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NCT01116388 · ClinicalTrials.gov registry record · NA
A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT01116388: Completed NA study, sponsored by Massachusetts General Hospital.
NCT01116388 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116388, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study 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.
Primary Outcome
The effect of a GFCF diet on the dietary management of GI symptoms associated with autism is the primary outcome measure in the study.
Interventions
- OTHER GFCF product with GFCF diet
- OTHER product containing gluten and casein (milk protein) with GFCF diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2010-04 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01116388 record still lists
NCT01116388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which GFCF product with GFCF diet is the first listed.
NCT01116388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116388 about?
NCT01116388 is a clinical study titled "A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) 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 subjec...
What is the current status of trial NCT01116388?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2010-04. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01116388?
The interventions under investigation include: GFCF product with GFCF diet (OTHER), product containing gluten and casein (milk protein) with GFCF diet (OTHER).
Who is sponsoring clinical trial NCT01116388?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01116388's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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