NCT07360106 Efficacy of Symprove Probiotics in Coeliac Disease
| NCT ID | NCT07360106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Condition | Coeliac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-01-29 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-01-29 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
David S Sanders, MBChB, MD
PRINCIPAL INVESTIGATOR
Sheffield Teaching Hospitals NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT07360106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Coeliac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07360106 currently recruiting?
Yes, NCT07360106 is actively recruiting participants. Contact the research team at david.sanders1@nhs.net for enrollment information.
Where is the NCT07360106 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom.
Who is sponsoring the NCT07360106 clinical trial?
NCT07360106 is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. The principal investigator is David S Sanders, MBChB, MD at Sheffield Teaching Hospitals NHS Foundation Trust. The trial plans to enroll 24 participants.