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临床试验/NCT06745245
NCT06745245进行中(未招募)不适用

Effect of Oral Consumption of a Symbiotic Gelatin on the Presence of Gastrointestinal Symptoms and Quality of Life in People With Chronic Kidney Disease Grades G3a, G3b, G4, G5 and G5D in Mexico

NIN Institute2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
32
试验地点
2
主要终点
Gastrointestinal symptoms

研究概览

简要总结

In patients with chronic kidney disease (CKD) there is a high prevalence of gastrointestinal disorders and negative changes in the microbiota and assimilation of nutrients, which is associated with an increased risk of morbidity and mortality.

详细描述

Gastrointestinal changes in CKD. In addition to the intrinsic effect of CKD on the gastrointestinal tract, extrinsic factors such as;Changes in diet (reduction in fiber consumption and increase in ultra-processed products), decrease in physical activity which impacts the reduction of gastrointestinal motility and the consumption of medications constantly can affect the structure and function at the gastrointestinal level. In HD patients without diabetes mellitus, the prevalence of dyspepsia is 40% to 70%. It is hypothesized that the pathophysiology of functional dyspepsia is multifactorial and may include a number of factors such as; abnormal gastric motility, impaired visceral sensation, dysregulation of the gut-brain axis, and low-grade inflammation.

Clinical evidence supports the theory that gut with dysbiosis contributes significantly to the deterioration of CKD progression, leading to an increase in bowel-derived uremic toxins (GDUT) and worsening of the same disease. Strategies based on interventions in the gut microbiota could contribute as preventive and therapeutic approaches to modulate the microbiota and its metabolites and thereby slow down the progression of CKD.

The origin of uremic toxins in CKD is multiple. The importance of the toxin generated by intestinal microbial metabolism is becoming more and more known. About 10 g of protein reaches the colon daily, where gut bacteria break it down into metabolites such as ammonium, amines, thiols, phenols, and indoles. These products of fermentation in the colon are eliminated in the feces, although some are absorbed and eliminated by the kidney, so they accumulate in CKD.

On the other hand, patients with CKD are constantly polymedicated. Some drugs frequently prescribed to these patients can alter the gut microbiota, especially antibiotics. There are also others that can slow down intestinal transit, phosphorus binders, ion exchange resins, or iron supplements, whose impact on the microbiota is not yet well known.

This project will provide practical information for the validation of the therapeutic effect of a symbiotic gelatin on gastrointestinal symptoms and quality of life in patients with CKD with and without replacement therapy, which will be useful both for health professionals and for the patients themselves.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous hospitalizations in the last month.
  • Diagnosis of comorbidities such as cancer, decompensated heart failure, decompensated lung disease, decompensated liver disease, HIV, infection present within the last 3 months (chronic and/or acute) stroke, malabsorption syndrome or allergy to any ingredient of the nutritional supplement.
  • Colon surgeries in the past 6 months (obstruction, resection of a portion).
  • Presence of ostomies.
  • Who show current treatment of antibiotics or oral iron.

排除标准

  • Failure to attend evaluation and biochemical tests at the beginning and end of the study.
  • Non-compliance with ≥ 10% of probiotics + fiber intakes (≥ 3 sachets in 15 days) during the intervention period.
  • Identification of serious adverse effects.
  • Withdrawal of voluntary participation by the patient.

结局指标

主要结局

Gastrointestinal symptoms

时间窗: baseline intervention and 1.5 months

Evaluate the presence and intesity of gastrointestinal symptoms for all patients from baseline to 1.5 month of intervention, through a Likert escale, with 5 being very intense and 1 being almost null.

Renal function

时间窗: Baseline intervention and one and a half months

Evaluate Glomerular Filtration Rate using the CKD-EPI creatinine equation in all patients at baseline and one and a half months

次要结局

  • Adherence to oral supplement(At 1.5 months of intervention)
  • Adverse effects(At baseline and 1.5 months of intervention)

研究者

发起方
NIN Institute
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Ari Cisneros-Hernández

Principal Investigator

NIN Institute

研究点 (2)

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