SACRAMENTO, Calif., Dec. 1, 2025 /PRNewswire/ -- Infinant Health, the company behind the Evivo® infant probiotic, today released an updated summary of the rapidly expanding global research involving Bifidobacterium longum subsp. infantis EVC001. More than a decade of clinical, mechanistic, and translational studies, along with several major ongoing international trials, underscore this strain's potential role in establishing a healthier infant gut microbiome and supporting immune development.

Bifidobacterium longum subsp. infantis (B. infantis) is widely recognized as a foundational microbe in early-life gut development, and its presence has been associated with lower levels of allergy and autoimmunity in observational research.

Real-World Results That Matter to Parents

Beyond laboratory and clinical findings, parents report meaningful improvements when using Evivo with their infants. Published research shows:

Parents report relief within days of feeding Evivo Baby Probiotic Powder

• 72% saw reduced diaper rash
  
  
• 63% observed less gas and fussiness
  
  
• 52% reported longer sleep

Evivo is clinically shown to work with HMOs, found in breast milk and some formulas, to:

• Replenish beneficial bacteria in 100% of babies
  
  
• Establish a healthier gut microbiome
  
  
• Support comfortable digestion
  
  
• Help nurture developing immune systems

Global Clinical Research Momentum

To date, the EVC001 strain has been evaluated in fourteen research studies in infants. Multiple independent groups are studying EVC001, including one of the world's most ambitious early-life immune-health trials:

GPPAD SINT1A Trial (Europe & UK)

The publicly announced SINT1A study, conducted by the Global Platform for the Prevention of Autoimmune Diabetes (GPPAD) and funded by The Leona M. and Harry B. Helmsley Charitable Trust, has fully enrolled 1,149 infants across several European countries and the UK.

This randomized, placebo-controlled primary-prevention trial is evaluating whether daily EVC001 supplementation during the first year of life can reduce the risk of developing type 1 diabetes–related autoimmunity.

SINT1A is the largest study to date investigating how an infant probiotic strain may influence autoimmune disease risk through the microbiome.

BACH Trial: Allergy Investigation

The BACH trial is a randomized, double-blind, placebo-controlled proof-of-concept study in which 286 infants received EVC001 during the first three months of life and were followed through age two for allergy development. Additional results and a full publication are anticipated next year.

These efforts build on previously published research showing that EVC001 can help reduce fecal pH, lower intestinal inflammation markers, and increase beneficial microbial metabolites - mechanisms linked to healthier immune development in early life.

Built on a Strong Foundation of Scientific Evidence

EVC001 is now one of the most extensively studied infant probiotics globally, supported by:

• Randomized controlled clinical trials
  
  
• Peer-reviewed publications
  
  
• Mechanistic studies on immune signaling and microbial metabolites
  
  
• More than 20 years of foundational academic research originating at UC Davis

To date, more than 5 million servings of Evivo have been consumed, supporting over 70,000 infants.

Commitment to Scientific Rigor

"From the beginning, Infinant Health has been dedicated to grounding everything we do in rigorous science," said Mike Johnson, CEO of Infinant Health. "These studies highlight how critical those first months of life may be for shaping lifelong health, and why the role of Evivo's B. infantis deserves this level of scientific attention."

About Infinant Health

About Infinant Health, Inc Infinant Health, Inc ("Infinant Health"), previously known as Evolve Biosystems, is a privately held company committed to changing the trajectory of human health through gut microbiome science. The company is building a product pipeline to optimize infant health. Past and present investors in the company include the Bill Gates Foundation, Johnson & Johnson, Cargill, and other leading institutions. www.infinanthealth.com
Learn more and purchase Evivo infant probiotic drops or powder products at www.evivo.com.

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SOURCE Infinant Health