Human Bifidobacterium M-63 Confirmed to Show Beneficial Effects on Bowel Habits and Intestinal Environment in Infants and Young Children After Weaning ~Published in 'Pediatric Research'~

For over 50 years, Morinaga Milk Industry has been conducting basic research on bifidobacteria that inhabit the human gut and offer various health benefits. Furthermore, under a comprehensive partnership agreement with Matsumoto City, Nagano Prefecture*1, the company has long conducted clinical research on functional ingredients, utilizing its findings for public health promotion and its own material development.

This time, through joint research with Matsumoto City Hospital*2, it has been confirmed that the intake of human Bifidobacterium M-63 improves bowel habits and has beneficial effects on the intestinal environment of infants and young children after weaning. Moreover, in groups with a relatively high risk of infection, it was suggested that the intake of Bifidobacterium M-63 is associated with a reduction in the number of days with cold-like symptoms and other factors. These research results were published in the scientific journal 'Pediatric Research' on April 29, 2026*3.

1. Research Background

Infancy and early childhood are known as highly variable periods where physical growth and development progress remarkably, and the intestinal environment also rapidly changes and matures under the influence of breast milk and weaning foods. Furthermore, with the progression of weaning, health issues such as bowel problems and increased infection risk tend to occur.

Against this background, regulating the intestinal environment has attracted attention as a promising approach to these challenges. In this study, we exploratively evaluated the effects of Bifidobacterium M-63 intake on the intestinal environment and health status of healthy infants and young children after weaning.

2. Research Methods

* Subjects: 100 healthy infants and young children aged 5 months to less than 3 years. * Study Design: Randomized, double-blind, placebo-controlled, parallel-group comparative study. * Test Food: Powder containing 5 billion Bifidobacterium M-63 per day, or placebo powder without Bifidobacterium M-63, continuously consumed for 8 weeks. * Evaluation Items: Bowel status, gut microbiota, fecal short-chain fatty acids*4, and health status.

What is Bifidobacterium M-63?

It is a Bifidobacterium strain belonging to Bifidobacterium longum subsp. infantis (hereinafter, B. infantis), discovered in the intestines of infants and exclusively researched by our company.

B. infantis is particularly compatible with breast milk among bifidobacteria inhabiting the human infant gut, and is thought to contribute to immune development and reduction of infection risk by producing beneficial metabolites in the intestines. Bifidobacterium M-63 has been reported to have a high ability to utilize human milk oligosaccharides contained in breast milk, and its early intake improves the intestinal environment and brings beneficial effects on immune function and bowel habits*5, 6. Furthermore, its high safety has been recognized overseas, such as obtaining FDA GRAS (Generally Recognized as Safe)*7 in the United States and being registered as a new food ingredient*8 in China.

Bifidobacterium M-63

3. Research Results

* In the Bifidobacterium M-63 intake group, the number of days with diarrhea decreased (Figure 1), and the number of days with normal bowel movements increased (Figure 2) compared to the placebo group. These results suggest the intestinal regulating effect of Bifidobacterium M-63 for infants and young children after weaning. * In the analysis stratified by breast milk intake status, the proportion of B. infantis significantly increased (Figure 3) in the group continuously consuming breast milk with Bifidobacterium M-63 intake. On the other hand, in the group not consuming breast milk, the total concentration of fecal short-chain fatty acids significantly increased (Figure 4). * Furthermore, results from a post-hoc exploratory analysis suggested that in groups with a relatively high risk of infection, such as "lower age in months" and "having siblings," Bifidobacterium M-63 intake was associated with a reduction in the number of days of antibiotic/probiotic use and the number of days with cold-like symptoms (Figure 5).

Figure 1: Number of days with diarrhea during test food intake period *Counts days where the average daily stool consistency was "6 or 7" on the Bristol Stool Scale.

Figure 2: Percentage of days with normal bowel movements *Calculated as "number of days with normal bowel movements / number of days with bowel movements" every two weeks.

Figure 3: Increase in the proportion of B. infantis in the gut in the group consuming breast milk.

Figure 4: Increase in total fecal short-chain fatty acid concentration in the group not consuming breast milk (change from before test food intake).

Figure 5: Comparison of days of medication/probiotic use and days with cold-like symptoms in groups with relatively high infection risk.

* p < 0.05, *** p < 0.001 indicate statistically significant differences compared to the placebo intake group.

(† p < 0.1 indicates a significant trend.)

§ p < 0.05, §§§ p < 0.001 indicate statistically significant differences compared to before intake.

4. Future Outlook

From these results, Bifidobacterium M-63 has been reported so far to be weaning