NCT Number: NCT07360106
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Sheffield, South Yorkshire, S57AU, United Kingdom
Location status: Recruiting
Arkadeep Dhali, MBBS, MPH
SUB_INVESTIGATOR
David S Sanders, MBChB, MD
PRINCIPAL_INVESTIGATOR
Jemima Clarke
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Symprove is a water-based, multi-strain probiotic food supplement containing live bacteria (Lactobacillus and Bifidobacterium strains). Participants will take 70 mL of Symprove orally once daily for 3 months (90 days total), with an optional fourth month available if participants complete all month-3 assessments. The probiotic will be provided free of charge to participants. Symprove is gluten-free and dairy-free, making it suitable for coeliac disease patients. The intervention aims to rebalance gut microbiota dysbiosis and reduce persistent gastrointestinal symptoms in coeliac disease patients in histological remission.
Time frame: Assessed monthly at baseline, Month 1, Month 2, and Month 3
Clinically significant reduction in gastrointestinal (GI) symptom scores, defined as a reduction of 50 points or more on validated GI symptom assessment scales (such as GSRS-IBS: Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome) from baseline. The GSRS-IBS assesses gastrointestinal symptoms including bloating, abdominal pain, diarrhea, and other bowel-related symptoms. A 50-point reduction is considered clinically meaningful. Higher scores indicate worse symptoms, so a reduction indicates improvement.
Unit of Measure:
GSRS-IBS total score (continuous variable)
Time frame: Assessed at baseline and Month 3 (change from baseline to 3 months)
Quality of life will be measured using the EQ-5D questionnaire, a standardized instrument that assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level scale, and responses are converted into a single index score representing overall health status. The change in EQ-5D index score from baseline (prior to intervention) to 3 months post-intervention will be calculated. Higher scores indicate better health-related quality of life.
Unit of Measure: EQ-5D index score (continuous variable)
Time frame: Assessed at baseline (Month 0) and Month 3
Changes in gut microbial diversity measured through stool sample analysis using 16S rRNA gene sequencing.
Gut microbial diversity will be assessed through stool sample analysis using 16S rRNA gene sequencing. Diversity will be quantified using standard ecological metrics. The outcome is the change in gut microbiota diversity from baseline (Month 0) to Month 3. Higher diversity is generally associated with improved gut health.
Unit of Measure: Diversity indices (e.g. observed species count)
Contact information is provided by the study sponsor or research team.
Arkadeep Dhali, MBBS, MPH
CONTACT
David S Sanders, MBChB, MD
CONTACT
Sheffield Teaching Hospitals NHS Foundation Trust
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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