Efficacy of Symprove Probiotics in Coeliac Disease

NCT07360106 | Recruiting

• 1 other identifier: STH23479
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Coeliac Disease; Probiotic; Gluten

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Quality of Life (EQ-5D Scores)

  Assessed at baseline and Month 3 (change from baseline to 3 months)

• Change in Gut Microbiota Diversity

  Assessed at baseline (Month 0) and Month 3

Study Arms (1)

Symprove Probiotic

EXPERIMENTAL

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

Interventions

Symprove Probiotic DIETARY_SUPPLEMENT

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.

Symprove Probiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S57AU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David S Sanders, MBChB, MD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David S Sanders, MBChB, MD

CONTACT

0114 271 3412; david.sanders1@nhs.net

Arkadeep Dhali, MBBS, MPH

CONTACT

a.dhali@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, open-label, proof-of-concept study evaluating the efficacy of Symprove probiotics in managing persistent gastrointestinal symptoms in adult coeliac disease patients in histological remission. All participants will receive daily Symprove supplementation for 3 months, with assessments at baseline and monthly intervals.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Once main finding and results have been published
• Access Criteria: Applications for access will be assessed by the CI and investigator team.

Locations

GB (1)