Autism Spectrum DisorderNCT04293783
Randomized Double-blind Clinical Trial With L.Reuteri Supplementation in Children With Autism Spectrum Disorder
A study testing L.Reuteri in people with Autism Spectrum Disorder, run by University of Rome Tor Vergata at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- L.Reuteri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Apr 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Autism Spectrum Disorder (DSM-5 criteria diagnosis)
Who cannot join
- neurological syndromes (that explain autism symptoms)
- coeliac disease
- other organic GI disorder
- special diet.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Bari
Bari, BA, 00100
University of Rome Tor Vergata
Rome, RM, 00133
About this study
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
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.
Read the detailed description
Autism Spectrum Disorder (ASD) is a condition that includes social deficits, repetitive behaviors and language difficulties; its prevalence continues to increase worldwide, however, there are no medication for the core symptoms of this disorder. In addition to these core symptoms, children with ASD are 3.5 times more likely to suffer from gastrointestinal issues than children without developmental disorders. Moreover, GI problems have been associated with changes in the microbial communities inhabiting the gut of ASD individuals.
Studies in animal models have suggested that the gut microbes can modulate central nervous system-driven behaviors.
In 2019, a research group (Buffington et al.) found that a specific strain (L. Reuteri PTA) rescues the deficit in social interaction-induced VTA plasticity in ASD mouse, enhancing the salience and rewarding value of social stimuli.
These data support the idea that microbial therapies could ameliorate specific endophenotypes associates with ASD.
Aim of the study The aim of this pilot study is to determine the possible effects of supplementation with a specific probiotic strain (L. Reuteri ATCC PTA 6475) in ASD children on the core deficits of the disorder, the social behavior. A secondary aim is to evaluate the effects of probiotic supplementation on specific GI symptoms, and repetitive, dysfunctional behaviors, widely described in ASD children. Finally, the investigators will evaluate gut microbiota (fecal and salivary samples) and metabolomics (urinary samples) profiles differences before and after the supplementation.
Methods and participants Double blind randomized, placebo-controlled trial, with a nutritional supplement, with two parallel arms, an allocation ratio of 1:1, and a superiority framework.
The investigators aim to enroll 80 patients. A detailed informed consent will be given and and both parents will sign it before the start of the data collection.
The participants, after a first evaluation, will be divided into 2 groups; each arm will be blind randomized 1:1 to regular diet with a specific probiotic strain (L. Reuteri ATCC PTA 6475) or with placebo for 6 months.
After randomization the investigators will explain how to take the product and the first dose will be administered.
During the study the child is not allowed to take other probiotics. The type of neurologic/rehabilitation therapy ongoing at T0 cannot be changed until the study is finished.
Study Product Test product chewable tablets: 1x108 CFU Lactobacillus reuteri DSM 17938 + 1x108 CFU Lactobacillus reuteri ATCC PTA 6475 (together 2x108 CFU) Placebo chewable caps: 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. Dosing: Two tablets/cps once a day.
Assessment
At the time of enrollment, each participant will undergo a comprehensive neuropsychological and biochemical evaluation, in order to establish the baseline of the primary and secondary outcome measures. A detailed Case Record Forms (CRF) containing all data pertinent to the study will be prepared.
At T0 the investigators will also collect blood, urinary salivary and fecal sample from each participant in order to perform biochemical, microbiological and metabolomics evaluation. The parents have to fill out questionnaire about dietary habits in a 5 day-diary.
After three months from the enrollment (T1), each child will undergo a second evaluation with some clinical and biological measures.
At the end of the study, six months from baseline, the investigators will perform another complete assessment through the same clinical, biochemical and neuropsychological evaluation performed at T0, to evaluate the possible changes in (1) autism symptoms severity; (2) affective and behavioral comorbid symptoms; (3) GI symptoms; (4) plasmatic, urinary and fecal biomarkers related to abnormal intestinal/inflammatory function. At T2, urinary salivary, and fecal sample will be also collected from each participant in order to perform microbiological and metabolomics evaluation.
All children recruited will undergo the evaluation at Child Neurology and Psychiatry unit, Policlinico Tor Vergata, Rome, Italy.
