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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK082619 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The diagnosis of celiac disease carries with it important ramifications. Celiac disease is a systemic immunologic disorder in which the sentinel lesion is an enteropathy triggered by polypeptides derived primarily from the gliadin proteins found in wheat, rye and barley. Ingestion of the offending proteins leads to inflammation and intestinal mucosal damage, which results in a spectrum of abdominal symptoms, increased intestinal permeability, malabsorption, occult gastrointestinal bleeding and diarrhea. Systemic manifestations of celiac disease include a myriad of conditions including malignancy and autoimmune disease.
The only accepted treatment for celiac disease is lifelong adherence to a gluten free diet. Adherence to this diet, simply put avoiding all foods containing even small amounts of wheat, rye and barley, has been shown to lead to improvement in the majority of related problems and normalization of all standard diagnostic tests. Because of this many individuals who present for evaluation of possible celiac disease but who are already on a gluten free diet cannot be tested accurately as there is currently no way of differentiating between healthy individuals and individuals with well treated celiac disease. The standard practice in such cases is to perform a 'Gluten Challenge' whereby the patient eats the equivalent of 2 slices of bread per day for six to eight weeks before returning for evaluation with serologic testing and endoscopy with duodenal biopsy. The use of the gluten challenge in clinical practice is limited by patient symptoms and resistance to such a long test period, after which it may take a number of weeks for the intestine to heal and the symptoms to resolve. Autoantibodies to tissue transglutaminase or antibodies to deamidated gliadin, while being excellent tools to predict celiac disease in patients who have been on a long-term gluten containing diet, display low sensitivities to detect short-term and/or recent gluten exposure. For this reason, it would be very useful if novel circulating markers could be identified that indicate the presence of celiac disease and in particular would provide an early and less invasive marker of a positive response to gluten challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low gluten group | Experimental | Subjects will eat 3g of gluten per day |
|
| High gluten group | Experimental | Subjects will eat 10g of gluten per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten | Dietary Supplement | 3g |
| |
| Gluten |
| Measure | Description | Time Frame |
|---|---|---|
| Crypt Depth to Villous Height Ratio | Histological evaluation of duodenal biopsy samples to evaluate crypt depth to villous height ratio. On the best oriented section of each biopsy fragment, villous height to crypt depth (Vh:Cd) ratio was determined by measuring the mean height /mean depth of adjacent villi/proliferative crypt zones at magnification 100x. Evaluations were considered discrepant Vh:Cd differed by more than 0.5. Overall, there was excellent concordance with the evaluations of the 165 biopsy fragments determined to be optimal for evaluation. The Vh:Cd ratios on individual biopsies from a single averaged to produce a representative Vh:Cd ratio for each endoscopy. Normal Vh:Cd ratio was regarded as 3:1 or greater. Adelman DC, Murray J, Wu TT, Mäki M, Green PH, Kelly CP. Measuring Change In Small Intestinal Histology In Patients With Celiac Disease. Am J Gastroenterol. 