Status:
COMPLETED
Enteral Nutrition Tolerance and the Gut Microbiome Study
Lead Sponsor:
Mayo Clinic
Conditions:
Enteral Feeding Intolerance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed 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 mortali...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03795870
Start Date
July 7 2018
End Date
April 24 2025
Last Update
April 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905