Evidence map›Paper›PMID 27449926›Full record

Trial reportTrials2016

Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial.

Smita Awasthi, Reason Wilken, Forum Patel, J Bruce German, David A Mills, Carlito B Lebrilla, Kyoungmi Kim, Samara L Freeman, Jennifer T Smilowitz, April W Armstrong and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02286999 (A Parallel-group, Randomized, Placebo-controlled Ascending Dose Phase I Study Protocol for Dietary Supplementation With Bifidobacterium Longum Subsp. Infantis), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.7field-weighted citation impact, top 14% 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.

NCT02286999 phase1withdrawnnot on this map

A Parallel-group, Randomized, Placebo-controlled Ascending Dose Phase I Study Protocol for Dietary Supplementation With Bifidobacterium Longum Subsp. Infantis (B. Infantis) in Healthy Breastfed Infants

TypeinterventionalSponsorEmanual Maverakis, MDRan2015 to 2018Enrolled0ConditionsAtopic Dermatitis, Food AllergiesArmsB. infantis, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

11 authors at 3 institutions in 1 country.

Smita AwasthiDepartment of Dermatology, University of California Davis Medical Center, Sacramento, CA, USA.
Reason WilkenDepartment of Dermatology, University of California Davis Medical Center, Sacramento, CA, USA.
Forum PatelDepartment of Dermatology, University of California Davis Medical Center, Sacramento, CA, USA.
J Bruce GermanDepartment of Food Science & Technology, University of California Davis , Davis, CA, USA.
David A MillsDepartment of Food Science & Technology, University of California Davis , Davis, CA, USA.
Carlito B LebrillaDepartment of Chemistry, University of California Davis , Davis, CA, USA.
Kyoungmi KimDivision of Biostatistics, Department of Public Health Sciences, University of California Davis , Davis, CA, USA.
Samara L FreemanFoods for Health Institute, University of California Davis , Davis, CA, USA.
Jennifer T SmilowitzFoods for Health Institute, University of California Davis , Davis, CA, USA.
April W ArmstrongDepartment of Dermatology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA.
Emanual MaverakisDepartment of Dermatology, University of California Davis Medical Center, Sacramento, CA, USA. emaverakis@ucdavis.edu.
University of California, Davis · USUniversity of California Davis Medical Center · USUniversity of Southern California · US

Funding

Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
NCI NIH HHS P30 CA093373
6 · The paper itself

Abstract

backgroundThe development of probiotics as therapies to cure or prevent disease lags far behind that of other investigational medications. Rigorously designed phase I clinical trials are nearly non-existent in the field of probiotic research, which is a contributing factor to this disparity. As a consequence, how to appropriately dose probiotics to study their efficacy is unknown. Herein we propose a novel phase I ascending dose trial of Bifidobacterium longum subsp. infantis (B. infantis) to identify the dose required to produce predominant gut colonisation in healthy breastfed infants at 6 weeks of age. METHODS/

designThis is a parallel-group, placebo-controlled, randomised, double-blind ascending dose phase I clinical trial of dietary supplementation with B. infantis in healthy breastfed infants. The objective is to determine the pharmacologically effective dose (ED) of B. infantis required to produce predominant (>50 %) gut colonisation in breastfed infants at 6 weeks of age. Successively enrolled infant groups will be randomised to receive two doses of either B. infantis or placebo on days 7 and 14 of life. Stool samples will be used to characterise the gut microbiota at increasing doses of B. infantis. DISCUSSION: Probiotic supplementation has shown promising results for the treatment of a variety of ailments, but evidence-based dosing regimes are currently lacking. The ultimate goal of this trial is to establish a recommended starting dose of B. infantis for further efficacy-testing phase II trials designed to evaluate B. infantis for the prevention of atopic dermatitis and food allergies in at-risk children.

trial registrationClinicaltrials.gov # NCT02286999 , date of trial registration 23 October 2014.

Indexed as

Breast FeedingGastrointestinal MicrobiomeAge FactorsBifidobacterium longum subspecies infantisCaliforniaClinical ProtocolsDouble-Blind MethodFecesFemaleGastrointestinal TractHumansInfantInfant, NewbornMaleProbioticsResearch DesignAtopic dermatitisAtopyBifidobacterium infantisDose-escalationFood allergyPhase I clinical trialProbiotic

Identifiers

PMID27449926
PMCPMC4957407
OpenAlexW2487168627

What OpenQuestion holds

Textmetadata
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.