Non Celiac Gluten SensitivityNCGSNCT02936297
Gluten Ingestion Biomarkers in Patients w Gluten Sensitivity and Healthy Controls Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study
A study testing High dose Gluten and Low dose Gluten in people with Non Celiac Gluten Sensitivity, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Celiac Gluten Sensitivity
- What is being tested?
- High dose Gluten and Low dose Gluten
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age
- Patients willing to maintain gluten free diet for 6 weeks
Who cannot join
- Patients < 18 years of age
- Patients with positive serology suggestive of celiac disease and/or biopsy-proven celiac disease and/or Human leukocyte antigen (HLA) DQ2 or DQ8 positivity.
- Patients with a diagnosis of inflammatory bowel disease
- Patients with a diagnosis of acute gastroenteritis
- Patients who are pregnant
- Type 1 Diabetes Mellitus
Show all 13Show fewer
- NCGS
- Celiac disease
- Inflammatory bowel disease
- Irritable bowel syndrome
- Acute gastroenteritis
- Patients who are pregnant
- Type 1 Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Quantitative Measurement of Stool and Urine Gluten Immunogenic Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study Study
Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The pathologic mechanism of the disorder is unknown, and there are no known biomarkers or associated histopathologic findings. In this prospective, randomized controlled trail, we are investigating the utility of patient reported symptom questionnaires, as well as stool gluten and urine quantification tools in patients with NCGS and healthy controls.
- Conditions
- Non Celiac Gluten Sensitivity
- Being tested
- High dose Gluten, Low dose Gluten, Lactose free placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose GlutenDietary supplement
Low dose GlutenDietary supplement
Lactose free placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Lactose free placebo | Placebo comparator | Lactose free placebo pill Receives: Dietary Supplement: Lactose free placebo |
| Low dose Gluten (0.5g) | Active comparator | Low dose gluten pill Receives: Dietary Supplement: Low dose Gluten |
| High Dose Gluten (2.0g) | Active comparator | High dose gluten pill Receives: Dietary Supplement: High dose Gluten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT)
Measured: 12 weeks
NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD
Measured: 12 weeks
Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.
Measured: 12 weeks
Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD
Measured: 12 weeks
Patient Estimation of Gluten Intake captured via (PEGI) questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Celiac Gluten SensitivityStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936297
- Sponsor's protocol ID
- IRB#16D.244
- Acronym
- NCGS
- Status last verified
- Mar 2020
- First submitted
- 2 Sep 2016
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Measurement of Stool and Urine Gluten Immunogenic Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study Study
- ClinicalTrials.gov ID
- NCT02936297
- Acronym / sponsor ID
- NCGS / IRB#16D.244
- Conditions
- Non Celiac Gluten Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 18 Oct 2016 (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.
Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The pathologic mechanism of the disorder is unknown, and there are no known biomarkers or associated histopathologic findings. In this prospective, randomized controlled trail, we are investigating the utility of patient reported symptom questionnaires, as well as stool gluten and urine quantification tools in patients with NCGS and healthy controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lactose free placebo | Placebo comparator | Dietary Supplement: Lactose free placeboLactose free placebo pill |
| Low dose Gluten (0.5g) | Active comparator | Dietary Supplement: Low dose GlutenLow dose gluten pill |
| High Dose Gluten (2.0g) | Active comparator | Dietary Supplement: High dose GlutenHigh dose gluten pill |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients > 18 years of age
- Patients willing to maintain gluten free diet for 6 weeks
Key exclusion criteria (13 listed)
- Patients < 18 years of age
- Patients with positive serology suggestive of celiac disease and/or biopsy-proven celiac disease and/or Human leukocyte antigen (HLA) DQ2 or DQ8 positivity.
- Patients with a diagnosis of inflammatory bowel disease
- Patients with a diagnosis of acute gastroenteritis
- Patients who are pregnant
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 |
|---|---|---|
| High dose Gluten | Dietary supplement | High Dose Gluten (2.0g) |
| Low dose Gluten | Dietary supplement | Low dose Gluten (0.5g) |
| Lactose free placebo | Dietary supplement | Lactose free placebo |
Primary outcome
Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT)
Time frame: 12 weeks
NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD
Time frame: 12 weeks
Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.
Time frame: 12 weeks
Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD
Time frame: 12 weeks
Patient Estimation of Gluten Intake captured via (PEGI) questionnaire
Time frame: 12 weeks
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 11 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose Gluten and Low dose Gluten in people with Non Celiac Gluten Sensitivity, 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 2 inclusion and 13 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 11 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT) (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2020.