跳至主要内容
临床试验/NCT01831323
NCT01831323Unknown不适用

Evaluation of the Metabolome in Diverticular Disease and Effects of Probiotic Mixture VSL#3 vs Fibers, Rifaximin and Mesalazine on the Metabolome in Diverticular Disease of the Colon

S.Eugenio Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
identify the metabolome of symptomatic uncomplicated Diverticular Disease (SUDD)

研究概览

简要总结

To evaluate the effect of the probiotic formulation VSL#3 on the metabolome and microbiota of diverticular disease, comparing it with the effects exerted by supplementation with fibers, by rifaximin and by mesalazine, and assessing the evolution over time after each specific treatment

详细描述

The incidence of diverticular disease of the colon has increased over the last few years. Since it presents potentially severe complications (both in terms of morbidity and mortality), the most recent studies are focusing on the underlying mechanisms and therapeutic options.

Diverticular disease of the colon presents important etiopathogenetic events. The first is that the severity of microscopic inflammation is correlated to the disease activity. The second is the bacterial overgrowth which is observed in the colon, where the diverticula form "recesses" where bacteria can proliferate. The third is that the "metabolome" plays an important role in the pathogenesis of diseases of the gastrointestinal tract (and not only). An extensive combination of microbial species live permanently in the human gut and participate in the metabolic activities of the gastro-intestinal tract (such as the synthesis of certain vitamins, improvement of the immune system, and balance of the resident bacterial species). There is little published clinical evidence suggesting a direct link between microbiota and diverticular disease; however, an altered microbiota in the flora of patients with colon cancer, irritable bowel syndrome, and IBD has been described.

It is clear that human metabolism and inflammatory response are influenced by genetic information outside our genome. Insights into the influence of microorganisms on the pathogenesis in gastrointestinal function and diverticular disease are in their infancy and often rely on extrapolation from other disease states. Microbiological analysis of fecal microbiota can provide important information on the role that the microbial-mammalian axis might have on the pathogenesis of diverticular disease.

Alteration of the metabolome play an important role in some pathologies of the gastrointestinal tract, from Inflammatory Bowel Diseases (IBD) to Irritable Bowel Syndrome (IBS). Most likely, it plays the same role in diverticular disease. In fact, the current western diet is poor in fibers and can cause an alteration of the resident bacterial species, with a reduction of bifidobacteria and an increase of clostridia.

This alteration might be present in diverticular disease and the manipulation of the microbial flora might represent both a treatment option for diverticular disease and the prevention of its complications.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

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

入选标准

  • Female patients over 18 years of age
  • Patient with a diagnosis of uncomplicated symptomatic diverticular disease diagnosed for the first time
  • Patient able to comply with the procedures of the Protocol
  • Ability to sign written informed consent

排除标准

  • Segmental colitis associated with diverticulosis
  • Inflammatory Bowel Disease
  • Active or recent peptic ulceration
  • Chronic renal failure
  • Known allergy to products in the study
  • Use of lactulose-lactitol in the two weeks prior to enrollment and during the study
  • Previous surgery of the colon
  • Diverticular disease-related complications (fistulas, abscesses, stenosis)
  • Use of probiotics in the 4 weeks prior to enrolment
  • Renal, hepatic, hematologic, cardiovascular, pulmonary, neurological, psychiatric, immunological, gastrointestinal or endocrine disease, if found to be clinically significant
  • Active malignancy or history of any type of malignancy.
  • Recent history or suspicion of abuse of alcohol or drugs
  • Women who are pregnant, nursing or of childbearing age not using appropriate contraceptive methods
  • Any severe pathology that may interfere with the treatment
  • Inability to provide written informed consent
  • Not sufficiently reliable or presence of conditions that can result in non-compliance / patient adherence to the Protocol
  • Previous participation in another study
  • Lack of compliance towards the products in the study

研究组 & 干预措施

mesalazine

10 female patients with first diagnosis of SUDD will take mesalazine 1,6g per day for 14 days (1 tablet 800mg twice daily)

干预措施: Mesalazine (Drug)

VSL#3

10 female patients with first diagnosis of SUDD will take VSL#3 2 sachets a day for 14 days (1 sachet twice a day, for a total of 900 billion bacteria per day)

干预措施: VSL#3 (Dietary Supplement)

Rifaximin

10 female patients with first diagnosis of SUDD will take 800mg/day of rifaximin (2 tablets of 200mg twice a day)

干预措施: Rifaximin (Drug)

fiber

10 female patients with first diagnosis of SUDD will take fibers for 14 days (psyllium 10grams per day)

干预措施: Psyllium (Dietary Supplement)

结局指标

主要结局

identify the metabolome of symptomatic uncomplicated Diverticular Disease (SUDD)

时间窗: 12 months

As no studies have ever been conducted or published on this aspect, the main outcome of the study is to analyze and identify the metabolome of patients with SUDD before starting any therapy and after a 2 week therapy of a probiotic, fibers or antibiotics. The metabolomic analysis will allow a precise evaluation of the systemic and organ-specific processes based on low molecular weight components thus providing a profile of the metabolic system of these patients.

verify changes in the intestinal microbiota following treatment in the different study groups.

时间窗: 12 months

次要结局

  • evaluate if difference in the symptomatology in the different groups are correlated with changes in the intestinal microbiota(12 months)
  • evaluate the symptomatology and metabolome(12 months)
  • evaluate the different metabolomes and microbiota according to the treatment used(12 months)
  • Evaluate the effects of supplementation with VSL#3 on the metabolome and microbiota of Diverticular Disease(12 months)

研究者

发起方
S.Eugenio Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gian Marco Giorgetti

Dott. in Medicina Interna, Chirurgia oncologica, immunologia e allergologia

S.Eugenio Hospital

研究点 (1)

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