NCT01116388

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

5 years

First QC Date

May 3, 2010

Last Update Submit

April 7, 2015

Conditions

AutismGastrointestinal Symptoms

Keywords

AutismGastrointestinal DisordersFood AllergyGluten free, casein free dietDiarrheaConstipationRefluxAbdominal painPain after eatingSelf injurious behavior

Outcome Measures

Primary Outcomes (1)

  • A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders

    The effect of a GFCF diet on the dietary management of GI symptoms associated with autism is the primary outcome measure in the study.

    12 weeks

Study Arms (2)

test product

OTHER

product free of gluten and casein

Other: GFCF product with GFCF diet

control product

OTHER

product containing gluten and milk protein

Other: product containing gluten and casein (milk protein) with GFCF diet

Interventions

GFCF product with GFCF dietOTHER

Group I: will receive the test product (product free of gluten and casein) with GFCF Diet for the 1st 6-weeks. Group II: will receive the test product (product free of gluten and casein) with GFCF diet for the 2nd 6-weeks.

Also known as: test product, GFCF, gluten free- casein free diet
test product
product containing gluten and casein (milk protein) with GFCF dietOTHER

Group I: will receive the control product (product containing gluten and casein) with the GFCF diet for the 2nd 6-weeks. Group II: will receive the control product (product containing gluten and casein) with the GFCF diet for the 1st 6-weeks

Also known as: control product, product containing gluten and casein, GFCF diet
control product

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Autistic DisorderGastrointestinal DiseasesFood HypersensitivityDiarrheaConstipationGastroesophageal RefluxAbdominal PainSelf-Injurious Behavior

Interventions

CaseinsMilk ProteinsControl Groups

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersDigestive System DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesPainNeurologic ManifestationsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Animal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPhosphoproteinsFoodDiet, Food, and NutritionPhysiological PhenomenaMilkDairy ProductsFood and BeveragesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Harland S Winter, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pediatric Inflammatory Bowel Disease Center

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 5, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

US(2)