# Bifidobacterium infantis M-63

**Canonical URL:** https://ingredients.hermeticasuperfoods.com/ingredients/bifidobacterium-infantis-m-63
**Data Source:** Hermetica Superfoods Ingredient Encyclopedia
**Updated:** 2026-04-02
**Evidence Score:** 2 / 10
**Category:** Fermented/Probiotic
**Also Known As:** B. infantis M-63, Bifidobacterium infantis strain M-63, B. infantis M63, Bifidobacterium infantis M63

## Overview

Bifidobacterium infantis M-63 is a specific [probiotic](/ingredients/condition/gut-health) strain that colonizes the infant gut and modulates immune responses by producing short-chain fatty acids and competing with pathogenic bacteria for epithelial binding sites. Its primary mechanism involves downregulating NF-κB-mediated [inflammatory](/ingredients/condition/inflammation) signaling, thereby reducing proinflammatory cytokines such as IL-6 and TNF-α in the neonatal gastrointestinal tract.

## Health Benefits

• Reduces infant gut [inflammation](/ingredients/condition/inflammation): Significantly decreased proinflammatory cytokines and calprotectin levels in a randomized controlled trial of 111 infants (PMID: 40681696)
• Improves gastrointestinal function: Reduced vomiting, constipation, and flatulence in formula-fed infants in a multicenter RCT of 66 infants (PMID: 28270216)
• Alleviates allergic rhinitis symptoms: Significant improvement in symptoms and quality of life in 40 children in a placebo-controlled trial (p < 0.005) (PMID: 28270216)
• Enhances mental well-being in IBS: Improved anxiety and bodily pain scores in 20 IBS patients after 3 months supplementation (p = 0.04) (PMID: 30525951)
• Establishes beneficial gut microbiota: Increases Bifidobacterium abundance while reducing pathogenic Enterobacteriaceae in multiple infant studies

## Mechanism of Action

B. infantis M-63 colonizes the infant intestinal epithelium and suppresses NF-κB activation, reducing transcription of proinflammatory cytokines including IL-6, IL-8, and TNF-α while lowering fecal calprotectin, a biomarker of intestinal [inflammation](/ingredients/condition/inflammation). The strain produces acetate and lactate through fermentation of human milk oligosaccharides (HMOs), acidifying the gut lumen and inhibiting colonization by pathogenic Enterobacteriaceae. Additionally, it upregulates tight-junction proteins such as occludin and claudin-1, strengthening the intestinal epithelial barrier and reducing paracellular permeability.

## Clinical Summary

A randomized controlled trial of 111 infants (PMID: 40681696) demonstrated that B. infantis M-63 supplementation significantly decreased proinflammatory cytokines and fecal calprotectin levels compared to placebo, providing strong evidence for its [anti-inflammatory](/ingredients/condition/inflammation) effects in the neonatal gut. A separate multicenter randomized trial in formula-fed infants showed clinically meaningful reductions in vomiting, constipation, and flatulence, suggesting improved gastrointestinal motility and comfort. Evidence is currently limited to infants and neonates, with most trials using strain-specific preparations; extrapolation to older populations or different Bifidobacterium strains is not supported by current data. Overall, the evidence base is promising but still emerging, with larger and longer-duration trials needed to confirm optimal dosing and long-term safety.

## Nutritional Profile

Bifidobacterium infantis M-63 is a live probiotic microorganism, not a conventional food ingredient, and thus does not contribute macronutrients (protein, fat, carbohydrates) or micronutrients in meaningful dietary quantities. Key bioactive components include: (1) Cell wall constituents — peptidoglycan and lipoteichoic acid fragments that interact with host Toll-like receptors (TLR-2, TLR-4), modulating innate immune signaling; (2) Exopolysaccharides (EPS) — strain-specific surface polysaccharides that facilitate gut epithelial adhesion and [immunomodulat](/ingredients/condition/immune-support)ion; (3) Short-chain fatty acids (SCFAs) — fermentation metabolites including acetate as the primary end-product of bifidobacterial [metabolism](/ingredients/condition/weight-management), with minor amounts of lactate, contributing to luminal pH reduction and colonocyte energy substrate; (4) B-vitamins — Bifidobacterium species are known producers of folate (B9) and riboflavin (B2) in nanogram-per-mL culture concentrations, though quantitative data specific to M-63 strain in vivo is limited; (5) Bacteriocin-like inhibitory substances (BLIS) — antimicrobial peptides produced at trace levels that suppress pathogenic competitors; (6) Indole derivatives and tryptophan metabolites — produced via [gut microbiome](/ingredients/condition/gut-health) cross-talk, supporting aryl hydrocarbon receptor (AhR) signaling relevant to immune tolerance. Typical commercial delivery dose is 1×10^8 to 1×10^9 CFU per serving. Bioavailability note: Viability through gastric acid and bile salts is strain-dependent; M-63 demonstrates moderate acid tolerance, and encapsulation or inclusion in formula matrix improves survival to the target intestinal site.

## Dosage & Preparation

Clinically studied dosages include: 1.0 × 10⁹ CFU daily for healthy infants from day 7 to 3 months of age; 10⁷-10⁹ CFU daily for formula-fed infants; 1.0 × 10⁹ CFU daily for 3 months in IBS patients; and 140 million CFU/g when enriched in infant formula. Consult a healthcare provider before starting any new supplement.

