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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
No Placebo-Only Group
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Gut microbiome
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,125 Total Patients Enrolled
Manpreet S Mundi, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
42 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to receive nutrition through a feeding tube for at least 4-6 weeks from the start of the study.If you consume more than 25% of your daily calories through eating by mouth.You cannot participate if you have a condition called short bowel syndrome.You cannot participate if you are allergic or intolerant to the study products.You cannot participate in the study if you are receiving nutrition through an IV.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Polymeric Tube Feeds
- Group 2: Blenderized Tube Feeds
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