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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if supplementing healthy term infants delivered by C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Bifidobacterium for healthy infants?

Research shows that Bifidobacterium, a type of probiotic, can help reduce diarrhea in infants and positively influence gut bacteria, which is important for overall health. Studies have found that infants given Bifidobacterium-supplemented formula had fewer diarrhea episodes and changes in gut bacteria that may benefit their health. ^{1 2 3 4 5}

Is it safe to give probiotics like Bifidobacterium to infants?

Research shows that probiotics, including Bifidobacterium strains, are generally safe and well tolerated in infants. Studies found no serious adverse events and normal growth patterns in infants who received these probiotics. ^{6 7 8 9 10}

How does the treatment Bifidobacterium differ from other treatments for infant health?

Bifidobacterium, particularly B. infantis, is unique because it is specifically adapted to thrive in the infant gut and works symbiotically with human milk to support a healthy gut microbiota. Unlike other treatments, it helps balance the immune system, reduces inflammation, and improves gut health by increasing beneficial bacteria and producing substances like acetic acid that lower stool pH. ^{8 11 12 13 14}

Research Team

Jennifer Smilowitz, PhD

Principal Investigator

University of California, Davis

Mark Underwood, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

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

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of early administration of probiotics on gut microflora and feeding in pre-term infants: a randomized controlled trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Bifidobacterium longum subsp infantis CECT7210-supplemented formula reduces diarrhea in healthy infants: a randomized controlled trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Translating neonatal microbiome science into commercial innovation: metabolism of human milk oligosaccharides as a basis for probiotic efficacy in breast-fed infants. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial on the impact of early-life intervention with bifidobacteria on the healthy infant fecal microbiota and metabolome. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A comparison of two probiotic strains of bifidobacteria in premature infants. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and tolerance of three probiotic strains in healthy infants: a multi-centre randomized, double-blind, placebo-controlled trial. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Early Probiotic Supplementation of Healthy Term Infants with Bifidobacterium longum subsp. infantis M-63 Is Safe and Leads to the Development of Bifidobacterium-Predominant Gut Microbiota: A Double-Blind, Placebo-Controlled Trial. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Review and Perspectives on Bifidobacterium lactis for Infants' and Children's Health. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Tolerance and safety of Lactobacillus paracasei ssp. paracasei in combination with Bifidobacterium animalis ssp. lactis in a prebiotic-containing infant formula: a randomised controlled trial. [2009]

11. United States pubmed.ncbi.nlm.nih.gov

Bifidobacterium infantis as a probiotic in preterm infants: a systematic review and meta-analysis. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

Bifidobacteria: their impact on gut microbiota composition and their applications as probiotics in infants. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Bifidobacterium longum Subspecies infantis (B. infantis) in Pediatric Nutrition: Current State of Knowledge. [2021]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Role of Bifidobacteria on Infant Health. [2021]