Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity.
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: Probiotic Arm, Placebo Arm.
- Кому может быть актуально
- Состояния в реестре: Gut Inflammation, Overweight and Obese Volunteers. Базовые параметры: от 18 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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Обзор
Inflammatory bowel disease (IBD) affects over 6.8 million people worldwide, with current treatments often causing side effects and poor patient compliance. Dysbiosis of gut microbiota is a key factor, and while probiotics are considered safe and beneficial, conventional strains fail to function effectively during active inflammation due to high iron levels in the gut. Streptococcus thermophilus (FX856), unlike traditional probiotics, can thrive in this iron-rich environment, promoting mucosal healing. A 2-way crossover intervention study will be conducted with FX856 supplementation in overweight and obese individuals who often exhibit mild gut inflammation by measuring faecal calprotectin and systemic inflammatory markers.
Подробное описание
There is a lack of satisfactory treatments for inflammatory bowel disease (IBD), an excruciatingly debilitating condition which affects 1 in 123 people in the UK (\>0.5million). Current treatments have significant negative side effects, affecting quality of life of patients and reducing compliance, leading to exacerbation of symptoms. Dysbiosis in the composition of gut microbiota is one of the leading causes of chronic inflammatory diseases such as inflammatory bowel disease (IBD). Supplementation with dietary components is a promising approach for the treatment of inflammatory bowel disease (IBD) and the use of probiotics for IBD treatment has shown promising effects on consumers' quality of life, they are popular due to their perception as safe, natural treatments but currently marketed products cannot function during active disease. Streptococcus thermophilus (FX856) is an OTC supplement already available in the UK that has a unique ability to survive and thrive during active inflammation, allowing it to promote mucosal healing in the inflamed gut, an area where conventional probiotics have failed. During active inflammation or stress, gut iron levels increase. This iron-rich environment compromises the suitability of conventional probiotic bacteria that have been, and are still, commonly trailed for the relief of symptoms in patients suffering from gut inflammation. Whilst most constituents of the gut microbiome are able to increase growth rate in response to iron, species traditionally employed as probiotics, such as lactobacilli and bifidobacteria, are unable to use iron as a growth factor; they are outcompeted under high iron conditions and cannot have a beneficial effect. Unlike most bacterial strains used as probiotics, FX856 can maintain growth within an iron-rich environment, as observed in the inflamed intestine. Faecal calprotectin is considered a suitable non-invasive surrogate marker of intestinal inflammation in inflammatory bowel disease and is reported to be increased in obese individuals. Consequently, this study will determine how the probiotic FX856 interacts with the gut and immune system to reduce inflammation. A 2-way crossover intervention study will be conducted with FX856 (4 weeks) in an overweight and obese population, as such individuals are likely to have chronic mild gut inflammation and examine markers of faecal calprotectin and circulating inflammatory markers.
Вмешательства
- Пищевая добавка Probiotic Arm
1 x10\^9 cfu Streptococcus thermophilus (FX856), corn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule. - Пищевая добавка Placebo Arm
corn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule.
Первичные конечные точки
- Assess effects of FX856 on faecal calprotectin [Срок оценки: Change over 28 days comparison between treatments]
Вторичные конечные точки (11)
- Assess effect of FX856 treatment on gastrointestinal symptoms [Срок оценки: Change over 28 days comparison between treatments]
- Assess effect of FX856 on circulating inflammatory cytokines IFN-γ [Срок оценки: Change over 28 days comparison between treatments]
- Assess effect of FX856 on circulating inflammatory cytokines IL-1β [Срок оценки: Change over 28 days comparison between treatments]
- Assess effect of FX856 on circulating inflammatory cytokines IL-6 [Срок оценки: Change over 28 days comparison between treatments]
- Assess effect of FX856 on circulating inflammatory cytokines TNF-α [Срок оценки: Change over 28 days comparison between treatments]
- Assess effect of FX856 on Cholesterol [Срок оценки: Change over 28 days comparison between treatments]
- Assess effect of FX856 on LDL cholesterol [Срок оценки: Change over 28 days comparison between treatments]
- Assess effect of FX856 on HDL cholesterol [Срок оценки: Change over 28 days comparison between treatments]
- Assess effects of FX856 on microbiota [Срок оценки: Change over 28 days comparison between treatments]
- Assess effects of FX856 on faecal metabolome [Срок оценки: Change over 28 days comparison between treatments]
- Assess effects of FX856 on blood metabolome [Срок оценки: Change over 28 days comparison between treatments]
Критерии участия
Критерии включения
- Either a BMI 25+ kg/m2 and be aged 40+ years or have a BMI 30+ kg/m2 and aged 18+ years
- Males and females (not currently pregnant/lactating)
- Omnivorous diet (consuming plant \& animal based foods)
- Not taking any medication affecting the gastro-intestinal tract
- No chronic gastro-intestinal illness
- Not using fibre supplements or any probiotic or prebiotic products, e.g., Fybogel, Actimel, kefir or kimchee for at least 6 weeks prior to study
- Not consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine \~12%)
Критерии исключения
- Not aged 40+ years (if have a BMI 25-29.9 kg/m2)
- BMI<30 kg/m2 (if aged 18-39 years)
- Pregnant/lactating female
- Vegan/vegetarian/high protein diet
- Chronic gastro-intestinal illness
- Taking medication affecting the gastro-intestinal tract
- Taking fibre supplements or any probiotic or prebiotic products
- Consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine \~12%)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Великобритания · 1 центр
- Ulster University, Human Intervention Studies Unit — Coleraine
Идентификаторы
NCT: NCT07253155 · REC/25/0042