Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07360106

Efficacy of Symprove Probiotics in Coeliac Disease

Led by Sheffield Teaching Hospitals NHS Foundation Trust · Updated on 2026-03-17

24

Participants Needed

1

Research Sites

43 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy of Symprove Probiotics in Coeliac Disease

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-65 years with biopsy-confirmed coeliac disease
  • Normal duodenal biopsy (Marsh 0 or Marsh I) within the last 12 months confirming histological remission
  • Following a strict gluten-free diet for at least 6 months
  • Persistent gastrointestinal symptoms for at least 6 months despite gluten-free diet and remission
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Active gluten ingestion or not following a gluten-free diet
  • Use of antibiotics in the past 3 months
  • Use of probiotics in the past 3 months
  • Known gastrointestinal disorders like Crohn's disease, ulcerative colitis, or severe irritable bowel syndrome
  • Pregnancy or breastfeeding
  • Inability to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom, S57AU

Actively Recruiting

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Research Team

D

David S Sanders, MBChB, MD

CONTACT

A

Arkadeep Dhali, MBBS, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Efficacy of Symprove Probiotics in Coeliac Disease | DecenTrialz