2018 Mar;113(3):339-347. doi: 10.1038/ajg.2017.480. Epub 2018 Feb 20. Review. PubMed PMID: 29460921. | Screening (Day -7 to -14), Day 3, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Intraepithelial Lymphocytes Per 100 Enterocytes in Duodenal Biopsy Samples | On the best oriented section of each biopsy fragment , the number of intraepithelial lymphocytes (IEL count) per 100 enterocytes was recorded at magnification 400x. IEL counts were considered discrepant if a difference of >10 IELs existed between counts. Overall, there was excellent concordance with the evaluations of the 165 biopsy fragments determined to be optimal for evaluation. The IEL counts on individual biopsies from a single endoscopy were averaged to produce a representative IEL count for each endoscopy. Adelman DC, Murray J, Wu TT, Mäki M, Green PH, Kelly CP. Measuring Change In Small Intestinal Histology In Patients With Celiac Disease. Am J Gastroenterol. 2018 Mar;113(3):339-347. doi: 10.1038/ajg.2017.480. Epub 2018 Feb 20. Review. PubMed PMID: 29460921. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ciaran P Kelly, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Daniel A Leffler, MD, MS | Beth Israel Deaconess Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3123181 | Background | Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722. | |
| 29460921 | Result | Adelman DC, Murray J, Wu TT, Maki M, Green PH, Kelly CP. Measuring Change In Small Intestinal Histology In Patients With Celiac Disease. Am J Gastroenterol. 2018 Mar;113(3):339-347. doi: 10.1038/ajg.2017.480. Epub 2018 Feb 20. |
| Label | URL |
|---|---|
| BIDMC Celiac Center Research website | View source |
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21 patients were enrolled in the study. 1 patient was found to be negative for DQ2 and DQ8, therefore did not have Celiac disease. This patient was excluded from the study. Therefore, for the study we had a total of 20 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Gluten Group | Subjects will eat 3g of gluten per day Gluten: 3g |
| FG001 | High Gluten Group | Subjects will eat 10g of gluten per day Gluten: 10g |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Gluten Challenge |
| |||||||||||||
| Completed Endoscopies |
|
Subjects with biopsy proven coelic dieasese in remission were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Gluten Group | Participants meeting inclusion criteria were randomized into the low gluten group. These participants ate two slices of wheat bread per day (3 g of gluten). Bread was procured from a standard source and gluten dose tested using the RIDASCREEN Gliadin R5 antibody ELISA. The study included a 14-day run-in period followed by a 14 day gluten challenge and a final visit 14 days post-gluten challenge. Other than the dispensed bread, subjects were instructed to remain on their gluten-free diet throughout the duration of the study. Gluten: 3g |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Crypt Depth to Villous Height Ratio | Histological evaluation of duodenal biopsy samples to evaluate crypt depth to villous height ratio. On the best oriented section of each biopsy fragment, villous height to crypt depth (Vh:Cd) ratio was determined by measuring the mean height /mean depth of adjacent villi/proliferative crypt zones at magnification 100x. Evaluations were considered discrepant Vh:Cd differed by more than 0.5. Overall, there was excellent concordance with the evaluations of the 165 biopsy fragments determined to be optimal for evaluation. The Vh:Cd ratios on individual biopsies from a single averaged to produce a representative Vh:Cd ratio for each endoscopy. Normal Vh:Cd ratio was regarded as 3:1 or greater. Adelman DC, Murray J, Wu TT, Mäki M, Green PH, Kelly CP. Measuring Change In Small Intestinal Histology In Patients With Celiac Disease. Am J Gastroenterol. 2018 Mar;113(3):339-347. doi: 10.1038/ajg.2017.480. Epub 2018 Feb 20. Review. PubMed PMID: 29460921. | Subjects with biopsy proven celiac disease in remission were enrolled. For Day 3, 17 subjects had evaluable pathology biopsies. On Day 14, 19 participants had evaluable pathology biopsies. | Posted | Mean | Standard Deviation | ratio | Screening (Day -7 to -14), Day 3, Day 14 |
4 weeks after participant received first dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Gluten Group | Subjects will eat 3g of gluten per day Gluten: 3g | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders | Other | Non-systematic Assessment | Participant developed heartburn and vomiting after drinking the lactulose/mannitol solution as part of the intestinal permeability test. Patient recovered without intervention. |