- Conditions
- Autism Spectrum Disorder
- Being tested
- L.Reuteri, Placebo
- Keywords
- Probiotic, Gut-Brain axis, L. Reuteri, Social Behavior, Microbiome, Metabolome, Inflammatory Profile, Gastrointestinal Symptoms
- Medical subject headings
- Autism Spectrum Disorder, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L.ReuteriDietary supplement
Also called Gastrus
daily supplementation with two tablet for six months
PlaceboDietary supplement
daily supplementation with two tablet for six months
| Study group | Role | What they receive |
|---|---|---|
| L.Reuteri | Active comparator | Lactobacillus reuteri DSM 17938 + Lactobacillus reuteri ATCC PTA 6475 two tablet by mouth 1 time per day Receives: Dietary Supplement: L.Reuteri |
| Placebo | Placebo comparator | Placebo two tablet by mouth 1 times per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in severity level of ASD symptomatology
Delta of scores at Autism Diagnostic Observation Schedule-2
Measured: 6 months
Changes in Microbiome Profile
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
Measured: 3 months and 6 months
Secondary outcomes (9)
Changes in GI symptoms
Delta of scores at GSRS (Gastrointestinal Symptoms Rating Scale). Higher scores are related to greater severity of symptoms
Measured: 3 months and 6 months
Changes in ASD symptomatology: problematic behaviors
Delta of scores at ABC (Aberrant Behavior Checklist), a 58 item scale. Higher scores are related to greater severity of symptoms
Measured: 3 months and 6 months
Changes in ASD symptomatology: repetitive behaviors
Delta of scores at RBS-R (Repetitive Behavior Scale-Revised), a 43 item scale. Higher scores are related to greater severity of symptoms
Measured: 3 months and 6 months
Changes in Adaptive Functioning
Delta of scores at Adaptive Behavior Assessment System-II
Measured: 6 months
Changes in global ASD symptomatology
Delta of scores at SRS (Social Responsiveness Scale). Higher scores are related to greater severity of symptoms
Measured: 3 months and 6 months
Changes in Behavioral Profiles
Delta of scores at CBCL (Child Behavior CheckList)
Measured: 3 months and 6 months
Changes in Parental Stress
Delta of scores at PSI (Parenting Stress Index)
Measured: 3 months and 6 months
Changes in Metabolomic Profile
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.
Measured: 6 months
Changes in Inflammatory Profile
Blood sample collected to evaluate changes in inflammatory profile (zonulin, IL-17 profile)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Apr 2020
- Primary completion30 Oct 2020
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind randomized, parallel-group, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari
- Responsible party
- Principal investigator, Luigi Mazzone, University of Rome Tor Vergata
- Investigators
- Mazzone Luigi, MD, PhD, Principal investigator, University of Rome Tor VergataFrancavilla Ruggiero, MD, PhD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293783
- Sponsor's protocol ID
- Reg. Sperim. 244/19
- Status last verified
- Nov 2023
- First submitted
- 26 Feb 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Sgritta M, Dooling SW, Buffington SA, Momin EN, Francis MB, Britton RA, Costa-Mattioli M. Mechanisms Underlying Microbial-Mediated Changes in Social Behavior in Mouse Models of Autism Spectrum Disorder. Neuron. 2019 Jan 16;101(2):246-259.e6. doi: 10.1016/j.neuron.2018.11.018. Epub 2018 Dec 3.
PubMed 30522820Vuong HE, Yano JM, Fung TC, Hsiao EY. The Microbiome and Host Behavior. Annu Rev Neurosci. 2017 Jul 25;40:21-49. doi: 10.1146/annurev-neuro-072116-031347. Epub 2017 Mar 8.
PubMed 28301775Schieve LA, Gonzalez V, Boulet SL, Visser SN, Rice CE, Van Naarden Braun K, Boyle CA. Concurrent medical conditions and health care use and needs among children with learning and behavioral developmental disabilities, National Health Interview Survey, 2006-2010. Res Dev Disabil. 2012 Mar-Apr;33(2):467-76. doi: 10.1016/j.ridd.2011.10.008. Epub 2011 Nov 24.
PubMed 22119694Lussu M, Noto A, Masili A, Rinaldi AC, Dessi A, De Angelis M, De Giacomo A, Fanos V, Atzori L, Francavilla R. The urinary 1 H-NMR metabolomics profile of an italian autistic children population and their unaffected siblings. Autism Res. 2017 Jun;10(6):1058-1066. doi: 10.1002/aur.1748. Epub 2017 Mar 11.
