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临床试验/NCT07253155
NCT07253155Enrolling By Invitation不适用

Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity.

University of Ulster2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月14日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
2
主要终点
Assess effects of FX856 on faecal calprotectin

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double blinded to participants and researchers

入排标准

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

入选标准

  • 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%)

排除标准

  • 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%)

结局指标

主要结局

Assess effects of FX856 on faecal calprotectin

时间窗: Change over 28 days comparison between treatments

The level of calprotectin in faecal samples will be measured by immunoassay in all participants to determine if FX856 consumption can decrease it.

次要结局

  • Assess effect of FX856 treatment on gastrointestinal symptoms(Change over 28 days comparison between treatments)
  • Assess effect of FX856 on circulating inflammatory cytokines TNF-α(Change over 28 days comparison between treatments)
  • Assess effect of FX856 on Cholesterol(Change over 28 days comparison between treatments)
  • Assess effect of FX856 on LDL cholesterol(Change over 28 days comparison between treatments)
  • Assess effects of FX856 on microbiota(Change over 28 days comparison between treatments)
  • Assess effects of FX856 on faecal metabolome(Change over 28 days comparison between treatments)
  • Assess effect of FX856 on circulating inflammatory cytokines IFN-γ(Change over 28 days comparison between treatments)
  • Assess effect of FX856 on circulating inflammatory cytokines IL-1β(Change over 28 days comparison between treatments)
  • Assess effect of FX856 on circulating inflammatory cytokines IL-6(Change over 28 days comparison between treatments)
  • Assess effect of FX856 on HDL cholesterol(Change over 28 days comparison between treatments)
  • Assess effects of FX856 on blood metabolome(Change over 28 days comparison between treatments)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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