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Efficacy of Symprove Probiotics in Coeliac Disease

Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

NCT ID: NCT07360106

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Symprove Probiotic (supplement)
How long the study runs
Study runs about 11 months (dates as stated)
About the drug or intervention
Symprove Probiotic — supplement: Symprove is a water-based, multi-strain probiotic food supplement containing live bacteria (Lactobacillus and Bifidobacterium strains).
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
24
Started
2026-01-29
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for coeliac disease
  • • NA - 24 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with coeliac disease

Where?

  • • Sheffield - Sheffield Teaching Hospitals NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Coeliac DiseaseProbioticGluten

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Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

What the study is looking for

  • ✓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 agreement to take part

Who cannot take part

  • ✗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 other health conditions affecting gastrointestinal function (e.g., Crohn's disease, ulcerative colitis, irritable bowel...
  • ✗Pregnancy or lactation
See the full criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Is This Study? (1 UK site)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield S57AU, United Kingdom

Recruiting
Site contact (verified)
David S Sanders, MBChB, MDPrincipal Investigator

How to Get in Touch

David S Sanders, MBChB, MD

Sponsor contact

CONTACT

0114 271 3412 david.sanders1@nhs.net

Arkadeep Dhali, MBBS, MPH

Sponsor contact

CONTACT

a.dhali@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2026-03