N/A
N=20
Serum Markers in Gluten Challenge
Celiac Disease
Bottom Line
View on ClinicalTrials.gov: NCT00931892 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Crypt Depth to Villous Height Ratio — 2.05; 4.33; 1.19; 2.02 ratio — p=0.670
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gluten (Dietary_supplement)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crypt Depth to Villous Height Ratio |
2.05; 4.33; 1.19; 2.02; 0.98; 1.26 | 0.670 |
| SECONDARY Count of Intraepithelial Lymphocytes Per 100 Enterocytes in Duodenal Biopsy Samples |
37.08; 28.91; 44.89; 30.68; 47.95; 52.36 | 0.409 |
| SECONDARY Measures of Intestinal Permeability (Urinary Lactulose to Mannitol Ratio) |
0.23; 0.24; 0.65; 0.17; 0.25; 0.44 | 0.387 |
| SECONDARY Measures of Immune Activation |
6.70; 10.34; 13.76; 11.50; 11.84; 10.34 | 0.010 sig |
| SECONDARY Assessment of Protein Expression in Intestinal Biopsies |
3; 2; 5; 6; 8; 8 | — |
| SECONDARY Symptomatic Response to Gluten Exposure Determined by Celiac Symptom Index Questionnaire |
28.5; 22.5; 28.44; 23.00; 30.33; 27.54 | 0.05 |
| SECONDARY Assessment of Protein Expression in Intestinal Biopsies Using Marsh Scores |
5; 8; 0; 0; 5; 8 | — |
| SECONDARY Symptomatic Response to Gluten Exposure Determined by Gastrointestinal Symptom Rating Scale |
21.63; 19.20; 22.88; 18.40; 30.22; 26.45 | 0.01 sig |
Summary
1. The purpose of this research study is to evaluate non-invasive markers of celiac disease activity in subjects that are on a gluten-free diet, in remission from celiac disease who undergo gluten challenge.
2. The secondary aims of this protocol are to identify novel mediators important in the pathophysiology of celiac disease and to evaluate changes in metabolism with gluten exposure.
Eligibility Criteria
Inclusion Criteria
- Age between 17 and 72 years, inclusive.
- Subject must have been diagnosed with celiac disease by duodenal / jejunal biopsy at least 6 months prior to entrance into the study.
- Subject has Anti-Tissue Transglutaminase (anti-tTG) ≤ 20 EU as measured by serology.
- Subject must be on a gluten-free diet for at least the past 6 months.
- Female subjects should be either post-menopausal (amenorrhea for at least 24 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) with a negative urine beta human chorionic gonadotropin (HCG) pregnancy test prior to entering the study and who are using or agree to use acceptable methods of contraception. Abstinence is an acceptable means of avoiding pregnancy as long as the subject agrees to use contraception if they become sexually active. Acceptable contraceptives include intrauterine devices (IUDs), hormonal contraceptives (oral, depo, patch or injectable) in use for one month prior to screening and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits.
- BMI between 18.5 and 38, inclusive.
Exclusion Criteria
- Subject has Anti-Tissue Transglutaminase (anti-tTG) > 20 EU as measured by serology.
- Subject has other food intolerances or food allergies (other than celiac disease) that would interfere with the conduct of the study).
- Subject has a history of severe acute symptomatic reactions to sporadic gluten ingestion
- Subject has any chronic active GI disease other than celiac disease (e.g. Crohn's disease, IBS).
- Subjects with symptomatic neurological or psychiatric disease(s) that would interfere with the conduct of the study.
- Subject has clinically significant abnormal laboratory test results at the screening visit or as determined by the Principal Investigator
- Subject is pregnant or breast feeding.
- Subject (premenopausal females) is sexually active without contraception.
- Subject should not have been on steroids in the past 3 months.
- Subject is deemed inappropriate by the Principal Investigator.
Data sourced from ClinicalTrials.gov (NCT00931892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.