The Effects of Probiotics and Oxytocin Nasal Spray on Social Behaviors of ASD Children- A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Social Responsiveness Scale (SRS) Edition 2
研究概览
简要总结
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.
详细描述
This study description is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines that are published for the evaluation of randomized controlled trials. This clinical trial is a randomized, double-blind placebo controlled study. Subjects will be randomized to 2 groups:
Phase 1: a. oral placebo, and b. oral probiotics; Phase 2: a. intranasal Oxytocin(OXT) + oral placebo, and b. intranasal OXT + oral probiotics
The treatment will proceed for a total of 28 weeks. In the first phase (16 weeks), all the patients will be randomly and proportionally divided into two groups: Group A (30 subjects) receives oral probiotics while Group B (30 subjects) receives an oral placebo. In the second phase, subjects in Group A and Group B will continue their respective oral probiotics or placebo administration as in Phase 1. In addition, both groups will be simultaneously administered with intranasal OXT spray.
Testing will be performed 3 times total (before, during, and after treatment). The tests include behavioral surveys, cognitive tests, clinical autonomic tests, and blood tests for oxytocin levels. Investigators plan to select up to 10 subjects from each group to conduct a series of MRI studies at week 0, week 16 and week 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
this study will be double blinded for both participants/guardians and medication administrator
入排标准
- 年龄范围
- 3 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 3-25years old;
- •Pre-existing diagnosis of autism; subjects may be asked to provide documentation confirming diagnosis by DSM-V-TR criteria, ADOS, ADI-R, or other clinical forms
- •A care provider who can reliably bring the participant to study visits;
- •No planned changes in medications or psychosocial interventions during trial (stable medications within the last 2 weeks);
- •Willingness to provide blood samples
排除标准
- •Pregnant woman (before or during the study).
- •Comorbidity of other neurological and/or psychiatric disorders such as unstable seizures, schizophrenia, schizoaffective disorder, bipolar disorders or history of substance abuse.
- •Psychotropic medication use
- •Subjects with active cardiovascular disease that is not controlled by medication.
- •Oxytocin, antibiotic, or probiotic use within the last 30 days.
- •Regular nasal obstruction or nosebleeds
- •Significant hearing, vision, or motor impairments
- •Habitual consumption of large volumes of water
- •Started taking new medications within the last 2 weeks
研究组 & 干预措施
oral probiotics and oxytocin spray
Subjects will receive oral probiotics, 2 pills per day, for 28 weeks. For the last 12 weeks, subjects will also receive intranasal oxytocin spray at the following dose: 4 IU in week 1, 8 IU in week 2, 16 IU in week 3, and 24 IU in weeks 4-12.
干预措施: intranasal oxytocin (Drug)
oral probiotics and oxytocin spray
Subjects will receive oral probiotics, 2 pills per day, for 28 weeks. For the last 12 weeks, subjects will also receive intranasal oxytocin spray at the following dose: 4 IU in week 1, 8 IU in week 2, 16 IU in week 3, and 24 IU in weeks 4-12.
干预措施: oral probiotics (Dietary Supplement)
oral placebo and oxytocin spray
Subjects will receive oral placebo, 2 pills per day, for 28 weeks. For the last 12 weeks, subjects will also receive intranasal oxytocin spray at the following dose: 4 IU in week 1, 8 IU in week 2, 16 IU in week 3, and 24 IU in weeks 4-12.
干预措施: intranasal oxytocin (Drug)
oral placebo and oxytocin spray
Subjects will receive oral placebo, 2 pills per day, for 28 weeks. For the last 12 weeks, subjects will also receive intranasal oxytocin spray at the following dose: 4 IU in week 1, 8 IU in week 2, 16 IU in week 3, and 24 IU in weeks 4-12.
干预措施: oral placebo (Dietary Supplement)
结局指标
主要结局
Social Responsiveness Scale (SRS) Edition 2
时间窗: change from baseline at 0, 16, and 28 weeks
social communication and behavior - The scoring is based on T-score which is based on the sum of responses as follows (76 to higher - severe, 66 to 75- moderate deficiencies, 60 to 65 - mild deficiencies, 59 and below is not clinically significant for ASD).
Aberrant Behavior Checklist (ABC) Edition 2
时间窗: change from baseline at 0, 16, and 28 weeks
social behavior test - The total score is calculated based on 5 sub-scales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactive/Noncompliance, and Inappropriate Speech). There are 58 questions that are scored on a 0-3 scale 0 -"not at all a problem", 1- "the behavior is a problem but slight in degree", 2- "the problem is moderately serious" and 3- "the problem is severe in degree". Based on this sub-scores are calculated and added to get the total score.
次要结局
- Autonomic indices 4(change from baseline at 0, 16, and 28 weeks)
- structural MRI(change from baseline at 0, 16, and 28 weeks)
- Functional MRI (resting state)(change from baseline at 0, 16, and 28 weeks)
- Functional MRI (task based)(change from baseline at 0, 16, and 28 weeks)
- Autonomic indices 1(change from baseline at 0, 16, and 28 weeks)
- Autonomic indices 5(change from baseline at 0, 16, and 28 weeks)
- Microbiome(change from baseline at 0, 16, and 28 weeks)
- Neuroinflammation and Oxytocin levels(change from baseline at 0, 16, and 28 weeks)
- Autonomic indices 2(change from baseline at 0, 16, and 28 weeks)
- Autonomic indices 3(change from baseline at 0, 16, and 28 weeks)
- Eye tracking and behavioral task (emotion response)(change from baseline at 0, 16, and 28 weeks)
- Eye tracking and behavioral task (eye behavior)(change from baseline at 0, 16, and 28 weeks)
- Eye tracking and Behavioral task (joint attention)(change from baseline at 0, 16, and 28 weeks)
研究者
Xuejun Kong,MD
Research Investigator
Massachusetts General Hospital