Идёт набор NCT07360106

Efficacy of Symprove Probiotics in Coeliac Disease

Без фазы С лечением Coeliac Disease Probiotic Gluten

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Symprove Probiotic.
Кому может быть актуально: Состояния в реестре: Coeliac Disease, Probiotic, Gluten. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Пищевая добавка Symprove Probiotic
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 rebalanc

Первичные конечные точки

Change in Gastrointestinal Symptom Scores [Срок оценки: Assessed monthly at baseline, Month 1, Month 2, and Month 3]

Вторичные конечные точки (2)

Change in Quality of Life (EQ-5D Scores) [Срок оценки: Assessed at baseline and Month 3 (change from baseline to 3 months)]
Change in Gut Microbiota Diversity [Срок оценки: Assessed at baseline (Month 0) and Month 3]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет