Adult Form of Celiac DiseaseNCT02389062
Noninvasive Markers of Gluten Ingestion in Celiac Disease Patients
A study of Adult Form of Celiac Disease, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a clinical trial to evaluate the sensitivity of noninvasive, novel markers of gluten ingestion in celiac disease patients who are following gluten free diet for at least a period of one year. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adult Form of Celiac Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2015to 11 Feb 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study population will consist of patients with a prior diagnosis of celiac disease based on intestinal biopsy (Marsh score of 1-4) who report control of symptoms with adherence to gluten free diet(GFD) for at least one year and have a baseline IgA antibody to tissue transglutaminase(IgA-tTG) within the normal range.
Who cannot join
- Patients < 18 years of age
- Patients with refractory celiac disease (RFD), defined as persisting or recurring symptoms and mucosal villous atrophy, despite strict adherence to a gluten free diet (GFD) for >12 months and a negative IgA antibody to tissue transglutaminase (IgA-tTG)
- Patients with enteropathy-associated T-cell lymphoma
- Patients with IgA deficiency
- Patients with a diagnosis of inflammatory bowel disease, irritable bowel symptoms, or acute gastroenteritis
- Patients taking immunosuppressive medications
- Patients who are pregnant
- Patients who are breast feeding/lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Noninvasive Markers of Gluten Ingestion in Celiac Disease Patients: Prospective, Randomized,Placebo Controlled, Double Blind Clinical Trial
This is a clinical trial to evaluate the sensitivity of noninvasive, novel markers of gluten ingestion in celiac disease patients who are following gluten free diet for at least a period of one year. These noninvasive markers may be helpful to monitor the silent intestinal damage, possibly resulting from the accidental consumption of gluten due to cross contamination of gluten free diet.
Read the detailed description
The gold-standard for monitoring of dietary adherence is consultation with an expert dietitian, but this may be time-consuming for patients and local expertise may not be available. Intestinal biopsy is the only direct method to document mucosal healing and can be considered in all adults with celiac disease. Non-invasive assessment of compliance with a gluten free diet(GFD) can be achieved with monitoring of IgA antibodies to tissue transglutaminase (IgA-tTG) or deamidated gliadin peptides, as these markers improve with gluten elimination. However, intestinal mucosal damage is present in a significant number of patients who report compliance with a gluten free diet and have normalized serology, potentially due to dietary lapses or unrecognized contamination with gluten. Furthermore, serologic testing may be normal in patients with partial adherence. Patient reported surveys show promise for assessing gluten free diet adherence, but further studies are needed.
Intestinal fatty acid-binding protein (I-FABP), a small (15 kD) cytosolic protein found exclusively in the small bowel enterocytes, has been studied as a marker of intestinal epithelial damage in septic shock and mesenteric ischemia. More recently, elevated levels of intestinal fatty acid-binding protein( I-FABP) have been described as a marker of intestinal injury in both adults and children with celiac disease. Intestinal fatty acid binding protein, (I-FABP) levels have been shown to significantly correlate with the degree of villous atrophy and IgA antibody to tissue transglutaminase (IgA-tTG), as well as decrease upon treatment with a gluten free diet(GFD). Incomplete normalization of intestinal fatty acid binding protein(I-FABP) on a gluten free diet points to ongoing intestinal injury, even in the absence of circulating antibodies, thus suggesting its potential as a non-invasive marker for gluten free diet adherence and intestinal damage in celiac disease.
The measurement of gluten immunogenic peptides (GIP) in stool is a novel method to monitor gluten free diet compliance. Recently, a technique to detect gliadin 33-mer equivalent peptide epitopes (33EPs) in the stool of pediatric patients has been described. These peptides show significant resistance to digestion and were detected in healthy individuals after normal gluten-containing diet ingestion. Importantly, these peptides are not detected in patients on a gluten free diet, and there appears to be a correlation between the amount of gluten intake and the peptide levels. A similar test has been developed for gluten intestinal peptide(GIP) detection in urine, although there are currently no peer-reviewed studies examining this technique. Further research on the utility of stool and urine gluten intestinal peptide (GIP)for monitoring of gluten free diet (GFD) adherence is warranted.
