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Bla6.0
B. lactis (BB-12 / HN019) – Forschung
Überwiegend Mechanismus / Beobachtung
30 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu B. lactis (BB-12 / HN019) sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus hochwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2000–2026 mit einer typischen Studiengröße von 80 Teilnehmenden.
Basierend auf 30 Studien · 4 Meta-Analysen · 17 RCTs · 3,098 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Digestive symptoms & gut microbiotaSchnellere Darmpassage (Stunden, radiographisch messbar) und ein geringer Anstieg der Stuhlfrequenz bei Personen mit niedriger Ausgangsfrequenz — die zitierten Quellen berichten ein Odds Ratio für den Responder-Status und einen signifikanten Effekt auf die durchschnittliche Defäkationsfrequenz, jedoch keinen Wert pro Woche, und die ausschließlich auf B. lactis bezogene gepoolte Schätzung war nicht signifikant (WMD 1.34, 95% CI -0.27 bis 2.94). Kein Effekt auf Blähungen oder Bauchschmerzen · 2 Wochen
Überwiegend Mechanismus / Beobachtung13 Studien
Gut transit & bowel regularitySchnellere Darmpassage (Stunden, radiographisch messbar) und ein geringer Anstieg der Stuhlfrequenz bei Personen mit niedriger Ausgangsfrequenz — die zitierten Quellen berichten ein Odds Ratio für den Responder-Status und einen signifikanten Effekt auf die durchschnittliche Defäkationsfrequenz, jedoch keinen Wert pro Woche, und die ausschließlich auf B. lactis bezogene gepoolte Schätzung war nicht signifikant (WMD 1.34, 95% CI -0.27 bis 2.94). Kein Effekt auf Blähungen oder Bauchschmerzen · 2 Wochen
Überwiegend Mechanismus / Beobachtung12 Studien
ConstipationSchnellere Darmpassage (Stunden, radiographisch messbar) und ein geringer Anstieg der Stuhlfrequenz bei Personen mit niedriger Ausgangsfrequenz — die zitierten Quellen berichten ein Odds Ratio für den Responder-Status und einen signifikanten Effekt auf die durchschnittliche Defäkationsfrequenz, jedoch keinen Wert pro Woche, und die ausschließlich auf B. lactis bezogene gepoolte Schätzung war nicht signifikant (WMD 1.34, 95% CI -0.27 bis 2.94). Kein Effekt auf Blähungen oder Bauchschmerzen · 2 Wochen
Überwiegend Mechanismus / Beobachtung6 Studien
Immune functionVerbesserte Immunzellmarker bei älteren Menschen, wobei es sich hierbei um Laborbiomarker handelt und keine Studie eine tatsächliche Verringerung von Infektionen zeigt · 3-6 Wochen
Überwiegend Mechanismus / Beobachtung6 Studien
Diarrhoea & enteric infection
Überwiegend Mechanismus / Beobachtung5 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung4 Studien
Inflammation
Zu wenige bewertete Studien1 Studie
Aktives Forschungsgebiet
17 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2022
200020132026
1RCTn=229 · medium study2024
Einfach gesagt: The largest and best-controlled trial of this strain for constipation was null, and the authors explicitly stated it did not confirm earlier positive results.
Cheng J et al. · JAMA Netw Open (2024)
Primary outcome (change in complete spontaneous bowel movements per week): +0.80 with HN019 vs +0.66 placebo — no difference
Triple-blind across 5 hospitals, 8 weeks, Rome III functional constipation
Dose 7.0 billion CFU/day falling to 4.69 billion at end of study
Einfach gesagt: The largest trial of this strain missed one co-primary endpoint and its pre-specified responder threshold, though average defecation frequency did exceed placebo.
Eskesen D et al. · Br J Nutr (2015)
Co-primary GI well-being endpoint (global relief of abdominal discomfort): not significant
Co-primary responder analysis: OR 1.31 (95% CI 0.98-1.75, p=0.071) — missed significance
A stricter responder definition did reach significance: OR 1.55 (95% CI 1.22-1.96, p=0.0003)
Agustina R, Ekawidyani KR, Mutiyani M, Prafiantini E, Nindya TS, Damayanti W, Rejeki PS, Djuari L, Huriyati E, Bines JE, Juffrie M. · BMJ open (2025)
The secondary outcomes will include changes in secretory IgA specific to SARS-CoV-2 titre concentrations, monoclonal antibodies against SARS-CoV-2 spike protein, gut microbiota diversity and the score of Healthy Eating Index 2015.
