Enteral Feeding IntoleranceNCT03795870
Enteral Nutrition Tolerance and the Gut Microbiome Study
A study testing Polymeric Tube Feeds and Blenderized Tube Feeds in people with Enteral Feeding Intolerance, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- Polymeric Tube Feeds and Blenderized Tube Feeds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2018to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effect of Blenderized Tube Feeding on Enteral Nutrition Tolerance and the Gut Microbiome: A Pilot Study
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.
Read the detailed description
Malnutrition remains highly prevalent in both acute and chronic diseases, leading to longer hospital length of stay, greater risk of hospital readmission, and overall increase in morbidity and mortality. Over the last few decades, studies have continued to reveal significant clinical benefit from nutrition support, including reduction in complications and length of stay, maintenance of gastrointestinal integrity, and overall improvement in clinical outcomes and mortality. Despite high prevalence of Home Enteral Nutrition(HEN), patients continue to struggle with intolerance of tube feeds leading to chronic underfeeding and weight loss. Current guidelines recommend using standard polymeric formula or high-protein standard formula in the hospitalized patient requiring EN and also recommend against routine use of formulas designed to be immune-modulatory, elemental/semi-elemental, disease-specific (diabetes), and organ-specific (hepatic, renal, pulmonary).
Blenderized Tube Feeding(BTF) offers a number of advantages to standard polymeric formula including being able to modify the macro-nutrient and fiber content based on patient preference. BTF use has also been increasing significantly in the past few years.
The gut microbiome, or gut host environment, consists of approximately 10 thousand cells and has been the subject of much interest as it relates to gastrointestinal homeostasis. Our aim therefore is to (1) characterize the structure and dynamics of complex microbial communities using 16S rRNA- encoding gene sequences; (2) determine how they change with EN and; (3) how they may be correlated with tolerance of EN.
A total of fifty subjects who are willing to participate in current trial and who meet eligibility will be recruited from the Mayo Clinic HEN program. Suitable subjects will be identified when they present at the initial HEN visit prior to undergoing enteral tube placement.
Written informed consent will be obtained from all individuals who participate in the study. The principal investigator or member of study team meet with each participant, review the consent form in detail and confirm the subject's understanding of the study. The study team will answer all questions posed by the participants and when convinced that the subject verbally demonstrates understanding of the protocol, they will obtain a signed consent. Only designated staff members are authorized to obtain informed consent.
At the pre-enteral tube visit, subjects will complete a gastrointestinal quality of life (QoL) questionnaire which will form the baseline assessment for symptoms and functional status. Body composition will be measured using Bio-impedance analysis (BIA; InBody™). A stool specimen will be obtained for analysis of the gut microbiome at baseline. Baseline clinical data such as current medical problems will be recorded.
- Conditions
- Enteral Feeding Intolerance
- Being tested
- Polymeric Tube Feeds, Blenderized Tube Feeds
- Keywords
- Home Enteral Nutrition, Gut Microbiome, Blenderized Tube Feeds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymeric Tube FeedsDietary supplement
Polymeric tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with blenderized tube feeds
Blenderized Tube FeedsDietary supplement
Blenderized tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with polymeric tube feeds
| Study group | Role | What they receive |
|---|---|---|
| Polymeric Tube Feeds | Active comparator | This arm will be receiving Polymeric Tube Feeds as a part of the regular HEN Protocol. Receives: 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. Receives: Dietary Supplement: Blenderized Tube Feeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of goal calories provided
Measured: 4-6 weeks
Secondary outcomes (1)
Gut microbiome
A stool specimen will be collected to assess the composition of the gut microbiome at baseline and at the follow-up visit.