Given the lack of a non-invasive and accurate measure of gluten intake in celiac disease (CD), the investigators will investigate the effect of gluten intake in celiac disease (CD) patients using a variety of markers. Patients who are symptom-free on a gluten free diet (GFD) will be exposed to various amounts of gluten. Factors that will be studied include the effect on patient estimated gluten intake, Celiac disease symptoms, IgA-tTG level,intestinal fatty acid binding protein( I-FABP) level, and both stool and urine gluten peptide levels.
- Conditions
- Adult Form of Celiac Disease
- Being tested
- Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.Other
After administering the capsules for 16 weeks during study periods, patients's blood will be tested for novel markers- Intestinal fatty acid binding protein(I-FABP), stool for gluten intestinal peptide (GIP), urine for gluten intestinal peptide(GIP), patient estimated gluten intake(PEGI), celiac severity index(CSI), Celiac dietary adherence test(CDAT) by standard questionnaire provided during the visits. These tests will be done over a period of 16 weeks and at a follow up 3 months later.
| Study group | Role | What they receive |
|---|---|---|
| Placebo controlled group | Experimental | This is a group of same number of subjects as in other arms, who will be given equivalent dose of placebo- cornstarch capsules i.e 5 capsules containing neutral substance- cornstarch(placebo) to be taken daily by mouth for a period of 12 weeks. Receives: Other: Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals. |
| High dose gluten capsules | Experimental | This group of subjects will be given high dose i.e 2.5 g of gluten containing capsules, 5 capsules to be taken daily by mouth, for a period of 12 weeks. Receives: Other: Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals. |
| Low dose gluten capsules | Experimental | This group of subjects will be given low dose i.e 0.5 g of gluten containing capsules, 5 capsules to be taken daily by mouth, for a period of 12 weeks. Receives: Other: Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Change in the patient estimated gluten intake after administration of study pills using the Celiac Dietary Adherence Test (CDAT), to be assessed at the end of follow up week 12
Measured: up to follow up week 12
Change in the Celiac disease symptoms, using the Celiac Symptom Index (CSI) after administration of study pills; to be assessed at the end of follow up week 12
questionnaire
Measured: up to follow up week 12
Change in IgA antibody to tissue transglutaminase (IgA-TTG) levels after administration of study pills, to be assessed at the end of follow up week 12.
lab
Measured: up to follow up week 12
Change in Intestinal fatty acid binding protein (I-FABP) levels after administration of study pills, to be assessed at the end of follow up week 12.
lab
Measured: up to follow up week 12
Change in stool gluten intestinal peptide (GIP) level after administration of study pills, to be assessed at the end of follow up week 12
lab
Measured: up to follow up week 12
Change in urine gluten intestinal peptide (GIP) level after administration of study pills,to be assessed at the end of follow up week 12
lab
Measured: up to follow up week 12
Change in patient estimated gluten intake(PEGI) after administration of study pills, using separate questionnaire, to be assessed at the end of follow up week 12
questionnaire
Measured: up to follow up week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start11 Feb 2015
- Primary completion11 Feb 2016
- Study completion11 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Adult Form of Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff GI, Thomas Jefferson University
- Investigators
- Anthony J. DiMarino, MD, Principal investigator, Thomas Jefferson University, Philadelphia, PA 19107
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389062
- Sponsor's protocol ID
- 14D.389
- Status last verified
- Jul 2019
- First submitted
- 12 Feb 2015
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; American College of Gastroenterology. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013 May;108(5):656-76; quiz 677. doi: 10.1038/ajg.2013.79. Epub 2013 Apr 23.
PubMed 23609613Murray JA, Watson T, Clearman B, Mitros F. Effect of a gluten-free diet on gastrointestinal symptoms in celiac disease. Am J Clin Nutr. 2004 Apr;79(4):669-73. doi: 10.1093/ajcn/79.4.669.
