NCT03337035

Probiotics and Oxytocin Nasal Spray on Social Behaviors of Autism Spectrum Disorder (ASD) Children

Completed Phase 1 Last updated 4 March 2020

What this trial tests

Phase 1 trial testing intranasal oxytocin in Autism Spectrum Disorder in 35 participants. Completed in 2 October 2019.

Timeline

1 December 2018

Primary endpoint
2 October 2019

2 October 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	35
Start date	1 December 2018
Primary completion	2 October 2019
Estimated completion	2 October 2019
Sites	1 location across United States

Drugs / interventions tested

• intranasal oxytocin — full drug profile →
• oral probiotics
• oral placebo

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Massachusetts General Hospital

Who can join

Adults 3 to 25, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Because oral probiotics reported to potentially induce endogenous Oxytocin, and Oxytocin has been reported to improve social behaviors, the investigators will conduct a pilot trial to compare the effects of probiotics and Oxytocin on social behavioral changes in ASD children. Additionally, the investigators will check oxytocin levels, and perform brain fMRI in some subjects, in order to determine which treatment is more efficient, sustainable, and practical, and whether both treatments in combination are better than either treatment alone. If the trial is conclusive, the investigators will conduct a trial in large scale to understand more the mechanism of ASD behaviors and corresponding effective interventions.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychobiotics in mental health, neurodegenerative and neurodevelopmental disorders.
   Cheng LH, Liu YW, Wu CC, Wang S, et al · · 2019 · cited 157× · PMID 31324280 · DOI 10.1016/j.jfda.2019.01.002
2. Probiotic and Oxytocin Combination Therapy in Patients with Autism Spectrum Disorder: A Randomized, Double-Blinded, Placebo-Controlled Pilot Trial.
   Kong XJ, Liu J, Liu K, Koh M, et al · · 2021 · cited 83× · PMID 34062986 · DOI 10.3390/nu13051552
3. Probiotics and oxytocin nasal spray as neuro-social-behavioral interventions for patients with autism spectrum disorders: a pilot randomized controlled trial protocol.
   Kong XJ, Liu J, Li J, Kwong K, et al · · 2020 · cited 24× · PMID 32082606 · DOI 10.1186/s40814-020-0557-8
4. Does the Gut Microbial Metabolome Really Matter? The Connection between GUT Metabolome and Neurological Disorders.
   Marć MA, Jastrząb R, Mytych J. · · 2022 · cited 18× · PMID 36235622 · DOI 10.3390/nu14193967
5. Genomic and proteomic biomarker landscape in clinical trials.
   Piñero J, Rodriguez Fraga PS, Valls-Margarit J, Ronzano F, et al · · 2023 · cited 15× · PMID 36968019 · DOI 10.1016/j.csbj.2023.03.014
6. Carbon monoxide (CO) correlates with symptom severity, autoimmunity, and responses to probiotics treatment in a cohort of children with autism spectrum disorder (ASD): a post-hoc analysis of a randomized controlled trial.
   Sherman HT, Liu K, Kwong K, Chan ST, et al · · 2022 · cited 11× · PMID 35941573 · DOI 10.1186/s12888-022-04151-3
7. Analysis of research on the effectiveness of using probiotics for children with autism spectrum disorders, in order to reduce the core and accompanying autism symptoms. Review of randomized clinical trials.
   Brzóska-Konkol E, Remberk B, Papasz-Siemienuk A. · · 2022 · cited 6× · PMID 37082415 · DOI 10.5114/ppn.2022.115244
8. Carbon Monoxide (CO) Correlates with Symptom Severity, Autoimmunity, and Responses to Probiotics Treatment in a Cohort of Children with Autism Spectrum Disorder (ASD): a Post-hoc Analysis of Randomized Controlled Trial
   Sherman HT, Liu K, Kwong K, Chan S, et al · · 2022 · DOI 10.21203/rs.3.rs-1169797/v1