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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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