PubMed 28296209Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367.
PubMed 24424513Mazzone L, Dooling SW, Volpe E, Uljarevic M, Waters JL, Sabatini A, Arturi L, Abate R, Riccioni A, Siracusano M, Pereira M, Engstrand L, Cristofori F, Adduce D, Francavilla R, Costa-Mattioli M, Hardan AY. Precision microbial intervention improves social behavior but not autism severity: A pilot double-blind randomized placebo-controlled trial. Cell Host Microbe. 2024 Jan 10;32(1):106-116.e6. doi: 10.1016/j.chom.2023.11.021. Epub 2023 Dec 18.
PubMed 38113884
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04293783
- Acronym / sponsor ID
- Reg. Sperim. 244/19
- Conditions
- Autism Spectrum Disorder
- Keywords
- Probiotic, Gut-Brain axis, L. Reuteri, Social Behavior, Microbiome, Metabolome, Inflammatory Profile, Gastrointestinal Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Collaborators
- University of Bari
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autism Spectrum Disorder (ASD) is a condition that includes social deficits, repetitive behaviors and language difficulties; its prevalence continues to increase worldwide, however, there are no medication for the core symptoms of this disorder. In addition to these core symptoms, children with ASD are 3.5 times more likely to suffer from gastrointestinal issues than children without developmental disorders. Moreover, GI problems have been associated with changes in the microbial communities inhabiting the gut of ASD individuals.
Studies in animal models have suggested that the gut microbes can modulate central nervous system-driven behaviors.
In 2019, a research group (Buffington et al.) found that a specific strain (L. Reuteri PTA) rescues the deficit in social interaction-induced VTA plasticity in ASD mouse, enhancing the salience and rewarding value of social stimuli.
These data support the idea that microbial therapies could ameliorate specific endophenotypes associates with ASD.
Aim of the study The aim of this pilot study is to determine the possible effects of supplementation with a specific probiotic strain (L. Reuteri ATCC PTA 6475) in ASD children on the core deficits of the disorder, the social behavior. A secondary aim is to evaluate the effects of probiotic supplementation on specific GI symptoms, and repetitive, dysfunctional behaviors, widely described in ASD children. Finally, the investigators will evaluate gut microbiota (fecal and salivary samples) and metabolomics (urinary samples) profiles differences before and after the supplementation.
Methods and participants Double blind randomized, placebo-controlled trial, with a nutritional supplement, with two parallel arms, an allocation ratio of 1:1, and a superiority framework.
The investigators aim to enroll 80 patients. A detailed informed consent will be given and and both parents will sign it before the start of the data collection.
The participants, after a first evaluation, will be divided into 2 groups; each arm will be blind randomized 1:1 to regular diet with a specific probiotic strain (L. Reuteri ATCC PTA 6475) or with placebo for 6 months.
After randomization the investigators will explain how to take the product and the first dose will be administered.
During the study the child is not allowed to take other probiotics. The type of neurologic/rehabilitation therapy ongoing at T0 cannot be changed until the study is finished.
Study Product Test product chewable tablets: 1x108 CFU Lactobacillus reuteri DSM 17938 + 1x108 CFU Lactobacillus reuteri ATCC PTA 6475 (together 2x108 CFU) Placebo chewable caps: 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. Dosing: Two tablets/cps once a day.
Assessment
At the time of enrollment, each participant will undergo a comprehensive neuropsychological and biochemical evaluation, in order to establish the baseline of the primary and secondary outcome measures. A detailed Case Record Forms (CRF) containing all data pertinent to the study will be prepared.
At T0 the investigators will also collect blood, urinary salivary and fecal sample from each participant in order to perform biochemical, microbiological and metabolomics evaluation. The parents have to fill out questionnaire about dietary habits in a 5 day-diary.
After three months from the enrollment (T1), each child will undergo a second evaluation with some clinical and biological measures.
At the end of the study, six months from baseline, the investigators will perform another complete assessment through the same clinical, biochemical and neuropsychological evaluation performed at T0, to evaluate the possible changes in (1) autism symptoms severity; (2) affective and behavioral comorbid symptoms; (3) GI symptoms; (4) plasmatic, urinary and fecal biomarkers related to abnormal intestinal/inflammatory function. At T2, urinary salivary, and fecal sample will be also collected from each participant in order to perform microbiological and metabolomics evaluation.
