Efficacy of Symprove Probiotics in Coeliac Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coeliac Disease; Gluten; Probiotic
• Intervention / Treatment: Dietary supplement: Symprove Probiotic

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David S Sanders, MBChB, MD; Phone Number: 0114 271 3412; Email: david.sanders1@nhs.net
• Study Contact Backup: Name: Arkadeep Dhali, MBBS, MPH; Email: a.dhali@nhs.net

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S57AU
      • Recruiting
      • Sheffield Teaching Hospitals NHS Foundation Trust
      • Contact: Jemima Clarke; Phone Number: 01142265943; Email: sth.researchadministration@nhs.net
      • Principal Investigator: David S Sanders, MBChB, MD
      • Sub-Investigator: Arkadeep Dhali, MBBS, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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 rebalance gut microbiota dysbiosis and reduce persistent gastrointestinal symptoms in coeliac disease patients in histological remission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gastrointestinal Symptom Scores	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)	Assessed monthly at baseline, Month 1, Month 2, and Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life (EQ-5D Scores)	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)	Assessed at baseline and Month 3 (change from baseline to 3 months)
Change in Gut Microbiota Diversity	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)	Assessed at baseline (Month 0) and Month 3

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: David S Sanders, MBChB, MD, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Nutritional and Metabolic Diseases; Celiac Disease
• Other Study ID Numbers: STH23479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) that underlie published results will be made available to researchers upon reasonable request following completion of the trial and publication of the main findings. Data will be stored securely and released only with appropriate approvals, in accordance with the Data Protection Act 2018 and Sheffield Teaching Hospitals NHS Trust policies. Requests for access may come from both internal and external research collaborators, and all IPD will be stripped of direct patient identifiers prior to sharing.
• IPD Sharing Time Frame: Once main finding and results have been published
• IPD Sharing Access Criteria: Applications for access will be assessed by the CI and investigator team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No