This study did have few limitations. First, the study was only moderate in size and drawn from a single center. Many subjects had significant inflammation on duodenal biopsy at baseline which may have limited the effect of gluten challenge. Finally, the high and low gluten groups were significantly different in a few factors including time since diagnosis, time on a gluten-free diet and GSRS score.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ciaran Kelly | Beth Israel Deaconess Medical Center | 617-667-1272 | ckelly2@bidmc.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005983 | Glutens |
| ID | Term |
|---|---|
| D055315 | Prolamins |
| D000078522 | Grain Proteins |
| D010940 | Plant Proteins |
| D011506 | Proteins |
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| Dietary Supplement |
10g |
|
| Screening (Day -7 to -14), Day 3, Day 14 |
| Measures of Intestinal Permeability (Urinary Lactulose to Mannitol Ratio) | LAMA evaluation has been reported to be an accurate measure of small intestinal mucosal permeability though assessment of differential absorption of lactulose and mannitol. For LAMA testing, a solution containing 7.5 g lactulose and 2 g mannitol in 100 mL of water was ingested by the participants in the evening after visit 1 and in the evening before each other study visit. The participants were asked to fast for at least 4 h and to void completely before drinking the sugar solution, then fast overnight and collect all overnight and morning urine. Urine sample analyzed for lactulose and mannitol using standardized methodology by liquid chromatography-tandem mass spectrometry. | Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28 |
| Measures of Immune Activation | IgA anti-human tissue transglutaminase assay (Inova Diagnostics, Inc., San Diego, USA): negative <20, borderline 20-30, positive >30. IgA/IgG anti- DGP assay : NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30 METHOD IS INOVA ANTI-DEAMIDATED GLIADIN PEPTIDE IGA/IGG. | Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28 |
| Assessment of Protein Expression in Intestinal Biopsies | Proportion of participants responding to a gluten challenge. Tissue transglutaminase (tTG) scoring: NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30. Deamidated gliadin peptide (DGP) scoring: NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30 METHOD IS INOVA ANTI-DEAMIDATED GLIADIN PEPTIDE IGA/IGG. | Screening (Day -7 to -14), Day 3, Day 14 |
| Symptomatic Response to Gluten Exposure Determined by Celiac Symptom Index Questionnaire | CSI (Celiac Symptom Index) scores range from 7-80. Higher scores indicate greater degree of symptoms CSI: Leffler DA, Dennis M, Edwards George J, Jamma S, Cook EF, Schuppan D, Kelly CP. A validated disease-specific symptom index for adults with celiac disease. Clin Gastroenterol Hepatol. 2009;7:1328-34. PubMed PMID: 19665584. | Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28 |
| Assessment of Protein Expression in Intestinal Biopsies Using Marsh Scores | Proportion of participants responding to a gluten challenge. Tissue transglutaminase (tTG) scoring: NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30. Deamidated gliadin peptide (DGP) scoring: NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30 METHOD IS INOVA ANTI-DEAMIDATED GLIADIN PEPTIDE IGA/IGG. | Screening (Day -7 to -14), Day 3, Day 14 |
| Symptomatic Response to Gluten Exposure Determined by Gastrointestinal Symptom Rating Scale | Measure Description: GSRS (Gastrointestinal Symptom Rating Scale) scores range 15-105 with higher scores indicating greater degree of symptoms GSRS: Svedlund J, Sjödin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988;33(2):129-134. doi:10.1007/BF01535722 | Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28 |
