Evidence map›Paper›PMID 16971641›Full record

Trial reportJournal of clinical microbiology2006

Effects of Bifidobacterium lactis Bb12 supplementation on intestinal microbiota of preterm infants: a double-blind, placebo-controlled, randomized study.

Ruchika Mohan, Corinna Koebnick, Janko Schildt, Sabine Schmidt, Manfred Mueller, Mike Possner, Michael Radke, Michael Blaut

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical microbiology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03434249 (Studio Clinico Randomizzato Per Valutare l'Efficacia Del Bifidobacterium BB-12® Nel Trattamento Delle Coliche Infantili), which is not on this map. Cited by 80 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 17 pooled it
6.2field-weighted citation impact, top 3% 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.

NCT03434249 nacompletednot on this mapstarted 2016, after this paper: background citation

Studio Clinico Randomizzato Per Valutare l'Efficacia Del Bifidobacterium BB-12® Nel Trattamento Delle Coliche Infantili

TypeinterventionalSponsorSOFAR S.p.A.Ran2016 to 2017Enrolled80ConditionsInfantile Colic, Colic, InfantileArmsBifidobacterium, BB-12® (Bifidolactis Infant), Bifidolactis Infant Placebo
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 17 syntheses or guidelines pooled it, 225 citations in OpenAlex.

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  2. Probiotics in infants for prevention of allergic disease.The Cochrane database of systematic reviews · 2025
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  8. Systematic Review of the Effect of Enteral Feeding on Gut Microbiota in Preterm Infants.Journal of obstetric, gynecologic, and neonatal nursing : JOGNN · 2018
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  13. A meta-analysis of probiotics for preventing necrotizing enterocolitis in preterm neonates.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2014
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20 more citing papers are in PubMed but not listed here.

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

8 authors at 3 institutions in 1 country.

Ruchika MohanDepartment of Gastrointestinal Microbiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Arthur-Scheunert-Allee 114-116, 14558 Nuthetal, Germany.
Corinna Koebnick
Janko Schildt
Sabine Schmidt
Manfred Mueller
Mike Possner
Michael Radke
Michael Blaut
Klinikum Ernst von Bergmann · DEGerman Institute of Human Nutrition · DENestlé (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The gastrointestinal microbiota of preterm infants in a neonatal intensive care unit differs from that of term infants. In particular, the colonization of preterm infants by bifidobacteria is delayed. A double-blind, placebo-controlled, randomized clinical study was performed on 69 preterm infants to investigate the role of Bifidobacterium lactis Bb12 supplementation in modifying the gut microbiota. Both culture-dependent and culture-independent approaches were used to study the gut microbiota. Bifidobacterial numbers, determined by fluorescence in situ hybridization, were significantly higher in the probiotic than in the placebo group (log(10) values per g of fecal wet weight: probiotic, 8.18 + 0.54 [standard error of the mean]; placebo, 4.82 + 0.51; P < 0.001). A similar trend for bifidobacterial numbers was also obtained with the culture-dependent method. The infants supplemented with Bb12 also had lower viable counts of Enterobacteriaceae (log(10) values of CFU per g of fecal wet weight: probiotic, 7.80 + 0.34; placebo, 9.03 + 0.35; P = 0.015) and Clostridium spp. (probiotic, 4.89 + 0.30; placebo, 5.99 + 0.32; P = 0.014) than the infants in the placebo group. Supplementation of B. lactis Bb12 did not reduce the colonization by antibiotic-resistant organisms in the study population. However, the probiotic supplementation increased the cell counts of bifidobacteria and reduced the cell counts of enterobacteria and clostridia.

Indexed as

BifidobacteriumClostridiumColony Count, MicrobialCulture MediaDouble-Blind MethodDrug Resistance, BacterialEnterobacteriaceaeFemaleHumansInfant, NewbornInfant, PrematureIn Situ Hybridization, FluorescenceIntestinesMaleProbioticsCulture Media

Identifiers

PMID16971641
PMCPMC1698302
OpenAlexW2148719195

What OpenQuestion holds

Textmetadata
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.