Celiac DiseaseNCT05803408
RCT: Effect of Late vs Early Introduction of Gluten-free Oats on Patients With Newly Diagnosed Celiac Disease.
A study testing gluten-free oats in people with Celiac Disease and Gluten Sensitivity, run by McMaster University at 1 site in Canada.
Trial summary
The investigators are conducting a pilot study to investigate the impact of late compared to early introduction of gluten-free oats on gut symptoms, nutrition status, celiac activity and quality of life in patients with a recent diagnosis of celiac disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease, Gluten Sensitivity, Gluten Allergy
- What is being tested?
- gluten-free oats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2023to May 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recent diagnosis of CeD (within 3 months of starting a GFD) based on specific CeD serology (elevated anti-tissue transglutaminase IgA, deaminated gliadin peptides IgG or anti-endomysial antibodies IgA) and confirmed by duodenal biopsies showing villous atrophy (Marsh 3a or greater). The allowance of 3 months is related to 1) the time lag between tTG and confirmatory EGD testing in clinical practice and 2) the time lag between diagnosis and dietitian assessment, which will increase likelihood of achieving a strict GFD.
Who cannot join
- Have already removed oats from the diet;
- History of allergic reaction to oats
- Prior assessment and education by RD on GFD
- Unwillingness or inability to commit to study procedures *Patients receiving antibiotics or probiotics within a month will be allowed to participate, however, this will be documented for future microbiota analysis.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster University Medical Center
Hamilton, Ontario, L8S2H1
Nicole Chang, MD
About this study
Official title: A Randomized Controlled Trial to Evaluate Effect of Late vs Early Introduction of Gluten-free Oats on Symptomatic, Serologic and Disease Activity in Patients With Newly Diagnosed Celiac Disease.
The investigators are conducting a pilot study to investigate the impact of late compared to early introduction of gluten-free oats on gut symptoms, nutrition status, celiac activity and quality of life in patients with a recent diagnosis of celiac disease. Pilot study means that it will recruit a low number of participants to see if it is possible to perform the study, and to estimate how many participants will be needed for the large study. The study will collect information through questionnaires that assess gut symptoms, quality of life, mood changes and dietary patterns. Moreover, the study will collect data on tests done during clinic visits to check the status of patients' celiac markers and nutritional status (such as vitamins and minerals). Physical exam will also take place, and include measurement of weight, BMI and body composition in a 3D scanner. The dietitian will analyze patients' diet at each visit during the study period. Given the lack of evidence on timing of introduction of gluten-free oats for patients with a recent celiac diagnosis, and the potential risks of limiting oats in a gluten-free diet, the results will hopefully lead to better understanding of whether one strategy has a benefit over the other.
Read the detailed description
Celiac disease (CeD) is a chronic inflammatory condition triggered by gluten in genetically predisposed individuals, manifesting with both intestinal and extra-intestinal symptoms. There is a relatively high prevalence of CeD in Western populations of around 1%. People with CeD have adverse immune-mediated reactions to gluten, which is the most abundant protein in many cereal grains, including wheat, rye, and barley. Currently, the only available treatment for CeD is a gluten-free diet (GFD). Gluten-free products are defined as containing less than 20 ppm of gluten, an international standard set by Codex Alimentarius Commission based on scientific data.
Oats are safe for most people with CeD, provided they are pure and uncontaminated with gluten. A small proportion of patients will react to avenin, the protein contained in oats, but this does not lead to intestinal inflammation. However, oats, including some brands labelled as gluten-free, are often contaminated with gluten, most notably from cross-contamination with wheat and barley due to agricultural practices. Furthermore, many patients remain symptomatic despite adhering to a GFD for different reasons, and concerns have been raised over whether continue eating oats to a GFD may contribute to persisting symptoms. For this reason, some experts in CeD recommend to delay the introduction of oats until 6 months after the diagnosis as part of a stabilization phase, after which the CeD is under better control and TTG autoantibody levels have decreased. However, there is no evidence this approach has any benefit over permitting the intake of GF oats from the time of diagnosis.
A GFD is restrictive and has been associated with nutritional deficiencies. Oats are highly nutritious and possess additional health benefits. They are an excellent source of macro- and micro-nutrients, including B complex vitamins, minerals, and heart-healthy soluble dietary fiber. These nutrients are essential in prevention of many chronic diseases such as diabetes and reducing cardiovascular risk factors. In addition, preliminary research suggests a benefit of oats on the gut microbiome.
