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Enteral Nutrition Tolerance and the Gut Microbiome Study

NCT03795870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-27

No results posted yet for this study

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.

Conditions

  • Enteral Feeding Intolerance

Interventions

DIETARY_SUPPLEMENT

Polymeric Tube Feeds

Polymeric tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with blenderized tube feeds

DIETARY_SUPPLEMENT

Blenderized Tube Feeds

Blenderized tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with polymeric tube feeds

Sponsors & Collaborators

Principal Investigators

  • Manpreet S Mundi, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-07
Primary Completion
2025-04-24
Completion
2025-04-24

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03795870 on ClinicalTrials.gov