Timing of Gluten-free Oats Introduction for Celiac Disease

Overseen By Ines Pinto-Sanchez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Removed oats, Oats allergy, Prior RD education, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the timing of introducing gluten-free oats affects individuals recently diagnosed with celiac disease. It compares starting gluten-free oats immediately after diagnosis to waiting six months, focusing on gut symptoms, nutrition, and quality of life. Participants will complete questionnaires and attend clinic visits to monitor their progress. This trial suits those diagnosed with celiac disease in the last three months who have not yet removed oats from their diet. As an unphased trial, it provides a unique opportunity to contribute to understanding dietary impacts on celiac disease management.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients receiving antibiotics or probiotics within a month can still participate, which suggests that some medications may be allowed.

What prior data suggests that gluten-free oats are safe for individuals with celiac disease?

Research has shown that specially made gluten-free oats are safe for people with celiac disease. Studies have found that these oats do not cause additional symptoms or worsen the condition. New findings confirm that adding gluten-free oats to a gluten-free diet does not affect celiac symptoms or the disease itself. Long-term studies suggest that most people with celiac disease can consume moderate amounts of gluten-free oats without issues. This evidence supports that gluten-free oats are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the timing of introducing gluten-free oats as part of a celiac disease diet. Unlike the standard gluten-free diet, which typically eliminates all forms of gluten-containing grains, this trial investigates whether introducing gluten-free oats either early or late after diagnosis can offer additional benefits. The interest lies in understanding if the timing of oats introduction can improve dietary tolerance and nutritional outcomes for those with celiac disease, potentially offering a more flexible and nutritious approach to managing the condition.

What evidence suggests that this trial's treatments could be effective for celiac disease?

Research shows that gluten-free oats are usually safe for most people with celiac disease. This trial will compare two approaches: introducing gluten-free oats early, within 3 months after diagnosis, and introducing them later, at 6 months after diagnosis. Studies have found that these oats do not cause extra symptoms or worsen the condition. Many people can consume moderate amounts of gluten-free oats without adverse reactions. Adding oats can also enhance the nutrition of a gluten-free diet, although some individuals may have concerns. Overall, gluten-free oats are often well-tolerated and could be a beneficial option for managing celiac disease. ^{2 4 5 6 7}

Who Is on the Research Team?

Jedid-Jah Blom, RD

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

This trial is for people who've been recently diagnosed with celiac disease, confirmed by specific blood tests and intestinal biopsies. They should have started a gluten-free diet within the last three months but haven't yet received detailed dietary guidance or removed oats from their diet.

Inclusion Criteria

I was diagnosed with celiac disease recently and have started a gluten-free diet.

Exclusion Criteria

I am willing and able to follow the study's procedures.

I have been educated on a gluten-free diet by a dietitian.

I have taken antibiotics or probiotics within the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either early or late introduction of gluten-free oats as part of a gluten-free diet

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of symptom control, nutritional status, and quality of life

3-6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Gluten-free Oats

Trial Overview The study is testing if introducing gluten-free oats early in the diet of new celiac patients affects gut symptoms, nutrition, celiac activity, and life quality differently than introducing them later. It's a small-scale pilot to prepare for a larger study.

How Is the Trial Designed?

Group I: Early introduction of gluten free oats Experimental Treatment 1 Intervention

Early introduction of oats (starting GF oats immediately after the diagnosis, within 3 months)

Group II: Late introduction of gluten free oats Active Control 1 Intervention

Late introduction of oats (starting GF oats 6 months after diagnosis of celiac disease)

Gluten-free Oats is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Gluten-Free Oats for:

• Celiac disease management

Approved in United States as Gluten-Free Oats for:

• Celiac disease management

Approved in Canada as Gluten-Free Oats for:

• Celiac disease management

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Recent evidence indicates that pure and uncontaminated oats can be safely consumed by most individuals with celiac disease, with recommended limits of up to 70 g per day for adults and 25 g for children.

The Canadian Celiac Association has established strict guidelines for the growing, processing, and testing of oats to ensure they meet gluten-free standards, leading to the availability of safe oat products for those with celiac disease in Canada.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of pure oats by individuals with celiac disease: a position statement by the Canadian Celiac Association. Rashid, M., Butzner, D., Burrows, V., et al.[2021]

A study involving 15 adults with celiac disease showed that consuming 350 g of pure oats per week for 12 weeks did not lead to any significant changes in symptoms or health markers, indicating that these oats are safe for this population.

All participants maintained negative tissue transglutaminase (tTG) levels and showed no significant histological changes in their duodenal biopsies, supporting the safety of pure oats produced under Canadian Celiac Association guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of clinical and histological safety of pure and uncontaminated Canadian oats in the management of celiac disease. Sey, MS., Parfitt, J., Gregor, J.[2015]

A study of 133 oat samples in Canada found that approximately 88% were contaminated with gluten from other grains, making them unsafe for people with celiac disease.

Only one gluten-free variety of oats tested negative for gluten contamination, highlighting the importance of choosing certified 'pure' oats for a safe gluten-free diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gluten contamination in the Canadian commercial oat supply. Koerner, TB., Cléroux, C., Poirier, C., et al.[2021]

Oats can be a beneficial addition to a gluten-free diet for celiac patients due to their high protein content and presence of essential nutrients, but they should only be introduced when patients are in remission.

