Celiac DiseaseNCT01506349
Assessing Neurocognitive Effects of Gluten Exposure
A study testing gluten in people with Celiac Disease and Neurobehavioral Manifestations, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Many patients with celiac disease complain of neurocognitive symptoms such as mental confusion, grogginess, difficulty with concentration and forgetfulness after exposure to gluten. However, there is little data on any possible association between impaired cognitive function and gluten intake in celiac disease. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Celiac Disease, Neurobehavioral Manifestations
- What is being tested?
- gluten
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Mar 2018
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female
- 18-50 years of age
- Celiac Disease Group: Positive small intestinal biopsies meeting Marsh II or III histologic criteria for celiac disease at least six months since the time of study entrance as well as positive IgA anti-tissue transglutaminase antibody or positive IgA/IgG anti-Deamidated Gliadin Peptide (DGP) with normal serum IgA
- Non-Celiac Gluten Sensitive Group: Negative small intestinal biopsies and negative IgA anti-tissue transglutaminase (tTG) or negative IgA/IgG anti-Deamidated Gliadin Peptide (DGP) with normal serum IgA, but with symptomatic response to gluten withdrawal
- Subject should have well controlled celiac disease and have been on a gluten-free diet for at least six months prior to study enrollment
- Subject must provide informed consent, as approved by the Institutional Review Board, and agree to complete required study visits, blood work neuropsychological testing and a urine pregnancy test (if applicable).
- Subject agrees to use appropriate birth control for the duration of the study.
Who cannot join
- Subject has other food intolerances or food allergies (other than gluten) that would interfere with the conduct of the study (e.g. corn starch, soy).
- Subject has a history of severe, acute symptomatic reactions to sporadic gluten ingestion
- Subject has any chronic active gastrointestinal disease other than celiac disease (e.g. Crohn's disease, irritable bowel syndrome, autoimmune enteropathy, eosinophilic enteritis).
- Subject should not have daily symptoms concerning for brain fog such as mental confusion or difficulty concentrating, at baseline.
- Subject has symptomatic neurological or psychiatric disease(s) that would interfere with the conduct of the study.
- Subject should not have been on corticosteroids or other immunosuppressive agents in the past 3 months.
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- Significant other co-morbidity as determined by the Principal Investigator
- Subject is deemed inappropriate by the Principal Investigator.
- Subject is pregnant or breast-feeding at time of participation.
- Subject weighs less than 110 pounds.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: An Assessment of Neurocognitive Symptoms After Gluten Exposure in Adult Patients With Celiac Disease - a Pilot Study
Many patients with celiac disease complain of neurocognitive symptoms such as mental confusion, grogginess, difficulty with concentration and forgetfulness after exposure to gluten. However, there is little data on any possible association between impaired cognitive function and gluten intake in celiac disease. The investigators predict that patients with celiac disease, when exposed to gluten, will experience neurocognitive symptoms such as confusion, forgetfulness and difficulty concentrating.
The goals of this study are to determine the prevalence of neurocognitive symptoms after exposure to gluten in patients with celiac disease and to characterize the nature of these symptoms both in terms of their duration and severity.
- Conditions
- Celiac Disease, Neurobehavioral Manifestations
- Being tested
- gluten, Placebo
- Keywords
- celiac disease, gluten, fog, attention
- Medical subject headings
- Celiac Disease, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutenDietary supplement
4 grams of gluten.
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Crossover Group 1 | Experimental | Group 1 will consume 4 grams of gluten before neurocognitive testing at Visit 2.
Group 1 will consume placebo before neurocognitive testing at Visit 3. Receives: Dietary Supplement: gluten; Dietary Supplement: Placebo |
| Crossover Group 2 | Experimental | Group 2 will consume placebo before neurocognitive testing at Visit 2.
