Safety Profile
Known Safety Concerns
- Same immunocompromised patient safety warnings as other probiotics
- Viability at expiry varies significantly between products
- Clinical evidence for specific health claims is variable
- GI gas and bloating are common initial side effects
Contraindications
- Same immunocompromised patient safety warnings as other probiotics
- Viability at expiry varies significantly between products
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Bifidobacterium bifidum is a key probiotic species of the infant and adult gut microbiome. Used in supplements for digestive health, immune support, and IBS. Well tolerated in healthy adults. Same immunocompromised patient cautions apply as with all probiotics. The clinical evidence base for most specific health claims is modest.
Biological and Chemical Classification
- Scientific Name
- Bifidobacterium bifidum
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Botanical
- Evidence consistency: High consistency across studies (100%)
- Same immunocompromised patient safety warnings as other probiotics
- Viability at expiry varies significantly between products
- Clinical evidence for specific health claims is variable
- GI gas and bloating are common initial side effects
The available scientific evidence for Bifidobacterium Bifidum indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 24 მარ 2026, 09:12
Evidence Distribution
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Observational / other LOW evidence YELLOWHuman Milk Oligosaccharide Synbiotic Alleviates Food Allergy in Mice by Modulating Gut Microbiota and Increasing Indole-3-lactic Acid Levels. ↗Chang S et al.. Human Milk Oligosaccharide Synbiotic Alleviates Food Allergy in Mice by Modulating Gut Microbiota and Increasing Indole-3-lactic Acid Levels.. J Agric Food Chem. 2026. PMID:41859771.PMID 41859771 ↗Journal J Agric Food ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41859771/
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Observational / other LOW evidence YELLOWImpact of 1,2-u03b1-L-fucosidase on pig enteric methane production and growth performance. ↗Georgaki D et al.. Impact of 1,2-u03b1-L-fucosidase on pig enteric methane production and growth performance.. Anim Microbiome. 2026. PMID:41857672.PMID 41857672 ↗Journal Anim MicrobiomeYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41857672/
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Observational / other LOW evidence YELLOWSynbiotics regulate gut microbiota-derived indole-3-acetic acid production to modulate the intestinal barrier and improve antibiotic-associated diarrhea. ↗Shan Y et al.. Synbiotics regulate gut microbiota-derived indole-3-acetic acid production to modulate the intestinal barrier and improve antibiotic-associated diarrhea.. J Dairy Sci. 2026. PMID:41850377.PMID 41850377 ↗Journal J Dairy SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41850377/
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Observational / other LOW evidence YELLOWBifidobacterium bifidum G9-1 and Quality of Life in Chronic Constipation: A Multicenter, Double-blind, Randomized Controlled Trial. ↗Misawa N et al.. Bifidobacterium bifidum G9-1 and Quality of Life in Chronic Constipation: A Multicenter, Double-blind, Randomized Controlled Trial.. Digestion. 2026. PMID:41843723.PMID 41843723 ↗Journal DigestionYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41843723/
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Observational / other LOW evidence YELLOWThe effect of short-term consumption of Bifidobacterium bifidum on the gut microbiome of obese individuals. ↗Burakova I et al.. The effect of short-term consumption of Bifidobacterium bifidum on the gut microbiome of obese individuals.. Exp Biol Med (Maywood). 2026. PMID:41809656.PMID 41809656 ↗Journal Exp Biol Med (Maywood)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41809656/
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Observational / other LOW evidence YELLOWILA-producing bifidobacterium bifidum ameliorates chronic kidney disease via AHR signaling by modulating the gut-kidney axis. ↗Hua Q et al.. ILA-producing bifidobacterium bifidum ameliorates chronic kidney disease via AHR signaling by modulating the gut-kidney axis.. Food Res Int. 2026. PMID:41794500.PMID 41794500 ↗Journal Food Res IntYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41794500/
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Observational / other LOW evidence YELLOWBioactive metabolite profiling in mixed-species probiotic yogurt. ↗Marole TA et al.. Bioactive metabolite profiling in mixed-species probiotic yogurt.. J Dairy Sci. 2026. PMID:41780866.PMID 41780866 ↗Journal J Dairy SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41780866/
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Observational / other LOW evidence YELLOWPhytochemical Profiling and Characterization of Honeydew, Cantaloupe, and Galia Melon Peel Extracts for Potential Prebiotic Activities. ↗Sameed N et al.. Phytochemical Profiling and Characterization of Honeydew, Cantaloupe, and Galia Melon Peel Extracts for Potential Prebiotic Activities.. Food Sci Nutr. 2026. PMID:41767835.PMID 41767835 ↗Journal Food Sci NutrYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41767835/
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Observational / other LOW evidence YELLOWAdvocating gut-retina connection and microbiota mediated pathways in management of age-related macular degeneration: Preclinical to clinical perspective. ↗Waghmare PV et al.. Advocating gut-retina connection and microbiota mediated pathways in management of age-related macular degeneration: Preclinical to clinical perspective.. Ageing Res Rev. 2026. PMID:41759744.PMID 41759744 ↗Journal Ageing Res RevYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41759744/
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Observational / other LOW evidence YELLOWExploring the frontier of oral nanomedicine in colorectal cancer therapy: Folate-targeted 5FU-Nisin-Selenium conjugates and probiotic-rich diets as a novel approach. ↗Derakhshan-Sefidi M et al.. Exploring the frontier of oral nanomedicine in colorectal cancer therapy: Folate-targeted 5FU-Nisin-Selenium conjugates and probiotic-rich diets as a novel approach.. Asian J Pharm Sci. 2025. PMID:41809887.PMID 41809887 ↗Journal Asian J Pharm SciYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41809887/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Bifidobacterium Bifidum. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Low classification for Bifidobacterium Bifidum
A score of 2.0 places this ingredient in the Low band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.


