What is Align?
Align is a probiotic dietary supplement containing Bifidobacterium longum subsp. infantis 35624 (also known as B. infantis 35624), marketed primarily for digestive health support.
Product Composition and Characteristics
Align contains a single strain: Bifidobacterium longum subsp. infantis 35624 at a dose typically around 10^8-10^9 CFU per capsule 1
This strain belongs to the Bifidobacterium genus, which demonstrates favorable colonization patterns in the gut and can reduce potentially pathogenic bacteria 2
B. infantis has superior ability to degrade all human milk oligosaccharide (HMO) types compared to other Bifidobacterium species, which contributes to its persistence in the gut 3
Clinical Evidence and Applications
Documented Benefits
Depression in IBS patients: B. longum NCC3001 (a related strain) reduced depression scores by ≥2 points in 64% of treated patients versus 32% in placebo (p=0.04), with associated changes in brain activation patterns on fMRI 4
Quality of life improvements in IBS patients, though anxiety and IBS symptom scores showed no significant benefit 4
Microbiome effects: B. infantis supplementation increases Bifidobacterium abundance, reduces pathogenic bacteria (particularly Gammaproteobacteria), and promotes metabolic shifts including increased short-chain fatty acid production 3
Important Limitations
Limited guideline support: The American Gastroenterological Association makes no specific recommendations for B. longum strains in IBS, suggesting probiotics only in clinical trial contexts due to heterogeneous evidence 5
Single-strain limitations: B. longum and B. infantis as single strains may have reduced fitness compared to multi-strain formulations due to limited enzymatic repertoire, though B. infantis performs better than other single Bifidobacterium strains 3
Transient effects: Some benefits may diminish after supplementation ends, though B. infantis persists better than other Bifidobacterium species 3
Critical Clinical Considerations
Testing Interference
Discontinue before lactulose breath testing: Align significantly increases methane excretion during lactulose breath tests for small intestinal bacterial overgrowth (SIBO), potentially causing false-positive results 1
Patients should stop Align at least 2 weeks before SIBO testing to avoid test interference 1
Safety Profile
Contraindications: Avoid in immunocompromised patients, those with central venous catheters, cardiac valvular disease, or short-gut syndrome due to bacteremia risk 5, 2
Generally well-tolerated in healthy individuals with no significant adverse effects reported in clinical trials 4
Regulatory Status
Align is a dietary supplement, not a pharmaceutical product, meaning it faces less stringent quality control than prescription medications 6
Product quality verification is essential, as probiotic effects are highly strain-specific and manufacturing quality varies 6, 2
Comparison to Evidence-Based Alternatives
Stronger evidence exists for other probiotic strains in specific conditions: Lactobacillus rhamnosus GG for general gut health, multi-strain formulations for ulcerative colitis/pouchitis, and B. animalis subsp. lactis for preterm neonates 6, 5, 2
Multi-strain Bifidobacterium formulations may be more effective than single strains due to metabolic cross-feeding and enhanced colonization 3
Practical Recommendations
Consider Align for patients with IBS and comorbid depression who have failed other interventions, based on the single positive RCT showing depression reduction 4
Do not expect significant anxiety reduction or IBS symptom improvement based on current evidence 4
Verify product quality by choosing pharmaceutical-grade products when available rather than standard dietary supplements 2
Set realistic expectations: Effects are strain-specific and cannot be extrapolated to other Bifidobacterium products, even within the same species 6