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Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder

2026年9月28日 更新者：BioGaia AB

Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder: a Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study

This is a double-blind, randomized, placebo-controlled, parallel-group study in children with Autism Spectrum Disorder (ASD) to evaluate the effect of a probiotic product on the ASD symptoms.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Sanna H Nystrom, PhD
  • 电话号码：+46761483866
  • 邮箱：sny@biogaia.se

研究联系人备份

  • 姓名：Anna Pauter, PhD
  • 电话号码：+46 76 328 04 77
  • 邮箱：anp@biogaia.se

学习地点

  • 阿根廷
    • Maipú
      • Mendoza、Maipú、阿根廷、M5515DUF
        • Sanatorio Maipú
        • 接触：
        • 接触：
        • 首席研究员：
          • Romina L Squartini, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

4年 至 12年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Boys or girls aged between 4 to 12 years at screening.
  • ASD diagnosis confirmed by a qualified clinician according to DMS-5 criteria, M-CHAT used as a screening tool.
  • Parents/caregivers/legal guardians are ≥18 years.
  • Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires, and report regularly during the intervention period.
  • Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
  • Parents/caregivers/legal guardians willing and able to give informed consent for their and their child's participation in the study.

Exclusion Criteria:

  • Neurological syndromes that could explain autism disorders.
  • Organic gastrointestinal disorders (e.g. IBD, peptic ulcers and cancer). Celiac disease is accepted
  • Any other severe clinically relevant disease or disorder which may affect the participation in the study, based on the investigator's judgement.
  • Allergy or intolerance to one of the excipients of the probiotic product.
  • Children with reported exposure to probiotic supplements in the 15 days prior to Screening Visit (V1).
  • Children with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1).
  • Children with reported exposure to proton pump inhibitors in the 7 days prior to Screening Visit (V1).
  • Participation in other interventional clinical study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Probiotics

Probiotic oil drops formulation. Administered once daily.
膳食补充剂：Probiotics

Combination of L. reuteri strains.
安慰剂比较：Placebo

Placebo oil drops formulation. Administered once daily.
膳食补充剂：Placebo

Placebo identical to the active product, except the addition of probiotics.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Changes in Social Responsiveness Scale-2 (SRS-2) score
大体时间：From baseline to end of study (6 months)

Changes in the SRS-2 score in the L. reuteri group compared to the placebo group. The SRS-2 is a 65-item questionnaire, with higher scores indicating greater social impairment and severity of autism-related traits.
From baseline to end of study (6 months)

次要结果测量

结果测量
措施说明
大体时间
Change in Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) Calibrated Severity Score (CSS) for Social Affect
大体时间：From baseline to end of study (6 months)

Change in ADOS-2 CSS for Social Affect in the L. reuteri group compared to the placebo group.

ADOS-2 is a semi-structured, standardized assessment that observes social interaction, communication, play, and restricted or repetitive behaviors across five modules tailored to age and language level. Higher scores indicate a higher level of autism-related behaviors.
From baseline to end of study (6 months)
Change in total Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) score
大体时间：From baseline to end of study (6 months)

Change in total ADOS-2 score in the L. reuteri group compared to the placebo group.

ADOS-2 is a semi-structured, standardized assessment that observes social interaction, communication, play, and restricted or repetitive behaviors across five modules tailored to age and language level. Higher scores indicate a higher level of autism-related behaviors.
From baseline to end of study (6 months)
Change in GI symptoms
大体时间：From baseline to end fo study (6 months)

Change in GI symptoms, assessed by the 6 item Gastrointestinal Severity Index (6-GSI) in the L. reuteri group compared to the placebo group.

6-GSI is a six item questionnaire with total score 0-12 with higher scores indicating worse outcome.
From baseline to end fo study (6 months)
Change in ABAS-2 score
大体时间：From baseline to end fo study (6 months)

Change in adaptive behaviour, assessed by the Adaptive Behavior Assessment System, Second Edition (ABAS-2) in the L. reuteri group compared to the placebo group.

ABAS-2 is a 4-point rating scale with the scoring system divided into skill area scores (range 1 to 19), domain scores (range 40 to 160) and general adaptive composite (40 to 150). A higher score indicates a better outcome.
From baseline to end fo study (6 months)
Proportion of responders
大体时间：At 6 months

Proportion of responders at 6 months, evaluating all assessments and questionnaires, in the L. reuteri group compared to the placebo group.
At 6 months

其他结果措施

结果测量
措施说明
大体时间
Change in Family Quality of Life
大体时间：From baseline to end fo study (6 months)

Change in family Quality of Life (QoL), assessed by the Pediatric Quality of Life Inventory™ Family Impact Module (PedsQL™ Family Impact Module), in the L. reuteri group compared to the placebo group.

The range of the total score is 0-100 with a higher score indicating a better outcome.
From baseline to end fo study (6 months)
Change in quality of sleep
大体时间：From baseline to end of study (6 months)

Change in sleep quality, assessed by the Children's Sleep Habits Questionnaire, in the L. reuteri group compared to placebo.

The CSHQ is scored on 33 of 52 items, using a 1-3 scale, with total score range 33-99. A higher score indicates worse outcome and the cut-off of a total score of 41 or higher indicating potential sleep problems.
From baseline to end of study (6 months)
Impact of dietary habits
大体时间：At baseline and end of study (6 months)

Impact of dietary habits, assessed by a Food Frequency Questionnaire (FFQ), on the gut microbiota profile and effect of the L. reuteri intervention.
At baseline and end of study (6 months)
Changes in gut microbiota structure and composition
大体时间：Baseline, 3 and 6 months

Changes in the gut microbiota structure and composition and the effect of the L. reuteri intervention, assessed by metagenomic analysis of fecal samples
Baseline, 3 and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

BioGaia AB

调查人员

  • 首席研究员：Romina L Squartini, MD、Sanatorio Maipú

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月15日

初级完成 (估计的)

2027年10月31日

研究完成 (估计的)

2027年10月31日

研究注册日期

首次提交

2026年9月22日

首先提交符合 QC 标准的

2026年9月22日

首次发布 (实际的)

2026年9月28日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CSUB0223

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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