| 19665584 | Result | Leffler DA, Dennis M, Edwards George J, Jamma S, Cook EF, Schuppan D, Kelly CP. A validated disease-specific symptom index for adults with celiac disease. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1328-34, 1334.e1-3. doi: 10.1016/j.cgh.2009.07.031. Epub 2009 Aug 7. |
| 22619366 | Derived | Leffler D, Schuppan D, Pallav K, Najarian R, Goldsmith JD, Hansen J, Kabbani T, Dennis M, Kelly CP. Kinetics of the histological, serological and symptomatic responses to gluten challenge in adults with coeliac disease. Gut. 2013 Jul;62(7):996-1004. doi: 10.1136/gutjnl-2012-302196. Epub 2012 May 22. |
| Second Endoscopy |
|
| Third Endoscopy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | High Gluten Group | Participants meeting inclusion criteria were randomized into the low gluten group. These participants ate five slices of wheat bread per day (10 g of gluten). Bread was procured from a standard source and gluten dose tested using the RIDASCREEN Gliadin R5 antibody ELISA. The study included a 14-day run-in period followed by a 14 day gluten challenge and a final visit 14 days post-gluten challenge. Other than the dispensed bread, subjects were instructed to remain on their gluten-free diet throughout the duration of the study. Gluten: 10g |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age at Celiac Diagnosis | Mean | Standard Deviation | years |
|
| Months since Celiac Disease diagnosis | Mean | Standard Deviation | months |
|
| Laboratory Characteristics | Count of Participants | Participants |
|
| Villous height to crypt depth ratio | Villous height to crypt depth (Vh: Cd) ratio was determined by measuring the mean height/mean depth of adjacent villi/proliferative crypt zones at magnification 100x Vh:Cd and IEL count Adelman DC, Murray J, Wu TT, Mäki M, Green PH, Kelly CP. Measuring Change In Small Intestinal Histology In Patients With Celiac Disease. Am J Gastroenterol. 2018 Mar;113(3):339-347. doi: 10.1038/ajg.2017.480. Epub 2018 Feb 20. Review. PubMed PMID: 29460921. | Mean | Standard Deviation | unitless |
|
| Mean number of Intraepithelial lymphocytes | Villous lymphocyte infiltration was recorded at magnification 300 x as number of intraepithelial lymphocytes (IEL count) per 100 enterocytes Vh:Cd and IEL count Adelman DC, Murray J, Wu TT, Mäki M, Green PH, Kelly CP. Measuring Change In Small Intestinal Histology In Patients With Celiac Disease. Am J Gastroenterol. 2018 Mar;113(3):339-347. doi: 10.1038/ajg.2017.480. Epub 2018 Feb 20. Review. PubMed PMID: 29460921. | Mean | Standard Deviation | unitless |
|
| Baseline tissue transglutaminase (tTG) | NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30 | Mean | Standard Deviation | units |
|
| Baseline Deamidated gliadin peptide (DGP) | NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30 METHOD IS INOVA ANTI-DEAMIDATED GLIADIN PEPTIDE IGA/IGG. | Mean | Standard Deviation | units |
|
| Baseline Celiac Dietary Adherence test (CDAT) | CDAT scores range from 7-35 for scores. Lower scores indicate better dietary adherence | Mean | Standard Deviation | scores on a scale |
|
| Baseline Celiac Symptom Index (CSI) | CSI (Celiac Symptom Index) scores range from 7-80. Higher scores indicate greater degree of symptoms CSI: Leffler DA, Dennis M, Edwards George J, Jamma S, Cook EF, Schuppan D, Kelly CP. A validated disease-specific symptom index for adults with celiac disease. Clin Gastroenterol Hepatol. 2009;7:1328-34. PubMed PMID: 19665584. | Mean | Standard Deviation | scores on a scale |
|
| Baseline Gastrointestinal Symptom Rating Scale (GSRS) | GSRS (Gastrointestinal Symptom Rating Scale) scores range 15-105 with higher scores indicating greater degree of symptoms GSRS: Svedlund J, Sjödin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988;33(2):129-134. doi:10.1007/BF01535722 | Mean | Standard Deviation | scores on a scale |
|
