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NCT01506349 · ClinicalTrials.gov registry record · NA

Assessing Neurocognitive Effects of Gluten Exposure

A NA study, sponsored by Beth Israel Deaconess Medical Center.

Terminated
Registry status
NA
Development phase
2
Enrollment target

NCT01506349: Clinical Trial NA study, sponsored by Beth Israel Deaconess Medical Center.

NCT01506349 is a NA study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01506349, a NA study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.

TERMINATED
Registry status
NA
Development phase
2 participants
Enrollment target

Study 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. 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.

Primary Outcome

Neurocognitive measurements will be made using the CogState Research computerized tests

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT gluten

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2015-06
Est. Completion 2018-03
Phase NA

Why NCT01506349 stopped before completion

NCT01506349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01506349 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01506349 about?

NCT01506349 is a clinical study titled "Assessing Neurocognitive Effects of Gluten Exposure". 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 cel...

What is the current status of trial NCT01506349?

This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2015-06. Estimated completion is 2018-03.

What interventions are being tested in trial NCT01506349?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), gluten (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01506349?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01506349's enrollment target sits among peer trials

2 1997th of 2000 the lowest 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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Source: ClinicalTrials.gov NCT01506349, the US trial registry maintained by the National Library of Medicine. NCT01506349 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.