Actively Recruiting
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
Led by Sheffield Teaching Hospitals NHS Foundation Trust · Updated on 2026-03-17
24
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Coeliac Disease (CD) is a lifelong autoimmune condition where eating gluten causes damage to the small intestine. Although most people improve on a strict gluten-free diet, up to 20% continue to experience gut symptoms like bloating, pain, and diarrhoea even after their intestine has healed. This study evaluates whether a probiotic drink called Symprove, containing live good bacteria, can help relieve these ongoing symptoms by restoring a healthy balance of gut bacteria. Participants will take 70 mL of Symprove orally every day for 3 months, with an optional fourth month if they complete all assessments. Symprove is gluten-free, dairy-free, and contains specific strains of Lactobacillus and Bifidobacterium. This single-arm, open-label study involves self-administration of the probiotic at home to test its effects on gut symptoms and microbiota balance. During the study, participants’ gut symptoms will be assessed monthly, and their quality of life and gut bacteria diversity will be measured at the start and end of the 3-month period. Stool samples will be collected to analyze gut bacteria changes. The study aims to understand if Symprove can reduce symptoms and improve life for adults with coeliac disease in remission who still have digestive issues.
CONDITIONS
Brief Title
Efficacy of Symprove Probiotics in Coeliac Disease
Who Can Participate
Eligibility Criteria
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 histological remission
- Ability to provide written informed consent
You will not qualify if you...
- Active gluten ingestion or not adhering to a gluten-free diet
- Use of antibiotics within the past 3 months
- Use of probiotics within the past 3 months
- Known gastrointestinal comorbidities such as Crohn's disease, ulcerative colitis, or severe irritable bowel syndrome
- Pregnancy or breastfeeding
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months, with an optional additional month
Participants take 70 mL of Symprove probiotic orally once daily at home for 3 months, with an optional fourth month if all month-3 assessments are completed. This probiotic aims to rebalance gut microbiota and reduce persistent gastrointestinal symptoms.
Monthly visits at baseline, Month 1, Month 2, and Month 3
Trial Site Locations
Total: 1 location
1
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S57AU
Actively Recruiting
Research Team
D
David S Sanders, MBChB, MD
A
Arkadeep Dhali, MBBS, MPH
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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