Enteral Nutrition Tolerance and the Gut Microbiome Study

NCT03795870 | Completed DMC

• 1 other identifier: 18-004416
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Keywords

Home Enteral Nutrition; Gut Microbiome; Blenderized Tube Feeds

Outcome Measures

Primary Outcomes (1)

• Percentage of goal calories provided

  4-6 weeks

Secondary Outcomes (1)

• Gut microbiome

  1 week, 4-6 weeks

Study Arms (2)

Polymeric Tube Feeds

ACTIVE COMPARATOR

This arm will be receiving Polymeric Tube Feeds as a part of the regular HEN Protocol.

Dietary Supplement: Polymeric Tube Feeds

Blenderized Tube Feeds

ACTIVE COMPARATOR

This arm will be receiving Blenderized tube feeds as a part of the regular HEN Protocol.

Dietary Supplement: Blenderized Tube Feeds

Interventions

Polymeric Tube Feeds DIETARY_SUPPLEMENT

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

Polymeric Tube Feeds

Blenderized Tube Feeds DIETARY_SUPPLEMENT

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

Blenderized Tube Feeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Manpreet S Mundi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The randomization list will be generated using http://www.randomization.com and the investigator team will be blinded at enrollment using supplement codes. A designated study coordinator will hold the randomization codes and the codes will be revealed to the investigators only after the statistical analysis is complete.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective Randomized Controlled

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: January 8, 2019
• Study Start: July 7, 2018
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)