Evidence map›Paper›PMID 28114246›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2017

Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB-12-Supplemented Yogurt in Healthy Children.

Tina P Tan, Zhaoyong Ba, Mary E Sanders, Frank J D'Amico, Robert F Roberts, Keisha H Smith, Daniel J Merenstein

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01652287 (Yogurt Beverages as a Vehicle to Deliver High Dose Probiotics), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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.

NCT01652287 phase1completednot on this map

Yogurt Beverages as a Vehicle to Deliver High Dose Probiotics

TypeinterventionalSponsorGeorgetown UniversityRan2013 to 2014Enrolled62ConditionsChildrenArmsBB-12 supplemented strawberry yogurt, Strawberry flavored yogurt
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Nutrients · 2021
    Trial
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Understanding the probiotic health benefits ofFrontiers in microbiology · 2025
    Review
  10. Administration ofmedRxiv : the preprint server for health sciences · 2023
    Article
  11. Administration ofFrontiers in microbiology · 2023
    Article
  12. Review
  13. The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2018
    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

7 authors.

Tina P Tan*Department of Family Medicine, Georgetown University Medical Center, Washington, DC†Department of Food Science, Pennsylvania State University, University Park, PA‡Dairy and Food Culture Technologies, Centennial, CO§Department of Mathematics, UPMC-St. Margaret Hospital/Duquesne University, Pittsburgh, PA.
Zhaoyong Ba
Mary E Sanders
Frank J D'Amico
Robert F Roberts
Keisha H Smith
Daniel J Merenstein

Funding

Yogurt beverages as a vehicle to deliver high dose probioticsU01AT003600 · NCCIH · GEORGETOWN UNIVERSITY · PI MERENSTEIN, DANIEL J · 2009 to 2013
$1.3M
NCCIH NIH HHS U01 AT003600
6 · The paper itself

Abstract

objectivesProbiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration has required those studies to be conducted as investigational new drugs. This phase I, double-blinded, randomized, controlled safety study represents the first requirement of this pathway. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of children. The secondary aim was to assess the effect of BB-12-supplemented yogurt on the gut microbiota of the children.

methodsSixty children ages 1 to 5 years were randomly assigned to consume 4 ounces of either BB-12-supplemented yogurt or nonsupplemented control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, as determined by the number of reported adverse events.

resultsA total of 186 nonserious adverse events were reported, with no significant differences between the control and BB-12 groups. No significant changes due to probiotic treatment were observed in the gut microbiota of the study cohort.

conclusionsBB-12-supplemented yogurt is safe and well-tolerated when consumed by healthy children. The present study will form the basis for future randomized clinical trials investigating the potential effects of BB-12-supplemented yogurt in different disease states.

Indexed as

Bifidobacterium animalisGastrointestinal MicrobiomeChild, PreschoolDouble-Blind MethodFemaleFollow-Up StudiesHealthy VolunteersHumansInfantMaleProbioticsYogurt

Identifiers

PMID28114246
PMCPMC5298889

What OpenQuestion holds

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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.