✓ No active regulatory warningsFDA MedWatch, EMA EudraVigilance, WHO VigiBase, WADA Prohibited List · 2026-05-29
📰Read the full Bifidobacterium evidence review on GMJ News →Complete clinical article, references and updates on news.gmj.ge. This page is the structured safety summary.⚠ B. infantis 35624 (Align) for IBS — n=362 trial is the IBS probiotic gold standard [2]
⚠ Strain code matters — generic 'Bifidobacterium' is meaningless [2]
⚠ Infant microbiome: Bifidobacterium dominance is critical for immune development [1]
ℹ️ Not obtained from food. Not applicable — obtained from fermented foods rather than measured toward a daily microgram/milligram target.
🔬 Lab interpreter
ℹ️ No validated blood test. There is no established laboratory test to assess status or guide dosing for this ingredient. Clinical response and symptoms are the practical guide.
⚕ For professionals — confirm ranges against your local laboratory.
Clinical verdict
B. infantis 35624 (Align) is the gold-standard IBS probiotic — Whorwell trial (n=362) is the best single-strain IBS trial. Bifidobacteria dominate infant gut (60–90%) and decline with aging. Strain specificity remains paramount. B. lactis BB-12 is the most documented Bifido for general immune/regularity [1] [2].
1 How much do I need?
👤 Adults: Specific dosage data under clinical review
👴 Elderly: Specific dosage data under clinical review
🤰 Pregnancy: See guidance
Generally safe. Some strains studied for infant allergy prevention [1].
👦 Pediatric: Specific dosage data under clinical review
🏃 Athletes: Standard dose
⚖️ Obesity: Standard dose
Fat-soluble compounds may require dose adjustment in obesity.
🩺 Renal: Consult specialist
Dose adjustment may be needed in renal impairment.
🌱 Vegan: Standard dose
How to take
🍽 Timing: With or without food [2].
💊 With food: Some strains survive better with food [2].
🚫 Avoid: Live probiotics in severely immunocompromised [1].
2 Which form?
| Form | Bioavailability | Vegan | Cost |
|---|---|---|---|
| ['B. infantis 35624 (Align)', 'preferred', 'Most studied for IBS. 1 billion CFU/day (low dose, strain-specific) [2].'] | Standard | Check label | |
| ['B. lactis BB-12', 'preferred', 'Most documented Bifidobacterium strain for immune function and regularity [2].'] | Standard | Check label | |
| ['B. longum BB536', '', 'Well-studied Japanese strain for immune and allergy support [2].'] | Standard | Check label | |
| ['Multi-strain Bifidobacterium blends', 'common', 'Common in commercial products [1].'] | Standard | Check label |
3 Common questions
What's the best Bifidobacterium for IBS? ▼
B. infantis 35624 (Align) — the Whorwell trial (n=362) is the gold standard IBS probiotic trial [2]. It's low-dose (1 billion CFU) and specifically effective for global IBS symptoms.
Why does Bifidobacterium decline with age? ▼
The mechanisms are unclear but involve dietary changes, antibiotic exposure, immune senescence, and reduced mucin production. This decline is associated with increased inflammation and disease risk in elderly [1].
Can I get Bifidobacterium from food? ▼
Some yogurts and fermented dairy specifically add Bifidobacterium. Standard fermented foods (sauerkraut, kimchi) typically contain Lactobacilli, not Bifidobacteria [1].
4 Clinical evidence
Strong
B. infantis 35624 for IBS: the pivotal Whorwell et al. trial (n=362) showed significant improvement in abdominal pain, bloating, and bowel habit vs placebo. Only strain with this level of IBS evidence [2]. Bifidobacterium dominance in infant gut: well-established microbiology [1]. HIGH
Moderate
B. lactis BB-12: improved bowel regularity and immune markers in multiple trials [2]. Infant health: B. longum spp. infantis promotes breast milk oligosaccharide utilization and immune development [1]. AAD prevention: some evidence alongside Lactobacillus [2]. Necrotizing enterocolitis prevention: meta-analysis supports probiotic combinations including Bifidobacterium in preterm infants [2]. MODERATE
Insufficient
5 Safety, toxicity & adverse events
Relative
⚠ Immunocompromised — theoretical risk
⚠ Severely ill ICU patients — avoid in acute pancreatitis
🚩 Red flags
● Severely immunocompromised — bacteremia risk [1]
● Product without strain code [2]
6 Interactions
Drug interactions
Antibiotics Minor
Mechanism: Antibiotics reduce Bifidobacterium populations. [2]
Effect: Reduced probiotic efficacy. [2]
Action: Separate by 2+ hours [2].
Supplement synergies
Prebiotics (FOS, GOS, HMOs) · 3–5 g/day
Selectively feed Bifidobacteria [1].
Selectively feed Bifidobacteria [1].
Lactobacillus · Multi-strain product
Complementary probiotic genera [1].
Complementary probiotic genera [1].
7 US supplement products
2
on-market products containing Bifidobacterium (NIH DSLD)
Brands carrying Bifidobacterium (2)
Click a brand to see its Bifidobacterium products.
8 Frequently paired with
9 Cite this page
Vancouver: Pkhakadze G. Bifidobacterium — safety profile [Internet]. Tbilisi: PHIG; 2026 [cited 2026 Aug 15]. Available from: https://supplement.ge/ingredients/bifidobacterium/
APA 7th: Pkhakadze, G. (2026). Bifidobacterium — Safety profile. Public Health Institute of Georgia. https://supplement.ge/ingredients/bifidobacterium/
📋 Editorial information
Author: Prof. G. Pkhakadze, MD, MPH, PhD
Institution: Public Health Institute of Georgia (PHIG)
Affiliation: David Tvildiani Medical University (DTMU)
First published: January 2026
Last reviewed: 2026-05-29
Next review: February 2027
References: 2 cited sources
COI: SupplementIndex receives no funding from supplement manufacturers. All content independently authored by PHIG.
Process: Systematic literature review
📄 License & reuse
Published under Creative Commons Attribution 4.0 International (CC BY 4.0). You may share and adapt for any purpose with attribution.
Pkhakadze G. "Bifidobacterium — Safety Profile." SupplementIndex, PHIG, 2026. https://supplement.ge/ingredients/bifidobacterium/ CC BY 4.0.
GP
Prof. G. Pkhakadze, MD, MPH, PhD
Professor of Public Health · Head of Department, DTMU
Editor-in-Chief, Georgian Medical Journal (ISSN 3088-4322)
Chair, Public Health Institute of Georgia · UEMS Public Health Section
Educational and public health purposes. CC BY 4.0. Consult your healthcare provider before starting any supplement. Corrections: info@accreditation.ge. Publisher: PHIG