AutismNCT01625299
Pilot Study of Diet and Behavior in Children With Autism
A study testing Gluten and dry milk in people with Autism, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
We hypothesize that in children with autism dietary antigens can change the intestine, making it "leaky" and then affecting the brain changing their behavior. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- Gluten and dry milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Mar 2011
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 3 and 12 years,
- DSM-IV (APA, 2000) diagnosis of Autistic Disorder (DSM-IV 299.90),
- willingness to follow and maintain a gluten-free-dairy-free-diet for 4 weeks.
Who cannot join
- food allergies,
- celiac disease,
- inflammatory bowel disease,
- infectious gastrointestinal,
- seizure disorder,
- neurological problems with behavioral changes,
- unwillingness to undertake the dietary challenge with milk and gluten or to maintain a gluten-free-dairy-free-diet during the study were excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center At Houston
Houston, Texas, 77030
About this study
Official title: PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism
We hypothesize that in children with autism dietary antigens can change the intestine, making it "leaky" and then affecting the brain changing their behavior.
Read the detailed description
Subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).
- Conditions
- Autism
- Being tested
- Gluten and dry milk, Placebo
- Keywords
- intestinal permeability, diet, gluten, dairy
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten and dry milkDietary supplement
Also called Gluten and dairy group
0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
PlaceboDietary supplement
Also called Control group
Rice flour 1.0 g/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Gluten and Milk group | Experimental | Subject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily Receives: Dietary Supplement: Gluten and dry milk |
| Rice flour | Placebo comparator | Subjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Permeability
Changes in intestinal permeability and behavior with changes in diet
Measured: baseline, 2 weeks and 4 weeks
Secondary outcomes (2)
Psychometric testing
Behavioral variables: hyperactivity, innatention, irritability
Measured: baseline, 2 weeks and 4 weeks
Gastrointestinal symptoms
Changes in gastrointestinal symptoms with different diets
Measured: baseline, week 2, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionMar 2011
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 The University of Texas Health Science Center, HoustonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Navarro, The University of Texas Health Science Center, Houston
- Investigators
- Fernando Navarro, M.D>, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625299
- Sponsor's protocol ID
- HSC-MS-07-0223
- Status last verified
- Jun 2012
- First submitted
- 19 Jun 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism
- ClinicalTrials.gov ID
- NCT01625299
- Acronym / sponsor ID
- HSC-MS-07-0223
- Conditions
- Autism
- Keywords
- intestinal permeability, diet, gluten, dairy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Jun 2012 (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.
We hypothesize that in children with autism dietary antigens can change the intestine, making it "leaky" and then affecting the brain changing their behavior.
Detailed description
Subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gluten and Milk group | Experimental | Dietary Supplement: Gluten and dry milkSubject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily |
| Rice flour | Placebo comparator | Dietary Supplement: PlaceboSubjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo) |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between the ages of 3 and 12 years,
- DSM-IV (APA, 2000) diagnosis of Autistic Disorder (DSM-IV 299.90),
- willingness to follow and maintain a gluten-free-dairy-free-diet for 4 weeks.
Key exclusion criteria (7 listed)
- food allergies,
- celiac disease,
- inflammatory bowel disease,
- infectious gastrointestinal,
- seizure disorder,
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 |
|---|---|---|
| Gluten and dry milkAlso: Gluten and dairy group0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk | Dietary supplement | Gluten and Milk group |
| PlaceboAlso: Control groupRice flour 1.0 g/kg/day | Dietary supplement | Rice flour |
Primary outcome
Intestinal Permeability
Time frame: baseline, 2 weeks and 4 weeks
Changes in intestinal permeability and behavior with changes in diet
2 secondary outcomes
Psychometric testing
Time frame: baseline, 2 weeks and 4 weeks
Gastrointestinal symptoms
Time frame: baseline, week 2, week 4
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 21 Jun 2012.
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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.
Fernando Navarro, M.D> principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten and dry milk in people with Autism, run by The University of Texas Health Science Center, Houston at 1 site 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 3 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 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Intestinal Permeability (time frame: baseline, 2 weeks and 4 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 21 Jun 2012.