Considering how rarely CeD patients react to oats and the numerous benefits of oats for nutrition and overall health, the delayed introduction of oats into the GFD, provided they are certified GF, has come under scrutiny. Given the lack of evidence that a delayed introduction of oats is beneficial for CeD patients and the potential risks of limiting oats in a GFD, there is an unmet need to understand the benefits of one approach over the other to provide recommendations for clinical practice.
This study proposes a pilot randomized controlled trial (RCT) to investigate the impact of late compared to early introduction of oats on gastrointestinal symptoms, nutritional status, disease activity and quality of life in patients with a recent diagnosis of CeD. The results of this study will provide the basis to plan an adequately powered RCT, and the results of the study will be highly relevant to guide recommendations in clinical practice on when oats should be introduced to patients with a CeD diagnosis.
- Conditions
- Celiac Disease, Gluten Sensitivity, Gluten Allergy, Gluten Enteropathy
- Being tested
- gluten-free oats
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gluten-free oatsOther
Early vs late introduction of gluten free oats
| Study group | Role | What they receive |
|---|---|---|
| Early introduction of gluten free oats | Experimental | Early introduction of oats (starting GF oats immediately after the diagnosis, within 3 months) Receives: Other: gluten-free oats |
| Late introduction of gluten free oats | Active comparator | Late introduction of oats (starting GF oats 6 months after diagnosis of celiac disease) Receives: Other: gluten-free oats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Better symptom control
To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving better symptom control (change in Celiac Disease Gastrointestinal Symptom Rating Scale scores; range 15-115; lower the score, the better the outcome) at 3- and 6-month follow-up
Measured: 3-6 months
tTG antibody levels
To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving:
Change in tTG antibody levels at 6-month follow-up
Measured: 6 months
improvement of nutritional status
To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving:
improvement of nutritional status (reduce % body fat mass)
Measured: 6 months
improvement in quality of life (change in Celiac Disease Quality of Life scores)
To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving:
improvement in quality of life (change in Celiac Disease Quality of Life scores, 20-100, lower the score better the outcome) at 3- and 6-month follow-up
Measured: 3-6 months
Food insecurity
Food insecurity will be assessed through Household Food Security Survey Module (HFSSM)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Ines Pinto Sanchez, McMaster University
- Investigators
- Jedid-Jah Blom, RD, Study director, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803408
- Sponsor's protocol ID
- 15964
- Status last verified
- Mar 2024
- First submitted
- 24 Jan 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate Effect of Late vs Early Introduction of Gluten-free Oats on Symptomatic, Serologic and Disease Activity in Patients With Newly Diagnosed Celiac Disease.
- ClinicalTrials.gov ID
- NCT05803408
- Acronym / sponsor ID
- 15964
- Conditions
- Celiac Disease, Gluten Sensitivity, Gluten Allergy, Gluten Enteropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 7 Apr 2023 (actual)
- 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.
The investigators are conducting a pilot study to investigate the impact of late compared to early introduction of gluten-free oats on gut symptoms, nutrition status, celiac activity and quality of life in patients with a recent diagnosis of celiac disease. Pilot study means that it will recruit a low number of participants to see if it is possible to perform the study, and to estimate how many participants will be needed for the large study. The study will collect information through questionnaires that assess gut symptoms, quality of life, mood changes and dietary patterns. Moreover, the study will collect data on tests done during clinic visits to check the status of patients' celiac markers and nutritional status (such as vitamins and minerals). Physical exam will also take place, and include measurement of weight, BMI and body composition in a 3D scanner. The dietitian will analyze patients' diet at each visit during the study period. Given the lack of evidence on timing of introduction of gluten-free oats for patients with a recent celiac diagnosis, and the potential risks of limiting oats in a gluten-free diet, the results will hopefully lead to better understanding of whether one strategy has a benefit over the other.
Detailed description
Celiac disease (CeD) is a chronic inflammatory condition triggered by gluten in genetically predisposed individuals, manifesting with both intestinal and extra-intestinal symptoms. There is a relatively high prevalence of CeD in Western populations of around 1%. People with CeD have adverse immune-mediated reactions to gluten, which is the most abundant protein in many cereal grains, including wheat, rye, and barley. Currently, the only available treatment for CeD is a gluten-free diet (GFD). Gluten-free products are defined as containing less than 20 ppm of gluten, an international standard set by Codex Alimentarius Commission based on scientific data.
