Efficacy of Symprove Probiotics in Coeliac Disease

Recruiting now · Not applicable

Conditions studied: Coeliac Disease, Probiotic, Gluten

In brief

Coeliac Disease (CD) is a lifelong autoimmune condition where eating gluten (a protein found in wheat, barley, and rye) causes damage to the small intestine. It affects around 1 in 100 people. Most individuals feel better and their gut heals after switching to a strict gluten-free diet. However, up to 1 in 5 people with coeliac disease continue to experience unpleasant gut symptoms-such as bloating, pain, and diarrhoea-despite following the diet and having a healed intestine. These ongoing symptoms can be very distressing and impact daily life. This study investigates whether a food supplement called Symprove, a probiotic drink containing live good bacteria, can help relieve these ongoing symptoms. Scientists believe that in some people with coeliac disease, the community of bacteria in the gut (called the microbiota) becomes unbalanced, even after going gluten-free. This imbalance (known as dysbiosis) may lead to inflammation, irritation, and symptoms similar to irritable bowel syndrome (IBS). The aim of this study is to test whether Symprove can help correct this imbalance and reduce symptoms. Participants will take Symprove daily and their symptoms, quality of life, and gut bacteria (measured from stool samples) will be monitored over time. The study hopes to answer three key questions: Can Symprove reduce gut symptoms in people with coeliac disease who are in remission? Does it work by restoring a healthy balance of gut bacteria? Are people with more severe imbalance (dysbiosis) more likely to have symptoms? If successful, this research could offer a safe, non-drug option to improve life for coeliac patients who continue to suffer symptoms despite avoiding gluten. It could also help suggest that gut bacteria play a role in ongoing symptoms and are a target for future treatment.

Key facts

Study ID

NCT07360106

Run by

Sheffield Teaching Hospitals NHS Foundation Trust

People needed

24

Starts

2026-01-29

Expected to finish

2026-12-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18-65 years with biopsy-confirmed coeliac disease (CD)
• Normal duodenal biopsy (Marsh 0 or Marsh I) within the last 12 months, confirming histological remission
• Adherence to a strict gluten-free diet (GFD) for at least 6 months
• Persistent gastrointestinal (GI) symptoms for at least 6 months despite adherence to GFD and histological remission
• Ability to provide written informed consent

You may not qualify if…

• Active gluten ingestion or non-adherence to a gluten-free diet
• Use of antibiotics within the past 3 months
• Use of probiotics within the past 3 months
• Known comorbidities affecting gastrointestinal function (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome with severe diarrhea, or other significant gastrointestinal disorders)
• Pregnancy or lactation
• Inability to provide informed consent

Where it is running

• Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, South Yorkshire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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