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临床试验/NCT07360106
NCT07360106招募中不适用

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

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年1月29日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Change in Gastrointestinal Symptom Scores

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Symprove Probiotic (Dietary Supplement)

结局指标

主要结局

Change in Gastrointestinal Symptom Scores

时间窗: 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)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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