AutismGFCFNCT01116388
A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
A study testing GFCF product with GFCF diet and product containing gluten and casein (milk protein) with GFCF diet in people with Autism and Gastrointestinal Symptoms, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Autism, Gastrointestinal Symptoms
- What is being tested?
- GFCF product with GFCF diet and product containing gluten and casein (milk protein) with GFCF diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, 77054
About this study
Official title: A Study to Assess the Role of a Gluten Free-Casein Free Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
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).
Read more
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.
- Conditions
- Autism, Gastrointestinal Symptoms
- Being tested
- GFCF product with GFCF diet, product containing gluten and casein (milk protein) with GFCF diet
- Keywords
- Autism, Gastrointestinal Disorders, Food Allergy, Gluten free, casein free diet, Diarrhea, Constipation, Reflux, Abdominal pain, Pain after eating, Self injurious behavior
- Medical subject headings
- Autistic Disorder, Gastrointestinal Diseases, Food Hypersensitivity, Diarrhea, Constipation, Gastroesophageal Reflux, Abdominal Pain, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFCF product with GFCF dietOther
Also called test product, GFCF, gluten free- casein free diet
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.
product containing gluten and casein (milk protein) with GFCF dietOther
Also called control product, product containing gluten and casein, GFCF diet
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
| Study group | Role | What they receive |
|---|---|---|
| test product | Other | product free of gluten and casein Receives: Other: GFCF product with GFCF diet |
| control product | Other | product containing gluten and milk protein Receives: Other: product containing gluten and casein (milk protein) with GFCF diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia North America
- Responsible party
- Principal investigator, Harland S. Winter, MD, Massachusetts General Hospital
- Investigators
- Harland S Winter, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116388
- Sponsor's protocol ID
- 2008-P-002385
- Acronym
- GFCF
- Status last verified
- Apr 2015
- First submitted
- 3 May 2010
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Role of a Gluten Free-Casein Free Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT01116388
- Acronym / sponsor ID
- GFCF / 2008-P-002385
- Conditions
- Autism, Gastrointestinal Symptoms
- Keywords
- Autism, Gastrointestinal Disorders, Food Allergy, Gluten free, casein free diet, Diarrhea, Constipation, Reflux, Abdominal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Nutricia North America
- Study start
- Apr 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test product | Other | Other: GFCF product with GFCF dietproduct free of gluten and casein |
| control product | Other | Other: product containing gluten and casein (milk protein) with GFCF dietproduct containing gluten and milk protein |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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:
- Subjects must present with a current history of at least two of the following persistent GI symptoms as confirmed by the study physician:
- Subject able to consume 3 tablespoons of study powder mixed in food daily for 12 weeks
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFCF product with GFCF dietAlso: test product, GFCF, gluten free- casein free dietGroup 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. | Other | test product |
| product containing gluten and casein (milk protein) with GFCF dietAlso: control product, product containing gluten and casein, GFCF dietGroup 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 | Other | control product |
Primary outcome
A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harland S Winter, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GFCF product with GFCF diet and product containing gluten and casein (milk protein) with GFCF diet in people with Autism and Gastrointestinal Symptoms, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.