PubMed 15051613Lee SK, Lo W, Memeo L, Rotterdam H, Green PH. Duodenal histology in patients with celiac disease after treatment with a gluten-free diet. Gastrointest Endosc. 2003 Feb;57(2):187-91. doi: 10.1067/mge.2003.54.
PubMed 12556782Rubio-Tapia A, Rahim MW, See JA, Lahr BD, Wu TT, Murray JA. Mucosal recovery and mortality in adults with celiac disease after treatment with a gluten-free diet. Am J Gastroenterol. 2010 Jun;105(6):1412-20. doi: 10.1038/ajg.2010.10. Epub 2010 Feb 9.
PubMed 20145607Bai JC, Gonzalez D, Mautalen C, Mazure R, Pedreira S, Vazquez H, Smecuol E, Siccardi A, Cataldi M, Niveloni S, Boerr LA, Maurino E. Long-term effect of gluten restriction on bone mineral density of patients with coeliac disease. Aliment Pharmacol Ther. 1997 Feb;11(1):157-64. doi: 10.1046/j.1365-2036.1997.112283000.x.
PubMed 9042988Dickey W. Low serum vitamin B12 is common in coeliac disease and is not due to autoimmune gastritis. Eur J Gastroenterol Hepatol. 2002 Apr;14(4):425-7. doi: 10.1097/00042737-200204000-00016.
PubMed 11943958Halfdanarson TR, Kumar N, Hogan WJ, Murray JA. Copper deficiency in celiac disease. J Clin Gastroenterol. 2009 Feb;43(2):162-4. doi: 10.1097/MCG.0b013e3181354294.
PubMed 18496230Kotze LM. Gynecologic and obstetric findings related to nutritional status and adherence to a gluten-free diet in Brazilian patients with celiac disease. J Clin Gastroenterol. 2004 Aug;38(7):567-74. doi: 10.1097/01.mcg.0000131720.90598.6a.
PubMed 15232359Choi JM, Lebwohl B, Wang J, Lee SK, Murray JA, Sauer MV, Green PH. Increased prevalence of celiac disease in patients with unexplained infertility in the United States. J Reprod Med. 2011 May-Jun;56(5-6):199-203.
PubMed 21682114Khashan AS, Henriksen TB, Mortensen PB, McNamee R, McCarthy FP, Pedersen MG, Kenny LC. The impact of maternal celiac disease on birthweight and preterm birth: a Danish population-based cohort study. Hum Reprod. 2010 Feb;25(2):528-34. doi: 10.1093/humrep/dep409. Epub 2009 Nov 24.
PubMed 19939833Catassi C, Fabiani E, Iacono G, D'Agate C, Francavilla R, Biagi F, Volta U, Accomando S, Picarelli A, De Vitis I, Pianelli G, Gesuita R, Carle F, Mandolesi A, Bearzi I, Fasano A. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr. 2007 Jan;85(1):160-6. doi: 10.1093/ajcn/85.1.160.
PubMed 17209192Haines ML, Anderson RP, Gibson PR. Systematic review: The evidence base for long-term management of coeliac disease. Aliment Pharmacol Ther. 2008 Nov 1;28(9):1042-66. doi: 10.1111/j.1365-2036.2008.03820.x. Epub 2008 Jul 30.
PubMed 18671779Nachman F, Sugai E, Vazquez H, Gonzalez A, Andrenacci P, Niveloni S, Mazure R, Smecuol E, Moreno ML, Hwang HJ, Sanchez MI, Maurino E, Bai JC. Serological tests for celiac disease as indicators of long-term compliance with the gluten-free diet. Eur J Gastroenterol Hepatol. 2011 Jun;23(6):473-80. doi: 10.1097/MEG.0b013e328346e0f1.
PubMed 21537123Lanzini A, Lanzarotto F, Villanacci V, Mora A, Bertolazzi S, Turini D, Carella G, Malagoli A, Ferrante G, Cesana BM, Ricci C. Complete recovery of intestinal mucosa occurs very rarely in adult coeliac patients despite adherence to gluten-free diet. Aliment Pharmacol Ther. 2009 Jun 15;29(12):1299-308. doi: 10.1111/j.1365-2036.2009.03992.x. Epub 2009 Mar 3.
