Evidence map›Paper›PMID 40892162›Full record

SynthesisProbiotics and antimicrobial proteins2026

Safety of One of the Most Commonly Used Probiotic Strains: Systematic Review and Meta-analysis of Reported Adverse Events.

Aneesha Kumar, Daniel Merenstein, Tina Tan, Peggy-Ita Obeng-Nyarkoh, Iva Hojsak, Frank D'Amico

Abstract readSystematic ReviewMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Probiotics and antimicrobial proteins, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Aneesha KumarDepartment of Family Medicine, Georgetown University School of Medicine, 4000 Reservoir Rd. NW Building D Room 281, Washington, DC, 20007, USA. agk55@georgetown.edu.
Daniel MerensteinDepartment of Family Medicine, Georgetown University School of Medicine, 4000 Reservoir Rd. NW Building D Room 281, Washington, DC, 20007, USA.
Tina TanDepartment of Family Medicine, Georgetown University School of Medicine, 4000 Reservoir Rd. NW Building D Room 281, Washington, DC, 20007, USA.
Peggy-Ita Obeng-NyarkohGraduate School of Arts and Sciences, Georgetown University, Washington, DC, USA.
Iva HojsakReferral Center for Pediatric Gastroenterology and Nutrition, Children's Hospital Zagreb, Zagreb, Croatia.
Frank D'AmicoDirector of Research, UPMC-St. Margaret Hospital Family Medicine, Pittsburgh, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Probiotics are widely used in everyday foods and supplements but very few studies have thoroughly evaluated safety. We evaluated adverse events (AEs) for one of the most widely used strains, Bifidobacterium animalis subsp. lactis (BB-12). A systematic review (SR) and meta-analysis (MA) were conducted to evaluate adverse events in human trials using BB-12. Two independent reviewers separately searched for randomized controlled trials (RCTs) using the following mesh words for inclusion: English language, double-blinded, randomized or random allocation, and placebo-controlled trial of BB-12. One hundred and eighty-one studies were identified of which 35 qualified for inclusion. All authors of the 35 studies were contacted to perform an individual patient data meta-analysis (IPDMA). Results from the MA studies showed there was no statistical difference in the rates of AE between the probiotic (15.2%) and placebo (14%) groups, odds ratio = 1.10, 95% confidence interval (0.88, 1.36), p = .40. Further, results from the IPDMA showed statistically similar unadjusted (27% vs. 25%) and adjusted rates of AE (43% vs. 41%) between BB-12 and placebo, with the relative risk of AE being 1.05, 95% confidence interval (.94, 1.15). Both meta-analysis approaches showed no difference in the rates of AE for the BB-12 and placebo groups. The data support the safety of wide usage of BB-12. However, half of the RCTs analyzed for the MA did not report AE data. This is a major limitation of published literature. This study has been registered in PROSPERO: https://www.crd.york.ac.uk/PROSPERO/view/CRD42023434556.

Indexed as

Bifidobacterium animalisProbioticsHumansRandomized Controlled Trials as TopicAdverse eventBifidobacteriumHuman probiotic interventionIndividual patient data meta-analysisMeta-analysis

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.