Evidence map›Paper›PMID 30625189›Full record

Trial reportPloS one2019

Pilot study of probiotic/colostrum supplementation on gut function in children with autism and gastrointestinal symptoms.

Megan R Sanctuary, Jennifer N Kain, Shin Yu Chen, Karen Kalanetra, Danielle G Lemay, Destanie R Rose, Houa T Yang, Daniel J Tancredi, J Bruce German, Carolyn M Slupsky and 4 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 116 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
116citing papers in PubMed, 14 pooled it
15.9field-weighted citation impact, top 1% 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.

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

116 citing papers in PubMed, 14 syntheses or guidelines pooled it, 242 citations in OpenAlex.

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  2. Complementary and Alternative Medicine for Autism - A Systematic Review.Journal of autism and developmental disorders · 2025
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56 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

14 authors at 2 institutions in 1 country.

Megan R SanctuaryDepartment of Nutrition, University of California, Davis, California, United States of America.
Jennifer N KainDepartment of Neurobiology, Physiology and Behavior, University of California, Davis, California, United States of America.
Shin Yu ChenDepartment of Food Science and Technology, University of California, Davis, California, United States of America.
Karen KalanetraDepartment of Food Science and Technology, University of California, Davis, California, United States of America.
Danielle G LemayUSDA ARS Western Human Nutrition Research Center, Davis, California, United States of America.
Destanie R RoseMIND Institute, University of California Davis, Sacramento, California, United States of America.
Houa T YangMIND Institute, University of California Davis, Sacramento, California, United States of America.
Daniel J TancrediDepartment of Pediatrics, University of California School of Medicine, Sacramento, California, United States of America.ORCID 0000-0002-3884-7907
J Bruce GermanDepartment of Food Science and Technology, University of California, Davis, California, United States of America.
Carolyn M SlupskyDepartment of Nutrition, University of California, Davis, California, United States of America.
Paul AshwoodMIND Institute, University of California Davis, Sacramento, California, United States of America.
David A MillsDepartment of Food Science and Technology, University of California, Davis, California, United States of America.
Jennifer T SmilowitzDepartment of Food Science and Technology, University of California, Davis, California, United States of America.
Kathleen AngkustsiriMIND Institute, University of California Davis, Sacramento, California, United States of America.ORCID 0000-0001-9769-6638
University of California, Davis · USWestern Human Nutrition Research Center · US

Funding

UC DAVIS CLINICAL AND TRANSLATIONAL SCIENCE CENTER: BPCAUL1RR024146 · NCRR · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2006 to 2011
$27.0M
UC Davis Clinical and Translational Science CenterUL1TR000002 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2012 to 2015
$12.2M
Rodent Behavior CoreU54HD079125 · NICHD · UNIVERSITY OF CALIFORNIA AT DAVIS · PI SIMON, TONY J · 2013 to 2019
$8.5M
Activation of probiotic bifidobacteria by milk glyansR01AT008759 · NCCIH · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GERMAN, BRUCE, LEBRILLA, CARLITO B · 2014 to 2018
$4.2M
Immune regulation and gastrointestinal co-morbidity in autism spectrum disordersR01HD090214 · NICHD · UNIVERSITY OF CALIFORNIA AT DAVIS · PI ASHWOOD, PAUL · 2018 to 2022
$1.9M
UC Davis Clinical and Translational Science CenterTL1TR000133 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2012 to 2015
$594k
The effects of environmental air pollutants on maternal allergic asthma and its neurobiological consequencesR21ES025560 · NIEHS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI ASHWOOD, PAUL · 2017 to 2018
$432k
NCATS NIH HHS TL1 TR000133NCATS NIH HHS UL1 TR000002NCCIH NIH HHS R01 AT008759NCRR NIH HHS UL1 RR024146NICHD NIH HHS U54 HD079125
6 · The paper itself

Abstract

Over half of all children with autism spectrum disorders (ASD) have gastrointestinal (GI) co-morbidities including chronic constipation, diarrhea, and irritable bowel syndrome. The severity of these symptoms has been correlated with the degree of GI microbial dysbiosis. The study objective was to assess tolerability of a probiotic (Bifidobacterium infantis) in combination with a bovine colostrum product (BCP) as a source of prebiotic oligosaccharides and to evaluate GI, microbiome and immune factors in children with ASD and GI co-morbidities. This pilot study is a randomized, double blind, controlled trial of combination treatment (BCP + B. infantis) vs. BCP alone in a cross-over study in children ages 2-11 with ASD and GI co-morbidities (n = 8). This 12-week study included 5 weeks of probiotic-prebiotic supplementation, followed by a two-week washout period, and 5 weeks of prebiotic only supplementation. The primary outcome of tolerability was assessed using validated questionnaires of GI function and atypical behaviors, along with side effects. Results suggest that the combination treatment is well-tolerated in this cohort. The most common side effect was mild gassiness. Some participants on both treatments saw a reduction in the frequency of certain GI symptoms, as well as reduced occurrence of particular aberrant behaviors. Improvement may be explained by a reduction in IL-13 and TNF-α production in some participants. Although limited conclusions can be drawn from this small pilot study, the results support the need for further research into the efficacy of these treatments.

Indexed as

ColostrumAnimalsAutistic DisorderCattleChildChild, PreschoolDouble-Blind MethodFemaleGastrointestinal DiseasesHumansInterleukin-13MalePrebioticsProbioticsTumor Necrosis Factor-alphaInterleukin-13PrebioticsTumor Necrosis Factor-alpha

Identifiers

PMID30625189
PMCPMC6326569
OpenAlexW2910432094

What OpenQuestion holds

Textmetadata
LicenceCC0
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.