跳至主要内容
临床试验/NCT03795870
NCT03795870已完成不适用

The Effect of Blenderized Tube Feeding on Enteral Nutrition Tolerance and the Gut Microbiome: A Pilot Study

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
10
试验地点
2
主要终点
Percentage of goal calories provided

研究概览

简要总结

The current study will enroll patients who are going to require enteral nutrition support for at least 4 weeks and randomize them to standard polymeric formulas or blenderized tube feeding. They will be asked to fill out a questionnaire about their tolerance of enteral feeds. They will also be asked to provide stool samples before enrollment and after 4-6 weeks.

The study is trying to assess whether the use of whole food in blenderized tube feeding will be better tolerated and also lead to greater diversity of microbiome.

详细描述

Malnutrition remains highly prevalent in both acute and chronic diseases, leading to longer hospital length of stay, greater risk of hospital readmission, and overall increase in morbidity and mortality. Over the last few decades, studies have continued to reveal significant clinical benefit from nutrition support, including reduction in complications and length of stay, maintenance of gastrointestinal integrity, and overall improvement in clinical outcomes and mortality. Despite high prevalence of Home Enteral Nutrition(HEN), patients continue to struggle with intolerance of tube feeds leading to chronic underfeeding and weight loss. Current guidelines recommend using standard polymeric formula or high-protein standard formula in the hospitalized patient requiring EN and also recommend against routine use of formulas designed to be immune-modulatory, elemental/semi-elemental, disease-specific (diabetes), and organ-specific (hepatic, renal, pulmonary).

Blenderized Tube Feeding(BTF) offers a number of advantages to standard polymeric formula including being able to modify the macro-nutrient and fiber content based on patient preference. BTF use has also been increasing significantly in the past few years.

The gut microbiome, or gut host environment, consists of approximately 10 thousand cells and has been the subject of much interest as it relates to gastrointestinal homeostasis. Our aim therefore is to (1) characterize the structure and dynamics of complex microbial communities using 16S rRNA- encoding gene sequences; (2) determine how they change with EN and; (3) how they may be correlated with tolerance of EN.

A total of fifty subjects who are willing to participate in current trial and who meet eligibility will be recruited from the Mayo Clinic HEN program. Suitable subjects will be identified when they present at the initial HEN visit prior to undergoing enteral tube placement.

Written informed consent will be obtained from all individuals who participate in the study. The principal investigator or member of study team meet with each participant, review the consent form in detail and confirm the subject's understanding of the study. The study team will answer all questions posed by the participants and when convinced that the subject verbally demonstrates understanding of the protocol, they will obtain a signed consent. Only designated staff members are authorized to obtain informed consent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The randomization list will be generated using http://www.randomization.com and the investigator team will be blinded at enrollment using supplement codes. A designated study coordinator will hold the randomization codes and the codes will be revealed to the investigators only after the statistical analysis is complete.

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

  • All subjects who are above 18 years of age, who present to Mayo Clinic HEN program for initial evaluation prior to enteral tube placement
  • Require enteral nutrition support for at least 4-6 weeks from enrollment

排除标准

  • Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing changes in the gut microbiome in this population.
  • Patients who have had exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks will be excluded.
  • Known allergy or intolerance to study products will be excluded.
  • Patients on parenteral nutrition will be excluded.
  • If oral feeding accounts for >25% of daily caloric intake.
  • Presence of entero-cutaneous fistula
  • Patients with short bowel syndrome will be excluded.
  • Patients who have had bariatric surgery or other alteration of GI tract will be excluded.
  • Hematologic malignancy with absolute neutrophil count < 500/mm3
  • History of renal or liver transplant or on transplant list.

结局指标

主要结局

Percentage of goal calories provided

时间窗: 4-6 weeks

次要结局

  • Gut microbiome(1 week, 4-6 weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manpreet S. Mundi

Principal Investigator

Mayo Clinic

研究点 (2)

Loading locations...

相似试验