Group 2 will consume 4 grams of gluten before neurocognitive testing at Visit 3. Receives: Dietary Supplement: gluten; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in neurocognitive measurements
Neurocognitive measurements will be made using the CogState Research computerized tests
Measured: Baseline, Visit 2 (2 to 6 weeks after baseline), Visit 3 (2 to 6 weeks after Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJun 2015
- Primary completionOct 2017
- Study completionMar 2018
Why it stopped: enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Leffler, Beth Israel Deaconess Medical Center
- Investigators
- Daniel A Leffler, MD, MS, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506349
- Sponsor's protocol ID
- 2011P000354
- Status last verified
- Mar 2018
- First submitted
- 25 Oct 2011
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Neurocognitive Symptoms After Gluten Exposure in Adult Patients With Celiac Disease - a Pilot Study
- ClinicalTrials.gov ID
- NCT01506349
- Acronym / sponsor ID
- 2011P000354
- Conditions
- Celiac Disease, Neurobehavioral Manifestations
- Keywords
- celiac disease, gluten, fog, attention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Jan 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.
Many patients with celiac disease complain of neurocognitive symptoms such as mental confusion, grogginess, difficulty with concentration and forgetfulness after exposure to gluten. However, there is little data on any possible association between impaired cognitive function and gluten intake in celiac disease. The investigators predict that patients with celiac disease, when exposed to gluten, will experience neurocognitive symptoms such as confusion, forgetfulness and difficulty concentrating.
The goals of this study are to determine the prevalence of neurocognitive symptoms after exposure to gluten in patients with celiac disease and to characterize the nature of these symptoms both in terms of their duration and severity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crossover Group 1 | Experimental | Dietary Supplement: gluten, Dietary Supplement: PlaceboGroup 1 will consume 4 grams of gluten before neurocognitive testing at Visit 2. Group 1 will consume placebo before neurocognitive testing at Visit 3. |
| Crossover Group 2 | Experimental | Dietary Supplement: gluten, Dietary Supplement: PlaceboGroup 2 will consume placebo before neurocognitive testing at Visit 2. Group 2 will consume 4 grams of gluten before neurocognitive testing at Visit 3. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female
- 18-50 years of age
- Celiac Disease Group: Positive small intestinal biopsies meeting Marsh II or III histologic criteria for celiac disease at least six months since the time of study entrance as well as positive IgA anti-tissue transglutaminase antibody or positive IgA/IgG anti-Deamidated Gliadin Peptide (DGP) with normal serum IgA
- Non-Celiac Gluten Sensitive Group: Negative small intestinal biopsies and negative IgA anti-tissue transglutaminase (tTG) or negative IgA/IgG anti-Deamidated Gliadin Peptide (DGP) with normal serum IgA, but with symptomatic response to gluten withdrawal
- Subject should have well controlled celiac disease and have been on a gluten-free diet for at least six months prior to study enrollment
Key exclusion criteria (10 listed)
- Subject has other food intolerances or food allergies (other than gluten) that would interfere with the conduct of the study (e.g. corn starch, soy).
- Subject has a history of severe, acute symptomatic reactions to sporadic gluten ingestion
- Subject has any chronic active gastrointestinal disease other than celiac disease (e.g. Crohn's disease, irritable bowel syndrome, autoimmune enteropathy, eosinophilic enteritis).
- Subject should not have daily symptoms concerning for brain fog such as mental confusion or difficulty concentrating, at baseline.
- Subject has symptomatic neurological or psychiatric disease(s) that would interfere with the conduct of the study.
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 |
|---|---|---|
| gluten4 grams of gluten. | Dietary supplement | Crossover Group 1, Crossover Group 2 |
| Placebo | Dietary supplement | Crossover Group 1, Crossover Group 2 |
Primary outcome
change in neurocognitive measurements
Time frame: Baseline, Visit 2 (2 to 6 weeks after baseline), Visit 3 (2 to 6 weeks after Visit 2)
Neurocognitive measurements will be made using the CogState Research computerized tests
Results and safety
The study was stopped early (reason given: enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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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.
Daniel A Leffler, MD, MS principal investigator
Beth Israel Deaconess Medical Center
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 in people with Celiac Disease and Neurobehavioral Manifestations, run by Beth Israel Deaconess Medical Center 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 20 Mar 2018. 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. 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 was stopped early (reason given: enrollment). Results are not available in the source record.
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?
change in neurocognitive measurements (time frame: Baseline, Visit 2 (2 to 6 weeks after baseline), Visit 3 (2 to 6 weeks after Visit 2)). 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 20 Mar 2018.