There are significant concerns regarding the safety of oat consumption in celiac patients, including the risk of adverse reactions and the need for careful selection of oat varieties and monitoring for gluten contamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pros and Cons of Using Oat in a Gluten-Free Diet for Celiac Patients. Hoffmanová, I., Sánchez, D., Szczepanková, A., et al.[2020]

Regular oats in Canada are often contaminated with gluten, raising concerns for individuals with celiac disease, but pure, noncontaminated oats are generally considered safe for both adults and children.

Some oat cultivars may still provoke an immune response in sensitive individuals, highlighting the need for further long-term studies to identify safe oat varieties and better monitor their dietary intake in gluten-free diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pure Oats as Part of the Canadian Gluten-Free Diet in Celiac Disease: The Need to Revisit the Issue. de Souza, MC., Deschênes, ME., Laurencelle, S., et al.[2018]

The inclusion of oats in a gluten-free diet for celiac disease patients may not be as safe as previously thought, as many clinical trials may have inadvertently exposed participants to gluten contamination from oats, leading to adverse reactions.

Analysis of 12 oat feeding studies revealed that expected gluten exposure levels could trigger clinical effects in many celiac patients, suggesting the need for new trials using higher-purity gluten-free oats to accurately assess oat safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oat safety for celiac disease patients: theoretical analysis correlates adverse symptoms in clinical studies to contaminated study oats. Fritz, RD., Chen, Y.[2019]

A study involving 306 children with celiac disease found that pure nonreactive oats are a safe dietary option, showing no significant adverse effects over a 15-month period.

Despite the safety of oats, the trial did not demonstrate any significant clinical or serological benefits in terms of symptoms or intestinal health when compared to a placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial. Lionetti, E., Gatti, S., Galeazzi, T., et al.[2019]

In a study of 869 celiac patients on a strict gluten-free diet, those who included non-contaminated oats showed no significant differences in symptoms, dietary adherence, or health complications compared to those who did not consume oats, indicating that oats can be safely included in their diet.

Oat consumers reported better quality of life scores, particularly in physical role limitations and general health, suggesting that including oats may enhance the overall well-being of celiac patients on a gluten-free diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Long-Term Consumption of Oats in Celiac Disease Patients Is Safe: A Large Cross-Sectional Study. Aaltonen, K., Laurikka, P., Huhtala, H., et al.[2018]

In a study of 39 coeliac disease patients, those consuming a gluten-free diet with oats experienced more gastrointestinal symptoms, particularly increased diarrhea and constipation, compared to those on a traditional gluten-free diet.

Despite the increase in symptoms, the mucosal integrity of the intestines remained intact, and antibody levels did not rise, suggesting that while oats can be included in a gluten-free diet, patients should be cautious of potential digestive discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an oats-containing gluten-free diet on symptoms and quality of life in coeliac disease. A randomized study. Peräaho, M., Kaukinen, K., Mustalahti, K., et al.[2019]

A study involving 710 patients with celiac disease and dermatitis herpetiformis found that 73% of celiac patients and 55% of dermatitis herpetiformis patients were currently consuming oats, indicating a positive adoption of oat-containing gluten-free diets since 1997.

While most patients appreciated oats for their taste and affordability, 15% of celiac disease patients and 28% of dermatitis herpetiformis patients stopped eating oats due to concerns about adverse effects or contamination, highlighting the need for safer oat products in the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oats can diversify a gluten-free diet in celiac disease and dermatitis herpetiformis. Peräaho, M., Collin, P., Kaukinen, K., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4904695/

Celiac Disease and Gluten-Free Oats: A Canadian Position ... Several long-term feeding studies have suggested that uncontaminated oats (i.e., gluten-free oats) are safe for the majority of patients with CD [15, 16]. Based ...

2. celiac.ca celiac.ca/living-gluten-free/oats-statement/

Oats However, specially produced gluten-free oats are safe for patients with celiac disease, with no evidence that they cause additional symptoms, changes in celiac ...

3. celiac.org celiac.org/gluten-free-oats-whats-the-deal/

Gluten-Free Oats: What's the Deal? Research continues to suggest that most individuals with celiac disease can tolerate moderate amounts of gluten-free oats without triggering adverse symptoms.

4. glutenfreewatchdog.org glutenfreewatchdog.org/news/oats-are-complicated-updated-position-statement-on-oats-from-gluten-free-watchdog/

Oats are complicated! Updated Position Statement on ... Gluten-free oats are available for folks with celiac disease and other gluten-related disorders. 4. Gluten-free oats may be either purity protocol or sorted.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4631980/

Role of oats in celiac disease - PMC While inclusion of oats in a gluten-free diet might improve its overall nutritional value, their use in such diets remains controversial. This review summarizes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10702567/

Gluten cross contact in oats: retrospective database ... It is long-established that oats are at substantial risk for cross contact with gluten-containing grain. Specially processed gluten-free oats, ...

7. gastrojournal.org gastrojournal.org/article/s0016-5085(17)35474-4/fulltext

Safety of Adding Oats to a Gluten-Free Diet for Patients ... New Findings. In our study, we found no evidence that addition of oats to a gluten-free diet affects symptoms or the activity of celiac disease.