All children recruited will undergo the evaluation at Child Neurology and Psychiatry unit, Policlinico Tor Vergata, Rome, Italy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double-blind randomized, parallel-group, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| L.Reuteri | Active comparator | Dietary Supplement: L.ReuteriLactobacillus reuteri DSM 17938 + Lactobacillus reuteri ATCC PTA 6475 two tablet by mouth 1 time per day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo two tablet by mouth 1 times per day |
Who may qualify
- Ages
- 18 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Autism Spectrum Disorder (DSM-5 criteria diagnosis)
Key exclusion criteria (4 listed)
- neurological syndromes (that explain autism symptoms)
- coeliac disease
- other organic GI disorder
- special diet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L.ReuteriAlso: Gastrusdaily supplementation with two tablet for six months | Dietary supplement | L.Reuteri |
| Placebodaily supplementation with two tablet for six months | Dietary supplement | Placebo |
Primary outcome
Changes in severity level of ASD symptomatology
Time frame: 6 months
Delta of scores at Autism Diagnostic Observation Schedule-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
9 secondary outcomes
Changes in GI symptoms
Time frame: 3 months and 6 months
Changes in ASD symptomatology: problematic behaviors
Time frame: 3 months and 6 months
Changes in ASD symptomatology: repetitive behaviors
Time frame: 3 months and 6 months
Changes in Adaptive Functioning
Time frame: 6 months
Changes in global ASD symptomatology
Time frame: 3 months and 6 months
Changes in Behavioral Profiles
Time frame: 3 months and 6 months
Changes in Parental Stress
Time frame: 3 months and 6 months
Changes in Metabolomic Profile
Time frame: 6 months
Changes in Inflammatory Profile
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 30522820Sgritta M, Dooling SW, Buffington SA, Momin EN, Francis MB, Britton RA, Costa-Mattioli M. Mechanisms Underlying Microbial-Mediated Changes in Social Behavior in Mouse Models of Autism Spectrum Disorder. Neuron. 2019 Jan 16;101(2):246-259.e6. doi: 10.1016/j.neuron.2018.11.018. Epub 2018 Dec 3.
- Background: PubMed 28301775Vuong HE, Yano JM, Fung TC, Hsiao EY. The Microbiome and Host Behavior. Annu Rev Neurosci. 2017 Jul 25;40:21-49. doi: 10.1146/annurev-neuro-072116-031347. Epub 2017 Mar 8.
- Background: PubMed 22119694Schieve LA, Gonzalez V, Boulet SL, Visser SN, Rice CE, Van Naarden Braun K, Boyle CA. Concurrent medical conditions and health care use and needs among children with learning and behavioral developmental disabilities, National Health Interview Survey, 2006-2010. Res Dev Disabil. 2012 Mar-Apr;33(2):467-76. doi: 10.1016/j.ridd.2011.10.008. Epub 2011 Nov 24.
- Background: PubMed 28296209Lussu M, Noto A, Masili A, Rinaldi AC, Dessi A, De Angelis M, De Giacomo A, Fanos V, Atzori L, Francavilla R. The urinary 1 H-NMR metabolomics profile of an italian autistic children population and their unaffected siblings. Autism Res. 2017 Jun;10(6):1058-1066. doi: 10.1002/aur.1748. Epub 2017 Mar 11.
- Background: PubMed 24424513Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367.
- Derived from this study: PubMed 38113884Mazzone L, Dooling SW, Volpe E, Uljarevic M, Waters JL, Sabatini A, Arturi L, Abate R, Riccioni A, Siracusano M, Pereira M, Engstrand L, Cristofori F, Adduce D, Francavilla R, Costa-Mattioli M, Hardan AY. Precision microbial intervention improves social behavior but not autism severity: A pilot double-blind randomized placebo-controlled trial. Cell Host Microbe. 2024 Jan 10;32(1):106-116.e6. doi: 10.1016/j.chom.2023.11.021. Epub 2023 Dec 18.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazzone Luigi, MD, PhD principal investigator
University of Rome Tor Vergata
Francavilla Ruggiero, MD, PhD principal investigator
University of Bari
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L.Reuteri in people with Autism Spectrum Disorder, run by University of Rome Tor Vergata at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in severity level of ASD symptomatology (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293783, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.