Celiac DiseaseNCT00931892
Serum Markers in Gluten Challenge
A study testing Gluten in people with Celiac Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 72 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Gluten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 to 72 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
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: Circulating Markers of Celiac Disease Activity During Gluten Challenge - a Pilot Study.
- 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.
- 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.
Read the detailed description
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.
- Conditions
- Celiac Disease
- Being tested
- Gluten
- Keywords
- celiac disease, gluten challenge
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutenDietary supplement
3g
GlutenDietary supplement
10g
| Study group | Role | What they receive |
|---|---|---|
| Low gluten group | Experimental | Subjects will eat 3g of gluten per day Receives: Dietary Supplement: Gluten |
| High gluten group | Experimental | Subjects will eat 10g of gluten per day Receives: Dietary Supplement: Gluten |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening (Day -7 to -14), Day 3, Day 14
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciaran Kelly, Beth Israel Deaconess Medical Center
- Investigators
- Ciaran P Kelly, MD, Principal investigator, Beth Israel Deaconess Medical CenterDaniel A Leffler, MD, MS, Study director, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931892
- Sponsor's protocol ID
- 2007P000280
- Other IDs
- K23DK082619
- Status last verified
- May 2021
- First submitted
- 30 Jun 2009
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 3123181Adelman 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.
PubMed 29460921Leffler 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.
PubMed 19665584Leffler 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.
PubMed 22619366
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Markers of Celiac Disease Activity During Gluten Challenge - a Pilot Study.
- ClinicalTrials.gov ID
- NCT00931892
- Acronym / sponsor ID
- 2007P000280
- Conditions
- Celiac Disease
- Keywords
- celiac disease, gluten challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2009 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 4 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low gluten group | Experimental | Dietary Supplement: GlutenSubjects will eat 3g of gluten per day |
| High gluten group | Experimental | Dietary Supplement: GlutenSubjects will eat 10g of gluten per day |
Who may qualify
- Ages
- 17 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Gluten3g | Dietary supplement | Low gluten group |
| Gluten10g | Dietary supplement | High gluten group |
Primary outcome
Crypt Depth to Villous Height Ratio
Time frame: Screening (Day -7 to -14), Day 3, Day 14
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.
7 secondary outcomes
Count of Intraepithelial Lymphocytes Per 100 Enterocytes in Duodenal Biopsy Samples
Time frame: Screening (Day -7 to -14), Day 3, Day 14
Measures of Intestinal Permeability (Urinary Lactulose to Mannitol Ratio)
Time frame: Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28
Measures of Immune Activation
Time frame: Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28
Assessment of Protein Expression in Intestinal Biopsies
Time frame: Screening (Day -7 to -14), Day 3, Day 14
Symptomatic Response to Gluten Exposure Determined by Celiac Symptom Index Questionnaire
Time frame: 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
Time frame: Screening (Day -7 to -14), Day 3, Day 14
Symptomatic Response to Gluten Exposure Determined by Gastrointestinal Symptom Rating Scale
Time frame: Screening (Day -7 to -14), Day 0, Day 3, Day 7, Day 14, Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3123181Svedlund 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.
- Results publication: PubMed 29460921Adelman 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.
- Results publication: PubMed 19665584Leffler 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.
- Derived from this study: PubMed 22619366Leffler 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.
- BIDMC Celiac Center Research websiteLink provided by the sponsor.
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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.
Ciaran P Kelly, MD principal investigator
Beth Israel Deaconess Medical Center
Daniel A Leffler, MD, MS study director
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, 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: finished, as of the sponsor's last update on 4 Jun 2021. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Crypt Depth to Villous Height Ratio (time frame: Screening (Day -7 to -14), Day 3, Day 14). 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 NCT00931892, which also lists 4 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 4 Jun 2021.