Innovative Trials are passionate about ensuring our diverse population is adequately represented within medical research. Whether it is wanting to see more people from underrepresented communities choosing science as a career and pushing for greater patient diversity in clinical trials or focusing on what we are doing internally to celebrate and promote equality and diversity, this month we celebrate World Thyroid Day 2025. So far the Equality, Diversity, and Inclusion Committee at Innovative Trials has written blogs to raise awareness surrounding several illnesses, their effects, and treatments such as World Lupus Day, Malaria, Pride Month, Endometriosis, Pancreatic Cancer Awareness Month, Parent Mental Health Day, International Day of Women and Girls in Science, International Childhood Cancer Day , Sickle Cell and Rare Diseases, Multiple Myeloma Action Month, Ramadan & Eid-ul-Fitr 2025 and World Thyroid Day 2025.

What is Celiac Disease?

Celiac disease is a genetic autoimmune disorder. When someone with celiac disease ingests gluten, a protein found in wheat, barley, and rye, the immune system attacks the gluten and damages the healthy tissue on the surface of the small intestine. This damage prevents the small intestine from properly absorbing nutrients from food, often resulting in vitamin and nutrient deficiencies. (Coeliac UK, 2025)

 

About 1 in 100 people worldwide have celiac disease (Coeliac UK, 2025)

 

 

On average, it takes 6-10 years for an accurate diagnosis (Beyond Celiac, 2025)

 

What Treatments are there for Celiac Disease?

 

There are no medical treatments for celiac disease

 

 

The only treatment option is to adhere to a lifelong gluten-free diet

 

 

50% of patients still experience symptoms on a gluten-free diet

 

While there are no medicines or cures for celiac disease, doctors may recommend to celiac patients certain treatments to help manage their symptoms:

  • Supplements to manage vitamin and nutrient deficiencies
  • Antibiotics for dermatitis herpetiformis
  • Corticosteroids for patients experiencing severe small intestinal inflammation (Coeliac UK, 2025) 

How are People Affected by Celiac Disease?

Celiac disease is a chronic disease so those who have been diagnosed will have celiac disease for the rest of their lives.

 

There are over 200 symptoms associated with celiac disease

 

 

Celiac disease can affect every organ in the body

 

Common symptoms related to the digestive system: diarrhea, weight loss, abdominal pain, nausea, vomiting, constipation, bloating, and gas.

Common symptoms not related to the digestive system: anxiety, depression, headaches, fatigue, skin rashes, weak bones, mouth ulcers, joint pain.
(Mayo Clinic, 2025)

What Increases Your Risk of Celiac Disease?

  • A blood relative with celiac disease increases your chance of developing it to 1 in 10 
  • A diagnosis of another autoimmune disease (eg, Type 1 Diabetes)
  • A diagnosis of Down Syndrome or Turner Syndrome 
  • Stress
  • Pregnancy and Childbirth
  • Surgery

(Celiac Disease Foundation, 2025, & John Hopkins Medicine, 2025)

What are Some Long-Term Complications of Celiac Disease?

  • Anemia. The malabsorption of iron, folate, and vitamin B12 can cause lower red blood cell levels, as these nutrients are essential for red blood cell production. 
  • Dermatitis Herpetiformis. A blistery skin disease, with rashes occurring usually in the scalp, torso, elbows, knees and/or buttocks.
  • Osteoporosis. The malabsorption of calcium and vitamin D can soften bone tissue and lead to a loss in bone density. 
  • Infertility. The malabsorption of calcium and vitamin D can contribute to issues in reproduction, including an increased risk of miscarriage. 
  • Cancer. Celiac patients who do not follow a strict gluten-free diet have a greater risk of intestinal and bowel cancers. 
  • Immune Diseases. Type I Diabetes, Thyroid disease and Sjögren’s disease (dry eyes, dry mouth, fatigues and neuropathies)

(John Hopkins Medicine, 2025 & Beyond Celiac, 2025)

Our Clinical Trial Experience

Innovative Trials has supported two studies for celiac disease with our Recruitment and Retention Materials service. Between these studies we have:

 

Developed 38 patient and site-facing materials

 

 

Translated materials into 16 languages

 

 

Supported sites in 9 countries

 

Here are some of the key challenges we experience when boosting recruitment for celiac disease clinical trials, and suggestions on how to overcome these for your studies:

  • Requiring participants to consume gluten. Participants may need to consume gluten in the studies to measure whether the study treatment is working. However, this could deter potential participants, as a strict gluten-free diet may be the only way they are able to manage their symptoms. 
  • Our recommendation – Explain the purpose of gluten consumption and emphasize the close monitoring that participants will receive from the study team during their participation in the trial.
  • Gastrointestinal biopsies. Participants may be required to have these assessments to monitor their small intestine tissue, to help determine whether the study medicine prevents damage to the small intestine upon the consumption of gluten. 
  • Our recommendation – Consider developing a material that details the procedure with a frequently asked questions section. Participants may feel better about the procedure if they know exactly what to expect.
  • Anxiety and depression. These are two common symptoms of celiac disease, which might contribute to potentially eligible patients feeling apprehensive about joining your clinical trial. 
  • Our recommendation – Consider introducing support sessions, for participants to discuss any study concerns at their visits and work with the study team to find potential solutions, helping to retain participants in your trial.
  • Frequent study visits. Celiac disease studies are likely to have intense visit schedules, with frequent blood tests to gather pharmacokinetic information about the study medicine, which may be difficult for the participant to fit around school or work. 
  • Our recommendation – Consider developing letters that the study team may address to the participant’s school or work explaining the importance of the study and for the participant to attend visits. 

 

References