| Baseline Quality of Life Visual Analog Scale (VAS) | VAS (Quality of Life Visual Analog Scale) scores range from 0-100 with higher scores indicating better health related quality of life | Mean | Standard Deviation | scores on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Baseline (Day -14) Low Gluten Group | Villous height to crypt depth ratio in low gluten group In the low gluten group, subjects consumed 3 grams of gluten per day |
| OG001 | Baseline (Day -14) High Gluten Group | Villous height to crypt depth ratio in high gluten group In the high gluten group, subjects consumed 10 grams of gluten per day. |
| OG002 | Day 3 Low Gluten Group | Villous height to crypt depth ratio in low gluten group In the low gluten group, subjects consumed 3 grams of gluten per day. |
| OG003 | Day 3 High Gluten Group | Villous height to crypt depth ratio in high gluten group In the high gluten group, subjects consumed 10 grams of gluten per day. |
| OG004 | Day 14 Low Gluten Group | Villous height to crypt depth ratio in low gluten group In the low gluten group, subjects consumed 3 grams of gluten per day |
| OG005 | Day 14 High Gluten Group | Villous height to crypt depth ratio in high gluten group. In the high gluten group subjects consume 10 grams of gluten per day. |
|
|
|
| Secondary | Count of Intraepithelial Lymphocytes Per 100 Enterocytes in Duodenal Biopsy Samples | On the best oriented section of each biopsy fragment , the number of intraepithelial lymphocytes (IEL count) per 100 enterocytes was recorded at magnification 400x. IEL counts were considered discrepant if a difference of >10 IELs existed between counts. Overall, there was excellent concordance with the evaluations of the 165 biopsy fragments determined to be optimal for evaluation. The IEL counts on individual biopsies from a single endoscopy were averaged to produce a representative IEL count for each endoscopy. Adelman DC, Murray J, Wu TT, Mäki M, Green PH, Kelly CP. Measuring Change In Small Intestinal Histology In Patients With Celiac Disease. Am J Gastroenterol. 2018 Mar;113(3):339-347. doi: 10.1038/ajg.2017.480. Epub 2018 Feb 20. Review. PubMed PMID: 29460921. | Subjects with biopsy proven celiac disease in remission were enrolled. For Day 3, 17 subjects had evaluable pathology biopsies. On Day 14, 19 participants had evaluable pathology biopsies. | Posted | Mean | Standard Deviation | Count of Lymphocytes Per 100 Enterocytes | Screening (Day -7 to -14), Day 3, Day 14 |
|
|
|
|
| Secondary | Measures of Intestinal Permeability (Urinary Lactulose to Mannitol Ratio) | LAMA evaluation has been reported to be an accurate measure of small intestinal mucosal permeability though assessment of differential absorption of lactulose and mannitol. For LAMA testing, a solution containing 7.5 g lactulose and 2 g mannitol in 100 mL of water was ingested by the participants in the evening after visit 1 and in the evening before each other study visit. The participants were asked to fast for at least 4 h and to void completely before drinking the sugar solution, then fast overnight and collect all overnight and morning urine. Urine sample analyzed for lactulose and mannitol using standardized methodology by liquid chromatography-tandem mass spectrometry. | Subjects with biopsy proven celiac disease in remission were enrolled. Measures of intestinal permeability (urinary lactulose to mannitol ratio) (LAMA) . Four participants were unable to tolerate LAMA testing due to gastrointestinal symptoms. | Posted | Mean | Standard Deviation | ratio | Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28 |
|
|
|
|
| Secondary | Measures of Immune Activation | IgA anti-human tissue transglutaminase assay (Inova Diagnostics, Inc., San Diego, USA): negative <20, borderline 20-30, positive >30. IgA/IgG anti- DGP assay : NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30 METHOD IS INOVA ANTI-DEAMIDATED GLIADIN PEPTIDE IGA/IGG. | Subjects with biopsy proven celiac disease in remission were enrolled. | Posted | Mean | Standard Deviation | units on a scale | Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28 |
|
|
|
|
