Coeliac DiseaseNCT07360106
Efficacy of Symprove Probiotics in Coeliac Disease
A study testing Symprove Probiotic in people with Coeliac Disease and Probiotic, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coeliac Disease, Probiotic, Gluten
- What is being tested?
- Symprove Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arkadeep Dhali, MBBS, MPH contact
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S57AU
Jemima Clarke, 01142265943, sth.researchadministration@nhs.net
David S Sanders, MBChB, MD
About this study
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
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).
Read more
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
- Being tested
- Symprove Probiotic
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symprove ProbioticDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Symprove Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Assessed monthly at baseline, Month 1, Month 2, and Month 3
Secondary outcomes (2)
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)
Measured: 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)
Measured: Assessed at baseline (Month 0) and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start29 Jan 2026
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coeliac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S Sanders, MBChB, MD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360106
- Sponsor's protocol ID
- STH23479
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07360106
- Acronym / sponsor ID
- STH23479
- Conditions
- Coeliac Disease, Probiotic, Gluten
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Symprove Probiotic | Experimental | Dietary Supplement: Symprove ProbioticAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symprove ProbioticSymprove 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. | Dietary supplement | Symprove Probiotic |
Primary outcome
Change in Gastrointestinal Symptom Scores
Time frame: Assessed monthly at baseline, Month 1, Month 2, and Month 3
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)
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arkadeep Dhali, MBBS, MPH contact
David S Sanders, MBChB, MD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symprove Probiotic in people with Coeliac Disease and Probiotic, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David S Sanders, MBChB, MD (0114 271 3412, david.sanders1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastrointestinal Symptom Scores (time frame: Assessed monthly at baseline, Month 1, Month 2, and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.