PMID- 31478755
OWN - NLM
STAT- MEDLINE
DCOM- 20200818
LR  - 20201101
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 29
IP  - 9
DP  - 2019 Nov
TI  - Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A 
      Placebo-Controlled Pilot Trial.
PG  - 659-669
LID - 10.1089/cap.2018.0156 [doi]
AB  - Objective: A randomized pilot trial of gastrointestinal (GI) symptoms targeting 
      probiotic for quality of life in autism spectrum disorder (ASD). Methods: 
      Thirteen children, 3-12 years of age with ASD, anxiety, and GI symptoms, were 
      randomized into a probiotic crossover trial of 8 weeks each on VISBIOME and 
      placebo separated by a 3-week washout. VISBIOME contains eight probiotic species, 
      mostly Lactobacillus and Bifidobacterium. Primary outcome was the Pediatric 
      Quality of Life Inventory (PedsQL) GI module. Secondary outcomes included gut 
      microbiota analysis, the Parent-Rated Anxiety Scale for ASD (PRAS-ASD), and 
      parent-selected target symptoms. A mixed analysis model was applied. Results: 
      Thirteen children were randomized, with 10 completing the study (77% retention): 
      6 in probiotic/placebo sequence, 4 in placebo/probiotic sequence. Adherence to 
      study treatment was 96%. There were no serious adverse events (AEs), and more 
      nonserious AEs occurred with placebo than with probiotic, including those 
      attributable to treatment. Only 6 of the 10 guessed the correct treatment at the 
      end of week 8. Over the 19-week trial, each outcome improved from baseline and 
      PedsQL correlated significantly with abundance of Lactobacillus without 
      discernable changes to microbiota composition/diversity. Although probiotic 
      showed more improvement than placebo, PedsQL and PRAS-ASD were not statistically 
      significant, as expected at this sample size. PedsQL effect size was d = 0.49 by 
      the general model and d = 0.79 by simple comparison of week 8 changes. A 
      parent-selected target symptom showed significant improvement in GI complaints on 
      probiotic compared with placebo (p = 0.02, d = 0.79). Probiotic effects carried 
      over through the 3-week washout. Conclusion: The VISBIOME formulation was safe 
      and suggested a health benefit in children with ASD and GI symptoms who retained 
      Lactobacillus. The moderate effect size compared with placebo warrants a larger 
      trial using a parallel-group design.
FAU - Arnold, L Eugene
AU  - Arnold LE
AD  - Department of Psychiatry, Ohio State University, Columbus, Ohio.
AD  - Nisonger Center, Ohio State University, Columbus, Ohio.
FAU - Luna, Ruth Ann
AU  - Luna RA
AD  - Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.
AD  - Texas Children's Microbiome Center, Department of Pathology, Texas Children's 
      Hospital, Houston, Texas.
FAU - Williams, Kent
AU  - Williams K
AD  - Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.
FAU - Chan, James
AU  - Chan J
AD  - Massachusetts General Hospital, Boston, Massachusetts.
FAU - Parker, Robert A
AU  - Parker RA
AD  - Massachusetts General Hospital, Boston, Massachusetts.
FAU - Wu, Qinglong
AU  - Wu Q
AD  - Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.
AD  - Texas Children's Microbiome Center, Department of Pathology, Texas Children's 
      Hospital, Houston, Texas.
FAU - Hollway, Jill A
AU  - Hollway JA
AD  - Department of Psychiatry, Ohio State University, Columbus, Ohio.
AD  - Nisonger Center, Ohio State University, Columbus, Ohio.
FAU - Jeffs, Adelina
AU  - Jeffs A
AD  - Department of Psychiatry, Ohio State University, Columbus, Ohio.
AD  - Nisonger Center, Ohio State University, Columbus, Ohio.
FAU - Lu, Frances
AU  - Lu F
AD  - Massachusetts General Hospital, Boston, Massachusetts.
FAU - Coury, Daniel L
AU  - Coury DL
AD  - Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.
FAU - Hayes, Caitlin
AU  - Hayes C
AD  - Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.
FAU - Savidge, Tor
AU  - Savidge T
AD  - Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.
AD  - Texas Children's Microbiome Center, Department of Pathology, Texas Children's 
      Hospital, Houston, Texas.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20190830
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Placebos)
SB  - IM
MH  - Autism Spectrum Disorder/*drug therapy
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Male
MH  - Pilot Projects
MH  - *Placebos
MH  - Probiotics/*therapeutic use
MH  - Quality of Life/*psychology
PMC - PMC7364307
OTO - NOTNLM
OT  - anxiety
OT  - autism
OT  - autism spectrum disorder
OT  - gastrointestinal problems
OT  - probiotics
OT  - quality of life
EDAT- 2019/09/04 06:00
MHDA- 2020/08/19 06:00
PMCR- 2020/11/01
CRDT- 2019/09/04 06:00
PHST- 2019/09/04 06:00 [pubmed]
PHST- 2020/08/19 06:00 [medline]
PHST- 2019/09/04 06:00 [entrez]
PHST- 2020/11/01 00:00 [pmc-release]
AID - 10.1089/cap.2018.0156 [pii]
AID - 10.1089/cap.2018.0156 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2019 Nov;29(9):659-669. doi: 
      10.1089/cap.2018.0156. Epub 2019 Aug 30.