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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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Contact Information
Primary
David S Sanders, MBChB, MD
david.sanders1@nhs.net
0114 271 3412
Backup
Arkadeep Dhali, MBBS, MPH
a.dhali@nhs.net
Time Frame
Start Date: 2026-01-29
Estimated Completion Date: 2026-12
Participants
Target number of participants: 24
Treatments
Experimental: Symprove Probiotic
All participants will receive a daily oral dose of 70 mL Symprove probiotic supplement for 3 months, with an optional fourth month contingent on completion of all study assessments at month 3. Symprove is a gluten-free, dairy-free probiotic formulation containing live Lactobacillus and Bifidobacterium strains. Participants will self-administer the probiotic daily at home. This is a single-arm, open-label, proof-of-concept study.
Related Therapeutic Areas
Sponsors
Leads: Sheffield Teaching Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov