Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07360106

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

Led by Sheffield Teaching Hospitals NHS Foundation Trust · Updated on 2026-03-17

24

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Coeliac Disease (CD) is a lifelong autoimmune condition where eating gluten causes damage to the small intestine. Although most people improve on a strict gluten-free diet, up to 20% continue to experience gut symptoms like bloating, pain, and diarrhoea even after their intestine has healed. This study evaluates whether a probiotic drink called Symprove, containing live good bacteria, can help relieve these ongoing symptoms by restoring a healthy balance of gut bacteria. Participants will take 70 mL of Symprove orally every day for 3 months, with an optional fourth month if they complete all assessments. Symprove is gluten-free, dairy-free, and contains specific strains of Lactobacillus and Bifidobacterium. This single-arm, open-label study involves self-administration of the probiotic at home to test its effects on gut symptoms and microbiota balance. During the study, participants’ gut symptoms will be assessed monthly, and their quality of life and gut bacteria diversity will be measured at the start and end of the 3-month period. Stool samples will be collected to analyze gut bacteria changes. The study aims to understand if Symprove can reduce symptoms and improve life for adults with coeliac disease in remission who still have digestive issues.

CONDITIONS

Brief Title

Efficacy of Symprove Probiotics in Coeliac Disease

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-65 years with biopsy-confirmed coeliac disease
  • Normal duodenal biopsy (Marsh 0 or Marsh I) within the last 12 months confirming histological remission
  • Following a strict gluten-free diet for at least 6 months
  • Persistent gastrointestinal symptoms for at least 6 months despite gluten-free diet and histological remission
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Active gluten ingestion or not adhering to a gluten-free diet
  • Use of antibiotics within the past 3 months
  • Use of probiotics within the past 3 months
  • Known gastrointestinal comorbidities such as Crohn's disease, ulcerative colitis, or severe irritable bowel syndrome
  • Pregnancy or breastfeeding
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months, with an optional additional month

Participants take 70 mL of Symprove probiotic orally once daily at home for 3 months, with an optional fourth month if all month-3 assessments are completed. This probiotic aims to rebalance gut microbiota and reduce persistent gastrointestinal symptoms.

Monthly visits at baseline, Month 1, Month 2, and Month 3

Trial Site Locations

Total: 1 location

1

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom, S57AU

Actively Recruiting

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Research Team

D

David S Sanders, MBChB, MD

A

Arkadeep Dhali, MBBS, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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