| Secondary | Assessment of Protein Expression in Intestinal Biopsies | Proportion of participants responding to a gluten challenge. Tissue transglutaminase (tTG) scoring: NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30. Deamidated gliadin peptide (DGP) scoring: NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30 METHOD IS INOVA ANTI-DEAMIDATED GLIADIN PEPTIDE IGA/IGG. | All 20 subjects were included for the tTG and DGP analysis. For Day 28 High Gluten Challenge Dose Group, 1 participant had both a tTG and DGP >20 which is why the count is greater than the number analyzed. | Posted | Count of Participants | Participants | Screening (Day -7 to -14), Day 3, Day 14 |
|
|
|
| Secondary | Symptomatic Response to Gluten Exposure Determined by Celiac Symptom Index Questionnaire | CSI (Celiac Symptom Index) scores range from 7-80. Higher scores indicate greater degree of symptoms CSI: Leffler DA, Dennis M, Edwards George J, Jamma S, Cook EF, Schuppan D, Kelly CP. A validated disease-specific symptom index for adults with celiac disease. Clin Gastroenterol Hepatol. 2009;7:1328-34. PubMed PMID: 19665584. | Subjects with biopsy proven celiac disease in remission were enrolled. On Day -14, one subject in the high gluten dose group missed the CSI. On Day 7 one subject in the high gluten dose group missed the CSI. On Day 14 one subject in the high gluten dose group missed the CSI. On Day 28, one subject in the high gluten dose group and one subject in the low gluten dose missed the CSI. | Posted | Mean | Standard Deviation | score on a scale | Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28 |
|
|
|
|
| Secondary | Assessment of Protein Expression in Intestinal Biopsies Using Marsh Scores | Proportion of participants responding to a gluten challenge. Tissue transglutaminase (tTG) scoring: NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30. Deamidated gliadin peptide (DGP) scoring: NEGATIVE <20, BORDERLINE 20-30, POSITIVE >30 METHOD IS INOVA ANTI-DEAMIDATED GLIADIN PEPTIDE IGA/IGG. | Only 19 subjects were evaluated for Marsh scores because one patient had a single endoscopy which did not produce evaluable samples. | Posted | Count of Participants | Participants | Screening (Day -7 to -14), Day 3, Day 14 |
|
|
|
| Secondary | Symptomatic Response to Gluten Exposure Determined by Gastrointestinal Symptom Rating Scale | Measure Description: GSRS (Gastrointestinal Symptom Rating Scale) scores range 15-105 with higher scores indicating greater degree of symptoms GSRS: Svedlund J, Sjödin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988;33(2):129-134. doi:10.1007/BF01535722 | Subjects with biopsy proven celiac disease in remission were enrolled. On Day -14, one subject in the high gluten group missed completing the GSRS. On Day 0, two subjects (one in the low gluten group and one subject in the high gluten group) missed completing the GSRS. On Day 7, one subject in the high gluten group missed completing the GSRS. On Day 14, one subject in the high gluten group missed completing the GSRS. On Day 28, one subject in the high gluten group missed completing the GSRS. | Posted | Mean | Standard Deviation | score on a scale | Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28 |
|
|
|
|
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | High Gluten Group | Subjects will eat 10g of gluten per day Gluten: 10g | 0 | 10 | 0 | 10 | 0 | 10 |
|
Not provided
Not provided
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D055314 | Seed Storage Proteins |
| Other |
| IgA/IgG anti- DGP |
|
| 0.036 |
| Superiority |
| P Value for IgA anti-tTG | ANOVA | 0.013 | Superiority |
| P Value for IgA/IgG anti-DGP | ANOVA | 0.006 | Superiority |
| DGP > 20 |
|
| tTG > 20 or DGP > 20 |
|
| t-test, 2 sided |
| 0.020 |
| Other |
| P Value for Celiac Symptom Index (CSI)score between high gluten group and low gluten group across study | ANOVA | 0.060 | Superiority |
| Marsh III or tTG >20 |
|
| Marsh III or DGP > 20 |
|
| Marsh III or DGP > 20 or tTG > 20 |
|
| t-test, 2 sided |
| 0.012 |
| Other |
| P Value for Gastrointestinal Symptom Rating Scale (GSRS) between high gluten group and low gluten group across study | ANOVA | 0.090 | Superiority |