Measured: 1 week, 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start7 Jul 2018
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Feeding IntoleranceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manpreet S. Mundi, Mayo Clinic
- Investigators
- Manpreet S Mundi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795870
- Sponsor's protocol ID
- 18-004416
- Status last verified
- Apr 2025
- First submitted
- 10 Dec 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blenderized Tube Feeding on Enteral Nutrition Tolerance and the Gut Microbiome: A Pilot Study
- ClinicalTrials.gov ID
- NCT03795870
- Acronym / sponsor ID
- 18-004416
- Conditions
- Enteral Feeding Intolerance
- Keywords
- Home Enteral Nutrition, Gut Microbiome, Blenderized Tube Feeds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Jul 2018 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Malnutrition remains highly prevalent in both acute and chronic diseases, leading to longer hospital length of stay, greater risk of hospital readmission, and overall increase in morbidity and mortality. Over the last few decades, studies have continued to reveal significant clinical benefit from nutrition support, including reduction in complications and length of stay, maintenance of gastrointestinal integrity, and overall improvement in clinical outcomes and mortality. Despite high prevalence of Home Enteral Nutrition(HEN), patients continue to struggle with intolerance of tube feeds leading to chronic underfeeding and weight loss. Current guidelines recommend using standard polymeric formula or high-protein standard formula in the hospitalized patient requiring EN and also recommend against routine use of formulas designed to be immune-modulatory, elemental/semi-elemental, disease-specific (diabetes), and organ-specific (hepatic, renal, pulmonary).
Blenderized Tube Feeding(BTF) offers a number of advantages to standard polymeric formula including being able to modify the macro-nutrient and fiber content based on patient preference. BTF use has also been increasing significantly in the past few years.
The gut microbiome, or gut host environment, consists of approximately 10 thousand cells and has been the subject of much interest as it relates to gastrointestinal homeostasis. Our aim therefore is to (1) characterize the structure and dynamics of complex microbial communities using 16S rRNA- encoding gene sequences; (2) determine how they change with EN and; (3) how they may be correlated with tolerance of EN.
A total of fifty subjects who are willing to participate in current trial and who meet eligibility will be recruited from the Mayo Clinic HEN program. Suitable subjects will be identified when they present at the initial HEN visit prior to undergoing enteral tube placement.
Written informed consent will be obtained from all individuals who participate in the study. The principal investigator or member of study team meet with each participant, review the consent form in detail and confirm the subject's understanding of the study. The study team will answer all questions posed by the participants and when convinced that the subject verbally demonstrates understanding of the protocol, they will obtain a signed consent. Only designated staff members are authorized to obtain informed consent.
At the pre-enteral tube visit, subjects will complete a gastrointestinal quality of life (QoL) questionnaire which will form the baseline assessment for symptoms and functional status. Body composition will be measured using Bio-impedance analysis (BIA; InBody™). A stool specimen will be obtained for analysis of the gut microbiome at baseline. Baseline clinical data such as current medical problems will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled
| Arm | Type | Receives |
|---|---|---|
| Polymeric Tube Feeds | Active comparator | Dietary Supplement: Polymeric Tube FeedsThis arm will be receiving Polymeric Tube Feeds as a part of the regular HEN Protocol. |
| Blenderized Tube Feeds | Active comparator | Dietary Supplement: Blenderized Tube FeedsThis arm will be receiving Blenderized tube feeds as a part of the regular HEN Protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymeric Tube FeedsPolymeric tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with blenderized tube feeds | Dietary supplement | Polymeric Tube Feeds |
| Blenderized Tube FeedsBlenderized tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with polymeric tube feeds | Dietary supplement | Blenderized Tube Feeds |
Primary outcome
Percentage of goal calories provided
Time frame: 4-6 weeks
1 secondary outcome
Gut microbiome
Time frame: 1 week, 4-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Enteral Feeding Intolerance
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Recruiting
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Enteral Feeding Intolerance
Recruiting
Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
Enteral Feeding Intolerance, Critical Illness
Not yet recruitingObservational study
Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
Refractory Enteral Feeding Intolerance, Gut Microbiota
Not yet recruiting
Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance
Enteral Feeding Intolerance, ICU
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manpreet S Mundi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymeric Tube Feeds and Blenderized Tube Feeds in people with Enteral Feeding Intolerance, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of goal calories provided (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.