Oats are safe for most people with CeD, provided they are pure and uncontaminated with gluten. A small proportion of patients will react to avenin, the protein contained in oats, but this does not lead to intestinal inflammation. However, oats, including some brands labelled as gluten-free, are often contaminated with gluten, most notably from cross-contamination with wheat and barley due to agricultural practices. Furthermore, many patients remain symptomatic despite adhering to a GFD for different reasons, and concerns have been raised over whether continue eating oats to a GFD may contribute to persisting symptoms. For this reason, some experts in CeD recommend to delay the introduction of oats until 6 months after the diagnosis as part of a stabilization phase, after which the CeD is under better control and TTG autoantibody levels have decreased. However, there is no evidence this approach has any benefit over permitting the intake of GF oats from the time of diagnosis.
A GFD is restrictive and has been associated with nutritional deficiencies. Oats are highly nutritious and possess additional health benefits. They are an excellent source of macro- and micro-nutrients, including B complex vitamins, minerals, and heart-healthy soluble dietary fiber. These nutrients are essential in prevention of many chronic diseases such as diabetes and reducing cardiovascular risk factors. In addition, preliminary research suggests a benefit of oats on the gut microbiome.
Considering how rarely CeD patients react to oats and the numerous benefits of oats for nutrition and overall health, the delayed introduction of oats into the GFD, provided they are certified GF, has come under scrutiny. Given the lack of evidence that a delayed introduction of oats is beneficial for CeD patients and the potential risks of limiting oats in a GFD, there is an unmet need to understand the benefits of one approach over the other to provide recommendations for clinical practice.
This study proposes a pilot randomized controlled trial (RCT) to investigate the impact of late compared to early introduction of oats on gastrointestinal symptoms, nutritional status, disease activity and quality of life in patients with a recent diagnosis of CeD. The results of this study will provide the basis to plan an adequately powered RCT, and the results of the study will be highly relevant to guide recommendations in clinical practice on when oats should be introduced to patients with a CeD diagnosis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early introduction of gluten free oats | Experimental | Other: gluten-free oatsEarly introduction of oats (starting GF oats immediately after the diagnosis, within 3 months) |
| Late introduction of gluten free oats | Active comparator | Other: gluten-free oatsLate introduction of oats (starting GF oats 6 months after diagnosis of celiac disease) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recent diagnosis of CeD (within 3 months of starting a GFD) based on specific CeD serology (elevated anti-tissue transglutaminase IgA, deaminated gliadin peptides IgG or anti-endomysial antibodies IgA) and confirmed by duodenal biopsies showing villous atrophy (Marsh 3a or greater). The allowance of 3 months is related to 1) the time lag between tTG and confirmatory EGD testing in clinical practice and 2) the time lag between diagnosis and dietitian assessment, which will increase likelihood of achieving a strict GFD.
Key exclusion criteria (4 listed)
- Have already removed oats from the diet;
- History of allergic reaction to oats
- Prior assessment and education by RD on GFD
- Unwillingness or inability to commit to study procedures *Patients receiving antibiotics or probiotics within a month will be allowed to participate, however, this will be documented for future microbiota analysis.
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 |
|---|---|---|
| gluten-free oatsEarly vs late introduction of gluten free oats | Other | Early introduction of gluten free oats, Late introduction of gluten free oats |
Primary outcome
Better symptom control
Time frame: 3-6 months
To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving better symptom control (change in Celiac Disease Gastrointestinal Symptom Rating Scale scores; range 15-115; lower the score, the better the outcome) at 3- and 6-month follow-up
tTG antibody levels
Time frame: 6 months
To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving: Change in tTG antibody levels at 6-month follow-up
improvement of nutritional status
Time frame: 6 months
To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving: improvement of nutritional status (reduce % body fat mass)
improvement in quality of life (change in Celiac Disease Quality of Life scores)
Time frame: 3-6 months
To assess the impact of late (after 6 months) vs early (immediate) introduction of gluten-free oats as part of a gluten-free diet on achieving: improvement in quality of life (change in Celiac Disease Quality of Life scores, 20-100, lower the score better the outcome) at 3- and 6-month follow-up
Food insecurity
Time frame: 6 months
Food insecurity will be assessed through Household Food Security Survey Module (HFSSM)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Jedid-Jah Blom, RD study director
Hamilton Health Sciences Corporation
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-free oats in people with Celiac Disease and Gluten Sensitivity, run by McMaster University at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Chang, MD (6476553177, nicole.chang@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Better symptom control (time frame: 3-6 months). 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 15 Mar 2024.