## Safety & Drug Interactions

B. infantis M-63 is generally considered safe for healthy term and near-term infants, with clinical trials reporting no serious adverse events attributable to the strain. In immunocompromised individuals, including premature neonates with very low birth weight, live [probiotic](/ingredients/condition/gut-health) administration carries a theoretical risk of bacteremia or sepsis, and use in these populations should be discussed with a physician. No significant drug interactions have been formally documented, though concurrent antibiotic use would be expected to reduce strain viability and diminish efficacy. Pregnancy and lactation safety data specific to this strain are not established; maternal supplementation studies are lacking and should be approached cautiously without medical guidance.

## Scientific Research

Multiple randomized controlled trials demonstrate B. infantis M-63's efficacy, including a study of 111 healthy infants showing [anti-inflammatory](/ingredients/condition/inflammation) effects (PMID: 40681696) and a multicenter RCT of 66 formula-fed infants demonstrating reduced gastrointestinal issues (PMID: 28270216). A controlled trial in 20 IBS patients revealed improvements in mental well-being and anxiety (PMID: 30525951), while ongoing trials are investigating prevention of type 1 diabetes and atopic dermatitis.

## Historical & Cultural Context

B. infantis M-63 has no traditional medicine history as it is a modern clinical isolate developed through contemporary microbiological research. The strain was specifically selected and developed based on scientific understanding of beneficial infant gut microbiota composition.

## Synergistic Combinations

Lactobacillus rhamnosus LCS-742, Bifidobacterium longum BB536, Bifidobacterium breve M-16V, Human Milk Oligosaccharides (HMOs), Acacia fiber

## Frequently Asked Questions

### What is Bifidobacterium infantis M-63 used for in infants?

B. infantis M-63 is used primarily to reduce gut inflammation and improve gastrointestinal comfort in formula-fed and breastfed infants. Clinical trials have shown it significantly lowers fecal calprotectin and proinflammatory cytokines while reducing symptoms such as vomiting, constipation, and flatulence.

### How does Bifidobacterium infantis M-63 differ from other Bifidobacterium strains?

M-63 is a specific subspecies strain of B. infantis with demonstrated ability to efficiently metabolize human milk oligosaccharides (HMOs) and colonize the neonatal gut at high levels. Unlike many commercially used strains such as B. longum or B. animalis, M-63 is specifically adapted to the infant gut environment and has been shown in RCTs to reduce calprotectin and cytokine markers, which are outcomes not consistently replicated across other strains.

### What dose of Bifidobacterium infantis M-63 was used in clinical trials?

Clinical trials investigating B. infantis M-63 in infants have typically used doses in the range of 1×10⁹ CFU (1 billion colony-forming units) per day administered orally, often mixed with formula or breast milk. Specific dosing protocols vary by study, and no universally established pediatric dosing guideline has been published as of current evidence.

### Is Bifidobacterium infantis M-63 safe for newborns and premature infants?

For healthy term newborns, B. infantis M-63 has demonstrated a favorable safety profile in randomized controlled trials with no reported serious adverse events. However, in premature or very-low-birth-weight infants with immature immune systems, there is a theoretical risk of probiotic-associated sepsis, and use in these vulnerable populations requires careful clinical evaluation and physician supervision.

### Does Bifidobacterium infantis M-63 reduce colic or crying in infants?

While B. infantis M-63 has been shown to reduce flatulence and gastrointestinal discomfort in formula-fed infants, direct evidence specifically quantifying reductions in colic episodes or total crying time for this strain is limited. Improvements in bowel regularity and gas production may indirectly reduce colic-associated distress, but dedicated colic-focused trials using M-63 specifically have not yet been widely published.

### What clinical evidence supports Bifidobacterium infantis M-63 for reducing gut inflammation in infants?

A randomized controlled trial of 111 infants demonstrated that Bifidobacterium infantis M-63 significantly decreased proinflammatory cytokines and calprotectin levels, indicating reduced intestinal inflammation. Calprotectin is a validated biomarker of gut inflammation, making this finding clinically meaningful for assessing bowel health in infants. This evidence suggests the strain has specific anti-inflammatory properties beneficial for infants with inflammatory gastrointestinal conditions.

### Which gastrointestinal symptoms does Bifidobacterium infantis M-63 improve in formula-fed infants?

A multicenter randomized controlled trial of 66 formula-fed infants found that Bifidobacterium infantis M-63 reduced vomiting, constipation, and flatulence compared to placebo. These improvements in digestive comfort are particularly relevant for formula-fed infants, who often experience different microbiota profiles than breastfed infants. The strain appears to promote more efficient digestion and reduce gas-related discomfort in this population.

### Is Bifidobacterium infantis M-63 effective for allergic rhinitis symptoms in children?

Clinical research indicates that Bifidobacterium infantis M-63 produces significant improvement in allergic rhinitis symptoms, suggesting a modulatory effect on immune tolerance and allergic responses. The strain may influence systemic immune function through gut-associated lymphoid tissue mechanisms. However, additional research is needed to establish optimal dosing and duration of use for allergic rhinitis management in pediatric populations.

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*Source: Hermetica Superfoods Ingredient Encyclopedia — https://ingredients.hermeticasuperfoods.com*
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