Effect of Limosilactobacillus Reuteri on Social Deficits in Children With Autistic Spectrum Disorder
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sanna H Nystrom, PhD
- 전화번호: +46761483866
- 이메일: sny@biogaia.se
연구 연락처 백업
- 이름: Anna Pauter, PhD
- 전화번호: +46 76 328 04 77
- 이메일: anp@biogaia.se
연구 장소
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Maipú
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Mendoza, Maipú, 아르헨티나, M5515DUF
- Sanatorio Maipú
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연락하다:
- Romina L Squartini, MD
- 전화번호: +54 261 7539084
- 이메일: lrsquartini@gmail.com
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연락하다:
- Eugenia Yañez
- 전화번호: +54 261 6594152
- 이메일: eyanezic@gmail.com
-
수석 연구원:
- Romina L Squartini, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Probiotics
Probiotic oil drops formulation. Administered once daily. |
Combination of L. reuteri strains. |
|
위약 비교기: Placebo
Placebo oil drops formulation. Administered once daily. |
Placebo identical to the active product, except the addition of probiotics. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Social Responsiveness Scale-2 (SRS-2) score
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) Calibrated Severity Score (CSS) for Social Affect
기간: 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
기간: 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)
|
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Change in GI symptoms
기간: 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
기간: 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)
|
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Proportion of responders
기간: At 6 months
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Proportion of responders at 6 months, evaluating all assessments and questionnaires, in the L. reuteri group compared to the placebo group. |
At 6 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Family Quality of Life
기간: 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
기간: 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)
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Impact of dietary habits
기간: At baseline and end of study (6 months)
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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)
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Changes in gut microbiota structure and composition
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Romina L Squartini, MD, Sanatorio Maipú
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CSUB0223
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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