Symprove probiotic for ongoing gut symptoms 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
This will try the Symprove probiotic drink to see if it reduces ongoing gut symptoms in adults with coeliac disease who are already following a strict gluten‑free diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Trial ID | NCT07360106 on ClinicalTrials.gov |
What this trial studies
This interventional trial gives the Symprove probiotic drink to adults with biopsy‑confirmed coeliac disease who are in histological remission but continue to have gastrointestinal symptoms. Eligible participants are aged 18–65, have a normal or near‑normal duodenal biopsy (Marsh 0 or I) within the past 12 months, and have followed a strict gluten‑free diet for at least six months. Participants will take the probiotic daily and symptom measures will be recorded before and after the treatment period to see if symptoms improve. Common exclusions include recent antibiotic or probiotic use, pregnancy or lactation, and other significant gastrointestinal disorders, and the trial is run at Sheffield Teaching Hospitals.
Who should consider this trial
Good fit: Adults 18–65 with biopsy‑confirmed coeliac disease in histological remission (Marsh 0 or I), on a strict gluten‑free diet for at least six months, and with persistent gastrointestinal symptoms for at least six months.
Not a fit: People who are pregnant or breastfeeding, recently used antibiotics or probiotics, have other major gastrointestinal diseases, are not adherent to a gluten‑free diet, or are outside the 18–65 age range are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, Symprove could reduce persistent gut symptoms and improve day‑to‑day quality of life for people with coeliac disease who remain symptomatic despite a gluten‑free diet.
How similar studies have performed: Probiotic treatments have produced mixed results in small trials for IBS‑type symptoms and have not been definitively proven for persistent symptoms in coeliac disease.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sheffield, South Yorkshire
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, South Yorkshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David S Sanders, MBChB, MD — Sheffield Teaching Hospitals NHS Foundation Trust
- Study coordinator: David S Sanders, MBChB, MD
- Email: david.sanders1@nhs.net
- Phone: 0114 271 3412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.