PubMed 19302264Vahedi K, Mascart F, Mary JY, Laberenne JE, Bouhnik Y, Morin MC, Ocmant A, Velly C, Colombel JF, Matuchansky C. Reliability of antitransglutaminase antibodies as predictors of gluten-free diet compliance in adult celiac disease. Am J Gastroenterol. 2003 May;98(5):1079-87. doi: 10.1111/j.1572-0241.2003.07284.x.
PubMed 12809831
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Markers of Gluten Ingestion in Celiac Disease Patients: Prospective, Randomized,Placebo Controlled, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02389062
- Acronym / sponsor ID
- 14D.389
- Conditions
- Adult Form of Celiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 11 Feb 2015 (actual)
- Primary completion
- 11 Feb 2016 (actual)
- Study completion
- 11 Feb 2017 (actual)
- First posted
- 17 Mar 2015 (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.
This is a clinical trial to evaluate the sensitivity of noninvasive, novel markers of gluten ingestion in celiac disease patients who are following gluten free diet for at least a period of one year. These noninvasive markers may be helpful to monitor the silent intestinal damage, possibly resulting from the accidental consumption of gluten due to cross contamination of gluten free diet.
Detailed description
The gold-standard for monitoring of dietary adherence is consultation with an expert dietitian, but this may be time-consuming for patients and local expertise may not be available. Intestinal biopsy is the only direct method to document mucosal healing and can be considered in all adults with celiac disease. Non-invasive assessment of compliance with a gluten free diet(GFD) can be achieved with monitoring of IgA antibodies to tissue transglutaminase (IgA-tTG) or deamidated gliadin peptides, as these markers improve with gluten elimination. However, intestinal mucosal damage is present in a significant number of patients who report compliance with a gluten free diet and have normalized serology, potentially due to dietary lapses or unrecognized contamination with gluten. Furthermore, serologic testing may be normal in patients with partial adherence. Patient reported surveys show promise for assessing gluten free diet adherence, but further studies are needed.
Intestinal fatty acid-binding protein (I-FABP), a small (15 kD) cytosolic protein found exclusively in the small bowel enterocytes, has been studied as a marker of intestinal epithelial damage in septic shock and mesenteric ischemia. More recently, elevated levels of intestinal fatty acid-binding protein( I-FABP) have been described as a marker of intestinal injury in both adults and children with celiac disease. Intestinal fatty acid binding protein, (I-FABP) levels have been shown to significantly correlate with the degree of villous atrophy and IgA antibody to tissue transglutaminase (IgA-tTG), as well as decrease upon treatment with a gluten free diet(GFD). Incomplete normalization of intestinal fatty acid binding protein(I-FABP) on a gluten free diet points to ongoing intestinal injury, even in the absence of circulating antibodies, thus suggesting its potential as a non-invasive marker for gluten free diet adherence and intestinal damage in celiac disease.
The measurement of gluten immunogenic peptides (GIP) in stool is a novel method to monitor gluten free diet compliance. Recently, a technique to detect gliadin 33-mer equivalent peptide epitopes (33EPs) in the stool of pediatric patients has been described. These peptides show significant resistance to digestion and were detected in healthy individuals after normal gluten-containing diet ingestion. Importantly, these peptides are not detected in patients on a gluten free diet, and there appears to be a correlation between the amount of gluten intake and the peptide levels. A similar test has been developed for gluten intestinal peptide(GIP) detection in urine, although there are currently no peer-reviewed studies examining this technique. Further research on the utility of stool and urine gluten intestinal peptide (GIP)for monitoring of gluten free diet (GFD) adherence is warranted.
