← Back to Search

Dietary Supplement

Tube Feeds for Enteral Feeding Intolerance

N/A

Recruiting

Led By Manpreet S Mundi, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week, 4-6 weeks

Awards & highlights

Study Summary

This trial will enroll patients who require long-term enteral nutrition support, and will compare the use of standard polymeric formulas versus blenderized whole foods. Tolerance will be assessed via questionnaire, and microbiome diversity will be measured via stool samples.

Who is the study for?

This trial is for adults needing tube feeding for at least 4-6 weeks and not eating much by mouth. It's not for those who've had recent probiotics, antibiotics, GI surgery, or certain diseases like diabetes or cancer with low white blood cells. People with allergies to the feeds used in the study can't join either.Check my eligibility

What is being tested?

The study compares two types of tube feeding: blenderized whole foods versus standard formula. Participants will answer questions about how well they tolerate their feeds and provide stool samples to see if one type leads to a healthier gut microbiome.See study design

What are the potential side effects?

Possible side effects may include digestive discomfort such as bloating, gas, constipation or diarrhea due to different food compositions in the tube feeds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week, 4-6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week, 4-6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 4-6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of goal calories provided

Secondary outcome measures

Gut microbiome

Trial Design

2Treatment groups

Active Control

Group I: Polymeric Tube FeedsActive Control1 Intervention

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

Group II: Blenderized Tube FeedsActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,233 Previous Clinical Trials

3,771,776 Total Patients Enrolled

Manpreet S Mundi, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

42 Total Patients Enrolled

Media Library

Blenderized Tube Feeds (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03795870 — N/A

Enteral Feeding Intolerance Clinical Trial 2023: Blenderized Tube Feeds Highlights & Side Effects. Trial Name: NCT03795870 — N/A

Blenderized Tube Feeds (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03795870 — N/A

Enteral Feeding Intolerance Research Study Groups: Polymeric Tube Feeds, Blenderized Tube Feeds

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of recruitment for this trial?

"Affirmative. According to information found on the clinicaltrials.gov website, this trial is currently recruiting new participants; it was first posted in November 2019 and last updated in April 2022. The research team hopes to enrol 50 patients from one site alone."

Answered by AI

Is this research initiative currently seeking participants?

"Data hosted on clinicaltrials.gov suggests that this trial is still open to participants; it was posted in November 2019 and the information has been recently refreshed as of April 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enteral Nutrition Tolerance and the Gut Microbiome Study

Manpreet S. Mundi 2018. "Enteral Nutrition Tolerance and the Gut Microbiome Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03795870.

All > Microbiome