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Efficacy of Symprove Probiotics in Coeliac Disease

Key facts

Who runs it
Sheffield Teaching Hospitals NHS Foundation Trust
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
24 people, planned
Started
29 Jan 2026
Expected to end
Dec 2026
Type of study
Interventional
Treatments tested
  • Symprove Probiotic
Record updated
17 March 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • Known comorbidities affecting gastrointestinal function (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome with severe diarrhea, or other significant gastrointestinal disorders)
  • 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
  • Pregnancy or lactation
  • Inability to provide informed consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The group in the trial

  • Symprove ProbioticTreatment being tested

    All participants will receive a daily oral dose of 70 mL Symprove probiotic supplement for 3 months, with an optional fourth month contingent on completion of all study assessments at month 3. Symprove is a gluten-free, dairy-free probiotic formulation containing live Lactobacillus and Bifidobacterium strains. Participants will self-administer the probiotic daily at home. This is a single-arm, open-label, proof-of-concept study.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Proof-of-Concept Study to Assess the Efficacy of Symprove Probiotics in Managing Persistent Gastrointestinal Symptoms in Adult Coeliac Disease Patients in Histological Remission
Fit questions
Built from NCT07360106, who can take part
Record updated
17 March 2026