Evidence map›Paper›PMID 26382580›Full record

Trial reportThe British journal of nutrition2015

Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12®, on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial.

Dorte Eskesen, Lillian Jespersen, Birgit Michelsen, Peter J Whorwell, Stefan Müller-Lissner, Cathrine M Morberg

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The British journal of nutrition, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06959758 (Effects of Probiotics), which is not on this map. Cited by 39 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 3 pooled it
4.2field-weighted citation impact, top 6% of its field
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.

NCT06959758 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Effects of Probiotics (BioKid LR - Contains Nine Different Species of Probiotics Bacteria Including L. Reuteri) in Children With Functional Constipation: a Double Blind Randomized Control Trial

TypeinterventionalSponsorFerass Abu HannaRan2024 to 2027Enrolled80ConditionsConstipationArmsProbiotic Arm, Placebo
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Journal of microbiology and biotechnology · 2026
    Article
  10. Viable and Heat-InactivatedMicroorganisms · 2026
    Article
  11. Review
  12. Engineering microbiology · 2025
    Article
  13. Article
  14. Article
  15. Understanding the probiotic health benefits ofFrontiers in microbiology · 2025
    Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. 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 at 3 institutions in 3 countries.

Dorte Eskesen1Chr. Hansen A/S,2970 Hørsholm,Denmark.
Lillian Jespersen1Chr. Hansen A/S,2970 Hørsholm,Denmark.
Birgit Michelsen1Chr. Hansen A/S,2970 Hørsholm,Denmark.
Peter J Whorwell2Centre for Gastrointestinal Sciences,University Hospital of South Manchester,Manchester M23 9LT,UK.
Stefan Müller-Lissner3Park-Klinik Weissensee,13086 Berlin,Germany.
Cathrine M Morberg1Chr. Hansen A/S,2970 Hørsholm,Denmark.
Chr. Hansen (Denmark) · DKPark-Klinik Weißensee · DEUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of the present study was to investigate the effect of Bifidobacterium animalis subsp. lactis, BB-12®, on two primary end points - defecation frequency and gastrointestinal (GI) well-being - in healthy adults with low defecation frequency and abdominal discomfort. A total of 1248 subjects were included in a randomised, double-blind, placebo-controlled trial. After a 2-week run-in period, subjects were randomised to 1 or 10 billion colony-forming units/d of the probiotic strain BB-12® or a matching placebo capsule once daily for 4 weeks. Subjects completed a diary on bowel habits, relief of abdominal discomfort and symptoms. GI well-being, defined as global relief of abdominal discomfort, did not show significant differences. The OR for having a defecation frequency above baseline for ≥50% of the time was 1·31 (95% CI 0·98, 1·75), P=0·071, for probiotic treatment overall. Tightening the criteria for being a responder to an increase of ≥1 d/week for ≥50 % of the time resulted in an OR of 1·55 (95% CI 1·22, 1·96), P=0·0003, for treatment overall. A treatment effect on average defecation frequency was found (P=0·0065), with the frequency being significantly higher compared with placebo at all weeks for probiotic treatment overall (all P<0·05). Effects on defecation frequency were similar for the two doses tested, suggesting that a ceiling effect was reached with the one billion dose. Overall, 4 weeks' supplementation with the probiotic strain BB-12® resulted in a clinically relevant benefit on defecation frequency. The results suggest that consumption of BB-12® improves the GI health of individuals whose symptoms are not sufficiently severe to consult a doctor (ISRCTN18128385).

Indexed as

BifidobacteriumDefecationAbdominal PainAdultDouble-Blind MethodFemaleFranceGermanyHumansMaleMiddle AgedOdds RatioPatient CompliancePlacebosProbioticsSurveys and QuestionnairesPlacebosAE adverse eventsBifidobacterium animalis subsp. lactisBowel habitsDefecation frequencyGastrointestinal well-beingGI gastrointestinalIBS irritable bowel syndromeITT intention-to-treatPP per-protocolProbiotics

Identifiers

PMID26382580
PMCPMC4657032
OpenAlexW2136311124

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.