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

Trial Summary

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 data supports the effectiveness of the treatment Gluten-free Oats, Pure Oats, Uncontaminated Oats, Specially Produced Gluten-Free Oats for Celiac Disease?

Research shows that long-term consumption of gluten-free oats is safe for people with celiac disease and may improve their quality of life. Studies indicate that oats can be a beneficial addition to a gluten-free diet, providing nutritional benefits without causing adverse effects when they are uncontaminated by gluten. ^{1 2 3 4 5}

Are gluten-free oats safe for people with celiac disease?

Pure, uncontaminated oats are generally considered safe for most people with celiac disease, but some individuals may still have reactions. It's important to ensure oats are truly gluten-free, as contamination with other grains like wheat can cause issues. ^{2 5 6 7 8}

How does the treatment of gluten-free oats differ from other treatments for celiac disease?

Gluten-free oats are unique because they are specially produced to avoid contamination with gluten from other grains, making them safe for most people with celiac disease. Unlike other treatments, they provide nutritional benefits like fiber and essential nutrients while adhering to a gluten-free diet. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Jedid-Jah Blom, RD

Principal Investigator

Hamilton Health Sciences Corporation

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Long-Term Consumption of Oats in Celiac Disease Patients Is Safe: A Large Cross-Sectional Study. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Oats can diversify a gluten-free diet in celiac disease and dermatitis herpetiformis. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Safety of Oats in Children with Celiac Disease: A Double-Blind, Randomized, Placebo-Controlled Trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Prospective study of clinical and histological safety of pure and uncontaminated Canadian oats in the management of celiac disease. [2015]

7. Egypt pubmed.ncbi.nlm.nih.gov

Pure Oats as Part of the Canadian Gluten-Free Diet in Celiac Disease: The Need to Revisit the Issue. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Pros and Cons of Using Oat in a Gluten-Free Diet for Celiac Patients. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Gluten contamination in the Canadian commercial oat supply. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Consumption of pure oats by individuals with celiac disease: a position statement by the Canadian Celiac Association. [2021]