A Study to Assess the Role of a Gluten Free-Casein Free Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders
研究概览
简要总结
Doctors at MassGeneral Hospital for Children (MGHfC) are doing a research study to learn if a gluten free-dairy free (GFCF) diet is helpful in improving gastrointestinal symptoms associated with autism.
Hypothesis: The gluten free/casein free diet (GFCF) will result in a higher proportion of subjects having reduction in gastrointestinal (GI) symptoms associated with autism spectrum disorders (ASD).
Primary Study Objective:
- To assess the effect of a GFCF diet on GI symptoms associated with ASD.
Secondary Objectives:
- To assess if improvements in GI symptoms result in improvements in autistic behavior when using a GFCF diet in the dietary management of GI symptoms associated with ASD
- To determine the nutritional impact of a GFCF restrictive diet
- To assess the role of food allergies in the manifestation of GI symptoms
This is a 14-week study that requires between 5 & 9 office visits. All study related activities -including physical exams, blood samples and allergy testing - and an amino acid based supplement drink, are at no cost. Research study visits will take place at MGHfC in Boston, or at Newton Wellesley Hospital in Newton, or at Lurie Center/LADDERS in Lexington.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent / Assent, as applicable must be signed prior to executing any study related procedure
- •Children, male or female, 2 to 17 years old (inclusive)
- •Confirmed diagnosis of ASD according to the diagnostic measures:
- •DSM-IV Symptom Checklist
- •Autism Diagnostic Observation Schedule(ADOS)&/or Autism Diagnostic Interview Revised(ADI-R)within 18 months prior to entry into the study
- •Subjects must present with a current history of at least two of the following persistent GI symptoms as confirmed by the study physician:
- •Diarrhea, as characterised by three or more loose stools a day for at least 8 out of 14 days
- •Constipation as characterised by less than 3 bowel movements per week, for at least a 2-week period
- •Esophageal reflux, as characterised by 3 or more episodes of regurgitation per day on 10 out of 14 days
- •Abdominal pain manifested as pain after eating or self injurious behavior on at least 8 out of 14 days
- •Suspected food allergy which is confirmed by a physician, as characterized as a recurrent reaction or association with specific foods
- •Subject able to consume 3 tablespoons of study powder mixed in food daily for 12 weeks
排除标准
- •Children with a history of anaphylaxis to dietary milk and wheat proteins
- •Children with severe concurrent illness
- •Children who are prescribed systemic steroids
- •Children currently receiving chelation therapy, hyperbaric or antifungal treatment within 1 month of entry into the study and during the study period.
- •Children with a confirmed diagnosis of celiac disease
- •Subjects who have previously tried dietary elimination of casein and gluten for at least 1 month period and failed to demonstrate a response by parent perception
- •Children who are unable to consume 3 tablespoons of study powder mixed in food daily for 12 weeks daily
结局指标
主要结局
A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders
时间窗: 12 weeks
The effect of a GFCF diet on the dietary management of GI symptoms associated with autism is the primary outcome measure in the study.
次要结局
未报告次要终点
研究者
Harland S. Winter, MD
Director, Pediatric Inflammatory Bowel Disease Center
Massachusetts General Hospital