Given the lack of a non-invasive and accurate measure of gluten intake in celiac disease (CD), the investigators will investigate the effect of gluten intake in celiac disease (CD) patients using a variety of markers. Patients who are symptom-free on a gluten free diet (GFD) will be exposed to various amounts of gluten. Factors that will be studied include the effect on patient estimated gluten intake, Celiac disease symptoms, IgA-tTG level,intestinal fatty acid binding protein( I-FABP) level, and both stool and urine gluten peptide levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo controlled group | Experimental | Other: Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.This is a group of same number of subjects as in other arms, who will be given equivalent dose of placebo- cornstarch capsules i.e 5 capsules containing neutral substance- cornstarch(placebo) to be taken daily by mouth for a period of 12 weeks. |
| High dose gluten capsules | Experimental | Other: Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.This group of subjects will be given high dose i.e 2.5 g of gluten containing capsules, 5 capsules to be taken daily by mouth, for a period of 12 weeks. |
| Low dose gluten capsules | Experimental | Other: Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.This group of subjects will be given low dose i.e 0.5 g of gluten containing capsules, 5 capsules to be taken daily by mouth, for a period of 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- This study population will consist of patients with a prior diagnosis of celiac disease based on intestinal biopsy (Marsh score of 1-4) who report control of symptoms with adherence to gluten free diet(GFD) for at least one year and have a baseline IgA antibody to tissue transglutaminase(IgA-tTG) within the normal range.
Key exclusion criteria (8 listed)
- Patients < 18 years of age
- Patients with refractory celiac disease (RFD), defined as persisting or recurring symptoms and mucosal villous atrophy, despite strict adherence to a gluten free diet (GFD) for >12 months and a negative IgA antibody to tissue transglutaminase (IgA-tTG)
- Patients with enteropathy-associated T-cell lymphoma
- Patients with IgA deficiency
- Patients with a diagnosis of inflammatory bowel disease, irritable bowel symptoms, or acute gastroenteritis
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 |
|---|---|---|
| Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.After administering the capsules for 16 weeks during study periods, patients's blood will be tested for novel markers- Intestinal fatty acid binding protein(I-FABP), stool for gluten intestinal peptide (GIP), urine for gluten intestinal peptide(GIP), patient estimated gluten intake(PEGI), celiac severity index(CSI), Celiac dietary adherence test(CDAT) by standard questionnaire provided during the visits. These tests will be done over a period of 16 weeks and at a follow up 3 months later. | Other | High dose gluten capsules, Low dose gluten capsules, Placebo controlled group |
Primary outcome
1) Change in the patient estimated gluten intake after administration of study pills using the Celiac Dietary Adherence Test (CDAT), to be assessed at the end of follow up week 12
Time frame: up to follow up week 12
Change in the Celiac disease symptoms, using the Celiac Symptom Index (CSI) after administration of study pills; to be assessed at the end of follow up week 12
Time frame: up to follow up week 12
questionnaire
Change in IgA antibody to tissue transglutaminase (IgA-TTG) levels after administration of study pills, to be assessed at the end of follow up week 12.
Time frame: up to follow up week 12
lab
Change in Intestinal fatty acid binding protein (I-FABP) levels after administration of study pills, to be assessed at the end of follow up week 12.
Time frame: up to follow up week 12
lab
Change in stool gluten intestinal peptide (GIP) level after administration of study pills, to be assessed at the end of follow up week 12
Time frame: up to follow up week 12
lab
Change in urine gluten intestinal peptide (GIP) level after administration of study pills,to be assessed at the end of follow up week 12
Time frame: up to follow up week 12
lab
Change in patient estimated gluten intake(PEGI) after administration of study pills, using separate questionnaire, to be assessed at the end of follow up week 12
Time frame: up to follow up week 12
questionnaire
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 19 Jul 2019.
- Background: PubMed 23609613Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; American College of Gastroenterology. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013 May;108(5):656-76; quiz 677. doi: 10.1038/ajg.2013.79. Epub 2013 Apr 23.
- Background: PubMed 15051613Murray JA, Watson T, Clearman B, Mitros F. Effect of a gluten-free diet on gastrointestinal symptoms in celiac disease. Am J Clin Nutr. 2004 Apr;79(4):669-73. doi: 10.1093/ajcn/79.4.669.
- Background: PubMed 12556782Lee SK, Lo W, Memeo L, Rotterdam H, Green PH. Duodenal histology in patients with celiac disease after treatment with a gluten-free diet. Gastrointest Endosc. 2003 Feb;57(2):187-91. doi: 10.1067/mge.2003.54.
