The Effect of Blenderized Tube Feeding on Enteral Nutrition Tolerance and the Gut Microbiome
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-004416
NCT ID: NCT03795870
Sponsor Protocol Number: 18-004416
About this study
The purpose of this study is to examine the differences in percent of goal calories provided through blenderized tube feeding (BTF) and standard enteral formula, as well as to examine the impact in the gut microbiome in patients receiving BTF compared to standard formula.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- All subjects who are managed by the Mayo Clinic HEN program for enteral nutrition.
- Require EN support for at least 4-6 weeks from enrollment.
Exclusion Criteria:
- Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing changes in the gut microbiome in this population.
- All patients will not have had exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks.
- Known allergy or intolerance to study products.
- On parenteral nutrition.
- Oral feeding accounts for > 25% of calories.
- Presence of entero-cutaneous fistula.
- Short bowel syndrome.
- Bariatric surgery or other alteration of GI tract.
- Hematologic malignancy with absolute neutrophil count < 500/mm^3.
- History of renal or liver transplant or on transplant list.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Manpreet Mundi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available