Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03795870
Other study ID # 18-004416
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 7, 2018
Est. completion date December 2024

Study information

Verified date April 2024
Source Mayo Clinic
Contact Manpreet S Mundi, MD
Phone 507-284-0106
Email Mundi.Manpreet@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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; InBodyâ„¢). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. All subjects who are above 18 years of age, who present to Mayo Clinic HEN program for initial evaluation prior to enteral tube placement 2. Require enteral nutrition support for at least 4-6 weeks from enrollment Exclusion Criteria: 1. Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing changes in the gut microbiome in this population. 2. Patients who have had exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks will be excluded. 3. Known allergy or intolerance to study products will be excluded. 4. Patients on parenteral nutrition will be excluded. 5. If oral feeding accounts for >25% of daily caloric intake. 6. Presence of entero-cutaneous fistula 7. Patients with short bowel syndrome will be excluded. 8. Patients who have had bariatric surgery or other alteration of GI tract will be excluded. 9. Hematologic malignancy with absolute neutrophil count < 500/mm3 10. History of renal or liver transplant or on transplant list.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Polymeric Tube Feeds
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 Feeds
Blenderized tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with polymeric tube feeds

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of goal calories provided 4-6 weeks
Secondary Gut microbiome A stool specimen will be collected to assess the composition of the gut microbiome at baseline and at the follow-up visit. 1 week, 4-6 weeks
See also
  Status Clinical Trial Phase
Completed NCT05473546 - Diarrhea and Stipsis in Critically Ill Patients (NUTRITI)
Active, not recruiting NCT05525585 - Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants N/A
Completed NCT04156529 - The Effect of Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants N/A
Completed NCT04119089 - Gastric Ultrasound to Monitor Gastric Residual Volume
Active, not recruiting NCT04337710 - Exclusive Enteral Nutrition in Preterm Neonates N/A
Completed NCT04804631 - Tube Feeding in Children Having a Bone Marrow Transplant
Recruiting NCT06076460 - Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation N/A
Completed NCT03497091 - Retrospective Review of Amino Acid Formula Use at a Children's Center
Recruiting NCT04551846 - The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care N/A
Completed NCT04946045 - Feeding Readiness and Oral Feeding Success in Preterm Infants N/A
Recruiting NCT04013893 - Evaluation of Enteral Nutrition in Critically Ill Children
Completed NCT03643458 - Splanchnic Oxygenation Response to Feeds in Preterm Neonates: Effect of Red Blood Cell Transfusion
Completed NCT03048409 - Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-Based Formula
Completed NCT03085277 - Bovine Colostrum for Preterm Newborns N/A
Completed NCT04241146 - Optimal Feeding Tube Placement N/A
Completed NCT01953081 - A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance Phase 1/Phase 2
Completed NCT03548324 - Enteral Nutrition Tolerance And REspiratory Support (ENTARES) N/A
Completed NCT04413474 - Ultrasonographic Assessment of Gastric Residual Volume
Recruiting NCT05265143 - Comparision of Two Different Feeding Method in Preterms N/A
Not yet recruiting NCT05812664 - The Effects of Bolus, Intermittent and Continuous Enteral Feeding on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis N/A