← Back to Search

control product for Autism Spectrum Disorder (GFCF Trial)

N/A
Waitlist Available
Led By Harland S Winter, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

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.

Eligible Conditions
  • Autism Spectrum Disorder
  • Gastrointestinal Symptoms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders

Trial Design

2Treatment groups
Experimental Treatment
Group I: test productExperimental Treatment1 Intervention
product free of gluten and casein
Group II: control productExperimental Treatment1 Intervention
product containing gluten and milk protein

Find a Location

Who is running the clinical trial?

Nutricia North AmericaIndustry Sponsor
6 Previous Clinical Trials
187 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,997 Previous Clinical Trials
13,231,415 Total Patients Enrolled
43 Trials studying Autism Spectrum Disorder
3,128 Patients Enrolled for Autism Spectrum Disorder
Harland S Winter, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
231 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
131 Patients Enrolled for Autism Spectrum Disorder
~4 spots leftby Sep 2025