Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03795870 |
Other study ID # |
18-004416 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 7, 2018 |
Est. completion date |
December 2024 |
Study information
Verified date |
April 2024 |
Source |
Mayo Clinic |
Contact |
Manpreet S Mundi, MD |
Phone |
507-284-0106 |
Email |
Mundi.Manpreet[@]mayo.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
At the pre-enteral tube visit, subjects will complete a gastrointestinal quality of life
(QoL) questionnaire which will form the baseline assessment for symptoms and functional
status. Body composition will be measured using Bio-impedance analysis (BIA; InBodyâ„¢). A
stool specimen will be obtained for analysis of the gut microbiome at baseline. Baseline
clinical data such as current medical problems will be recorded.