Efficacy of Symprove Probiotics in Coeliac Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Symprove Probiotic.
- Who it may be relevant to
- Registry conditions: Coeliac Disease, Probiotic, Gluten. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Dietary supplement Symprove Probiotic
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 rebalanc
Primary outcome measures
- Change in Gastrointestinal Symptom Scores [Time frame: Assessed monthly at baseline, Month 1, Month 2, and Month 3]
Secondary outcome measures (2)
- Change in Quality of Life (EQ-5D Scores) [Time frame: Assessed at baseline and Month 3 (change from baseline to 3 months)]
- Change in Gut Microbiota Diversity [Time frame: Assessed at baseline (Month 0) and Month 3]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield
Identifiers
NCT: NCT07360106 · STH23479