CompletedNot Applicable

Enteral Nutrition Tolerance and the Gut Microbiome Study

United States10 participantsStarted 2018-07-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 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.
✕. 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.

What they're measuring

Percentage of goal calories provided

Timeframe: 4-6 weeks

Trial details

NCT IDNCT03795870

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-24

View on ClinicalTrials.gov More Enteral Feeding Intolerance trials