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Randomized Double-blind Clinical Trial With L.Reuteri Supplementation in Children With Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT04293783
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
University of Bari
Information provided by (Responsible Party):
Luigi Mazzone, University of Rome Tor Vergata

Brief Summary:
The aim of this study is to assess the effects of a 6-months probiotic supplementation on behavioral profiles, microbiota and metabolic profiles, inflammatory biomarkers, gastrointestinal disturbances, in children with Autism Spectrum Disorders (ASD) with or without GI symptoms.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Dietary Supplement: L.Reuteri Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind randomized, parallel-group, placebo-controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Placebo chewable caps are identical in shape and taste to the test product, without the Lactobacillus reuteri components Both study products are delivered in identical containers and labelled as XXX.
Primary Purpose: Treatment
Official Title: Efficacy of Lactobacillus Reuteri in Managing Social Deficits in Children With Autistic Spectrum Disorder: a Randomized Clinical Trial With Evaluation of Gut Microbiota and Metabolomics Profiles
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: L.Reuteri
Lactobacillus reuteri DSM 17938 + Lactobacillus reuteri ATCC PTA 6475 two tablet by mouth 1 time per day
Dietary Supplement: L.Reuteri
daily supplementation with two tablet for six months
Other Name: Gastrus

Placebo Comparator: Placebo
Placebo two tablet by mouth 1 times per day
Dietary Supplement: Placebo
daily supplementation with two tablet for six months




Primary Outcome Measures :
  1. Changes in severity level of ASD symptomatology [ Time Frame: 6 months ]
    Delta of scores at Autism Diagnostic Observation Schedule-2

  2. Changes in Microbiome Profile [ Time Frame: 3 months and 6 months ]
    Characterization of the fecal and salivary microbiota by using a metagenomic approach (amplification and sequencing of a portion of the bacterial 16S rRNA) gene. A special focus is to evaluate if there is dysbiosis, if the supplementation rescues the dysbiosis and if these changes are correlated with the gastrointestinal and behavioral symptoms


Secondary Outcome Measures :
  1. Changes in GI symptoms [ Time Frame: 3 months and 6 months ]
    Delta of scores at GSRS (Gastrointestinal Symptoms Rating Scale). Higher scores are related to greater severity of symptoms

  2. Changes in ASD symptomatology: problematic behaviors [ Time Frame: 3 months and 6 months ]
    Delta of scores at ABC (Aberrant Behavior Checklist), a 58 item scale. Higher scores are related to greater severity of symptoms

  3. Changes in ASD symptomatology: repetitive behaviors [ Time Frame: 3 months and 6 months ]
    Delta of scores at RBS-R (Repetitive Behavior Scale-Revised), a 43 item scale. Higher scores are related to greater severity of symptoms

  4. Changes in Adaptive Functioning [ Time Frame: 6 months ]
    Delta of scores at Adaptive Behavior Assessment System-II

  5. Changes in global ASD symptomatology [ Time Frame: 3 months and 6 months ]
    Delta of scores at SRS (Social Responsiveness Scale). Higher scores are related to greater severity of symptoms

  6. Changes in Behavioral Profiles [ Time Frame: 3 months and 6 months ]
    Delta of scores at CBCL (Child Behavior CheckList)

  7. Changes in Parental Stress [ Time Frame: 3 months and 6 months ]
    Delta of scores at PSI (Parenting Stress Index)

  8. Changes in Metabolomic Profile [ Time Frame: 6 months ]
    Urinary samples collected for NMR analysis. Metabolomics profiles will be directed at biochemical processes such as neurotransmitter metabolism, gastrointestinal alterations or dysbiosis, and mitochondrial dysfunction). Furthermore, the effect of probiotic administration on the metabolome will be investigated.

  9. Changes in Inflammatory Profile [ Time Frame: 6 months ]
    Blood sample collected to evaluate changes in inflammatory profile (zonulin, IL-17 profile)



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Ages Eligible for Study:   18 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Autism Spectrum Disorder (DSM-5 criteria diagnosis)

Exclusion Criteria:

  • neurological syndromes (that explain autism symptoms)
  • coeliac disease
  • other organic GI disorder
  • special diet.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293783


Contacts
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Contact: Roberta Abate, MD 3283211755 ext +39 robiabate@gmail.com
Contact: Luigi Mazzone, MD, PhD 3395969516 ext +39 gigimazzone@yahoo.it

Locations
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Italy
University of Bari Active, not recruiting
Bari, BA, Italy, 00100
University of Rome Tor Vergata Recruiting
Rome, RM, Italy, 00133
Contact: Roberta Abate, MD    3283211755 ext +39    robiabate@gmail.com   
Contact: Luigi Mazzone, MD, PhD    3395969516 ext +39    gigimazzone@yahoo.it   
Principal Investigator: Luigi Mazzone, MD, PhD         
Sub-Investigator: Roberta Abate, MD         
Sub-Investigator: Lucrezia Arturi         
Sub-Investigator: Martina Siracusano, MD         
Sponsors and Collaborators
University of Rome Tor Vergata
University of Bari
Investigators
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Principal Investigator: Mazzone Luigi, MD, PhD University of Rome Tor Vergata
Principal Investigator: Francavilla Ruggiero, MD, PhD University of Bari
Publications:

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Responsible Party: Luigi Mazzone, MD, PhD, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT04293783    
Other Study ID Numbers: Reg. Sperim. 244/19
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected IPD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: starting 6 months after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luigi Mazzone, University of Rome Tor Vergata:
Probiotic
Gut-Brain axis
L. Reuteri
Social Behavior
Microbiome
Metabolome
Inflammatory Profile
Gastrointestinal Symptoms
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders