

What Are the Treatments Tested in This Trial?

Interventions

• Bifidobacterium

Trial Overview The study tests if giving Bifidobacterium probiotics to healthy newborns (delivered via C-section or vaginal birth) increases beneficial bacteria in their stool over a period of 21 days.

How Is the Trial Designed?

Group I: Supplement Group Experimental Treatment 1 Intervention

This group will receive probiotic B. infantis supplementation, plus standard care and lactation consultation.

Group II: Control Group Active Control 1 Intervention

This group will receive standard care plus lactation consultation only.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Evolve BioSystems, Inc.

Industry Sponsor

Trials

8

Recruited

710+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7352178/

Bifidobacterium longum Subspecies infantis (B. infantis) in ... Overall, the authors concluded that formula with added CECT was safe, effective, and well tolerated in healthy term infants. 2.3.6. B. infantis ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S002231662500625X

Clinical Impact of Infant-Type Bifidobacteria - A Systematic ... This systematic review evaluates the clinical effects of administering ITB probiotics to healthy, term infants within the first year of life.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10055625/

Early Probiotic Supplementation of Healthy Term Infants ... These results indicate that early supplementation with B. infantis M-63 is well tolerated and contributes to the development of Bifidobacterium-predominant gut ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06452199

The BEGIN Study Bifidobacterium Infantis to Newborns ... The goal of The BEGIN Study, a randomized controlled double-blinded intervention trial, is to learn if probiotics, with Bifidobacterium longum subspecies ...

5. nature.com nature.com/articles/s41390-023-02716-w

Bifidobacterium infantis as a probiotic in preterm infants These results provide indirect evidence that probiotic supplements that include B. infantis may be more beneficial for preterm infants.

6. nature.com nature.com/articles/s41390-020-01350-0

Early probiotic supplementation with B. infantis in breastfed ... The gut of infants enriched with the genus Bifidobacterium and low levels of potential pathogens decreases the risk of autoimmune diseases,15, ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28558732/

Safety and tolerability of Bifidobacterium longum ... The B. infantis EVC001 supplement was safely consumed and well-tolerated. Stools were fewer and better formed in infants in the BiLS group compared with LS ...

8. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1319873/full

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.

9. mdpi.com mdpi.com/2072-6643/17/13/2127

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. ...

10. fda.gov fda.gov/media/171775/download

GRAS Notice 1107, Bifidobacterium longum subsp. infantis ... Bifidobacterium longum ssp. infantis LMG 11588 is intended to be added to powder non-exempt infant formula and toddler drinks for healthy ...