- Background: PubMed 20145607Rubio-Tapia A, Rahim MW, See JA, Lahr BD, Wu TT, Murray JA. Mucosal recovery and mortality in adults with celiac disease after treatment with a gluten-free diet. Am J Gastroenterol. 2010 Jun;105(6):1412-20. doi: 10.1038/ajg.2010.10. Epub 2010 Feb 9.
- Background: PubMed 9042988Bai JC, Gonzalez D, Mautalen C, Mazure R, Pedreira S, Vazquez H, Smecuol E, Siccardi A, Cataldi M, Niveloni S, Boerr LA, Maurino E. Long-term effect of gluten restriction on bone mineral density of patients with coeliac disease. Aliment Pharmacol Ther. 1997 Feb;11(1):157-64. doi: 10.1046/j.1365-2036.1997.112283000.x.
- Background: PubMed 11943958Dickey W. Low serum vitamin B12 is common in coeliac disease and is not due to autoimmune gastritis. Eur J Gastroenterol Hepatol. 2002 Apr;14(4):425-7. doi: 10.1097/00042737-200204000-00016.
- Background: PubMed 18496230Halfdanarson TR, Kumar N, Hogan WJ, Murray JA. Copper deficiency in celiac disease. J Clin Gastroenterol. 2009 Feb;43(2):162-4. doi: 10.1097/MCG.0b013e3181354294.
- Background: PubMed 15232359Kotze LM. Gynecologic and obstetric findings related to nutritional status and adherence to a gluten-free diet in Brazilian patients with celiac disease. J Clin Gastroenterol. 2004 Aug;38(7):567-74. doi: 10.1097/01.mcg.0000131720.90598.6a.
- Background: PubMed 21682114Choi JM, Lebwohl B, Wang J, Lee SK, Murray JA, Sauer MV, Green PH. Increased prevalence of celiac disease in patients with unexplained infertility in the United States. J Reprod Med. 2011 May-Jun;56(5-6):199-203.
- Background: PubMed 19939833Khashan AS, Henriksen TB, Mortensen PB, McNamee R, McCarthy FP, Pedersen MG, Kenny LC. The impact of maternal celiac disease on birthweight and preterm birth: a Danish population-based cohort study. Hum Reprod. 2010 Feb;25(2):528-34. doi: 10.1093/humrep/dep409. Epub 2009 Nov 24.
- Background: PubMed 17209192Catassi C, Fabiani E, Iacono G, D'Agate C, Francavilla R, Biagi F, Volta U, Accomando S, Picarelli A, De Vitis I, Pianelli G, Gesuita R, Carle F, Mandolesi A, Bearzi I, Fasano A. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr. 2007 Jan;85(1):160-6. doi: 10.1093/ajcn/85.1.160.
- Background: PubMed 18671779Haines ML, Anderson RP, Gibson PR. Systematic review: The evidence base for long-term management of coeliac disease. Aliment Pharmacol Ther. 2008 Nov 1;28(9):1042-66. doi: 10.1111/j.1365-2036.2008.03820.x. Epub 2008 Jul 30.
Related trials for Adult Form of Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
Efficacy of Symprove Probiotics in Coeliac Disease
Coeliac Disease, Probiotic
RecruitingObservational study
Study of the NATURal History, Epidemiological, Clinical, Diagnostic and Therapeutic Aspects of CELiac Disease and Non-celiac Enteropathies
Celiac Disease
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.
Anthony J. DiMarino, MD principal investigator
Thomas Jefferson University, Philadelphia, PA 19107
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Adult Form of Celiac Disease, run by Thomas Jefferson University 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 1 inclusion and 8 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 19 Jul 2019. 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 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?
1) Change in the patient estimated gluten intake after administration of study pills using the Celiac Dietary Adherence Test (CDAT), to be assessed at the end of follow up week 12 (time frame: up to follow up week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389062, which also lists 28 linked publications.
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 19 Jul 2019.