Ethics and dissemination The study protocol was approved by the Ethics Committee of the Faculty of Medicine, Universitas Indonesia-Cipto Mangunkusumo Hospital (KET 763/UN2.F1/ETIK/PPM.00.02/2022: 1 August 2022).
The study results will be disseminated in open-access international journals, scientific meetings and conferences with stakeholders.
Einfach gesagt: Probiotics supplementation with Ritalin may have some beneficial effects among ADHD children and adolescents, such as improving auditory response control and total score of CPRS.
Sangsefidi ZS et al. · Nutritional neuroscience (2025)
This study showed a significant decrease in the CPRS total score after 4 weeks of intervention in the probiotic group (baseline: 43.96 ± 21.52; fourth week: 37.22 ± 23.01; p = 0.01).
Moreover, at the end of the study, a significant increase was observed in score of auditory response control in the probiotic versus the placebo group (probiotic: 91.55 ± 16.69; placebo: 80.55 ± 17.43; p = 0.02).
Probiotics supplementation with Ritalin may have some beneficial effects among ADHD children and adolescents, such as improving auditory response control and total score of CPRS.
Ye M, Xu X, Huang W, Du X, Liu Y, Yang G. · Frontiers in nutrition (2026)
For AOM incidence, only CBA-L74 (OR = 0.27, 95% CI: 0.11-0.68; SUCRA = 89.3%) and SS-K12 (OR = 0.44, 95% CI: 0.20-0.94; SUCRA = 71.8%) achieved statistically significant reductions vs. placebo.
Sensitivity analyses excluding two high risk-of-bias trials showed that SS-K12's effect was substantially attenuated and lost significance, whereas CBA-L74 remained robustly effective (OR = 0.28, 95% CI: 0.14-0.56).
For antibiotic prescription rates, Multi-strain (OR = 0.45; SUCRA = 87.1%) and LGG (OR = 0.69; SUCRA = 65.3%) demonstrated significant reductions; both were superior to SS-K12 in direct pairwise comparisons.
Alikamali M, Mohammad-Alizadeh-Charandabi S, Mirghafourvand M, Gharehbaghi MM, Homayouni-Rad A, Fardiazar Z, Shahnazi M. · BMJ open (2024)
Modified intention-to-treat analyses will be employed for the primary and secondary outcomes, excluding participants lost to follow-up from all postintervention assessments.
Ethics and dissemination This study protocol has been approved by the Medical University of Tabriz Ethics Committee (IR.TBZMED.REC.1401.735).
Findings will be disseminated through publication in a peer-reviewed journal and presentations at relevant conferences.
Einfach gesagt: Pooling 30 probiotic RCTs, Bifidobacterium lactis was one of the few organisms with a significant effect on stool frequency — directly contradicting an earlier meta-analysis.
van der Schoot A et al. · Clin Nutr (2022)
Response to probiotic treatment 369/647 (57%) vs 252/567 (44%) control — RR 1.28 (95% CI 1.07-1.52, p=0.007)
Probiotics increased stool frequency overall (SMD 0.71, 95% CI 0.37-1.04, p<0.00001), with Bifidobacterium lactis specifically showing a significant effect
Probiotic mixtures, Bacillus coagulans Unique IS2 and Lactobacillus casei Shirota did NOT show a significant frequency effect
Einfach gesagt: Pooled species-level data show more frequent bowel movements and faster transit in short courses, but no improvement in abdominal pain or bloating.
Araújo MM et al. · Nutr Rev (2022)
Defecation frequency: SMD 0.26 (95% CI 0.13-0.39) in healthy adults
Colonic transit time reduced only in the 14-days-or-less subgroup: SMD -0.34 (95% CI -0.62 to -0.07)
Stool consistency improved (SMD 0.76) but only in individuals WITHOUT GI symptoms
Einfach gesagt: 624 children aged 1-4 were followed for a year on prebiotic-plus-HN019 milk; the diarrhoea primary outcome was null, though respiratory and febrile morbidity fell.
Sazawal S et al. · PLoS One (2010)
PRIMARY DIARRHOEA OUTCOME NULL: 6% reduction (95% CI -1 to 12%, p=0.08)
Dysentery episodes reduced 21% (95% CI 0 to 38%, p=0.05); pneumonia 24% (95% CI 0 to 42%, p=0.05); severe acute lower respiratory infection 35% (95% CI 0 to 58%, p=0.05)
Days with severe illness reduced 16% (95% CI 5 to 26%, p=0.004) and days with high fever 5% (95% CI 0 to 10%, p=0.05)
Einfach gesagt: The significance of our study is in simultaneously assessing the effect of BB-12, alone and in different delivery vehicles, on the gut transit time, fecal short-chain fatty acids, and the composition of the gut microbiota of the study cohort.
Ba Z et al. · mSphere (2021)
Participants had significantly higher percentage of Streptococcus after consuming YS versus CAP (P = 0.01).
Bifidobacterium-specific terminal restriction fragment length polymorphism analysis revealed a significantly higher percentage of B. animalis after consuming PRE and POST compared to baseline, YS, CAP, and final washout (P < 0.0001).
In addition to fermented dairy products, many new probiotic-containing alternatives such as probiotic-containing juice, probiotic-containing chocolate, and capsules have been developed.
Einfach gesagt: To fully realize their therapeutic promise, future research must pursue large-scale, head-to-head clinical trials, integrate multiomics and precision-design approaches, and establish standardized frameworks for safety monitoring and personalized formulation.
Vergara Nieto ÁA, Diaz AH, Millán MH, Sagredo D, Gacitua JA. · The Journal of nutritional biochemistry (2026)
Probiotics exert strain-specific, multimechanistic benefits on gut barrier integrity, neuroendocrine signaling, and cardiometabolic regulation.
To fully realize their therapeutic promise, future research must pursue large-scale, head-to-head clinical trials, integrate multiomics and precision-design approaches, and establish standardized frameworks for safety monitoring and personalized formulation.
Einfach gesagt: Clinical studies have demonstrated the safety and beneficial effects of BB-12 in infants and children across multiple disorders and highlight the need for improved clinical and regulatory guidelines.
Bueno CPAR, Domínguez AC, Guyonnet D, Pouteau E. · Frontiers in microbiology (2026)
Bifidobacteria-dominance in infancy is considered protective as they not only display both anti-inflammatory and immunomodulatory effects but also foster the establishment of other beneficial species via cross-feeding interactions.
As predominance of bifidobacteria is considered the marker of a healthy breastfed infant, the use of bifidobacteria-based probiotics for the prevention of gut dysbiosis and related conditions has been investigated.
Clinical studies have demonstrated the safety and beneficial effects of BB-12 in infants and children across multiple disorders and highlight the need for improved clinical and regulatory guidelines.
Einfach gesagt: Collectively, the well documented clinical efficacies demonstrated by BB-12 are most likely not through one single mechanism, but through the collective direct and indirect effects the strain has on both its environment and the host.
Collins FWJ, Vera-Jiménez NI, Wellejus A. · Frontiers in microbiology (2025)
The BB-12 Bifidobacterium animalis subsp. lactis strain is one of the most documented probiotic strains on the market and has been shown to be effective in alleviating symptoms of a low defecation frequency and infant colic, among others.
In this review, we examine the wide range of preclinical and clinical data available for the strain, to help elucidate some of its potential mechanisms of action.
We describe the defence mechanisms developed by the strain to ensure gastrointestinal survival and transit, as well as the current knowledge on how BB-12 interacts with the host epithelial lining and cells of the immune system and the relationship between the strain and the gut microbiota.
Einfach gesagt: From our data, synbiotic supplementation showed a subtle benefit in gut functioning in apparently healthy community-dwelling elders.
Valentini Neto J et al. · Arquivos de gastroenterologia (2020)
From our data, synbiotic supplementation showed a subtle benefit in gut functioning in apparently healthy community-dwelling elders.
Our findings can suggest that the benefits in healthy individuals were less expressive than the ones presented in studies with individuals previously diagnosed as dysbiosis.
Future studies, comparing elders with and without gut dysbiosis can confirm our findings.