Evaluation of the Gastro-intestinal Tolerance of an Upgraded Composition of an Enteral Tube Feed for Adults

NCT ID: NCT05902806

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2024-02-05

Brief Summary

This study evaluates the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support.

Detailed Description

Four current tube feed products are upgraded with the same product composition and will be investigated in this study. Subjects will be asked to continue with their current tube feeding for 7 days (baseline period) and asked to complete a daily gastro-intestinal tolerance questionnaire. On Day 8, the subjects will switch to one of four upgraded tube feeding products for 14 days (intervention period). The subjects are asked to complete the same gastro-intestinal tolerance questionnaire for again 7 days. On Day 21 (end of intervention), the subjects will return to their original tube feed product and the investigator will follow up on how they are feeling to evaluate tolerability and product acceptability.

Conditions

Enteral Tube Nutrition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Comparison of current tube feed to intervention feed with upgraded composition

Subjects will use their own current practice tube feed for 1 week (baseline period) and will switch to the intervention tube feed with an upgraded composition with a comparable energy density and fiber content as their current tube for 2 weeks (intervention period). Since four different products will be evaluated (product A-D), there will be 4 study groups

Group Type: EXPERIMENTAL

Upgraded tube feed

Intervention Type: DIETARY_SUPPLEMENT

Total duration of study: 4 weeks; 1 week on current tube feed followed by 2 weeks on upgraded tube feed comparable in energy density and fiber content as their current tube feed. The tube feeding regimen is similar to pre study feeding regimen. There will then be a one week follow up period.

Interventions

Upgraded tube feed

Total duration of study: 4 weeks; 1 week on current tube feed followed by 2 weeks on upgraded tube feed comparable in energy density and fiber content as their current tube feed. The tube feeding regimen is similar to pre study feeding regimen. There will then be a one week follow up period.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Using either an enteral tube feed with approximately 1.0 or 1.5 kcal/mL with or without fibers via a nasogastric tube (NGT), nasojejunal (NJT) or Percutaneous Endoscopic Gastrostomy (PEG) for at least 4 weeks prior to screening

3. Actual and expected average daily intake of enteral nutrition at least 1000 kcal for at least 21 days after the start of baseline period

4. Written informed consent from subject (or impartial witness after verbal consent of subject)

Exclusion Criteria

1. Subjects receiving total parental feeding (TPN) 2. Gastro-intestinal surgery or any other surgery involving general anaesthesia within 2 weeks prior to screening 3. Subjects with major hepatic or renal dysfunction in the opinion of the Investigator 4. Subjects currently in the intensive care unit 5. Active/flare up condition of chronic illnesses in small or large intestines in the opinion of the Investigator (e.g., active inflammation/flare up of Crohn's disease or ulcerative colitis) within 2 weeks prior to screening, 6. Subjects experiencing cancer treatment-related diarrhea within 2 weeks prior to screening 7. Presence of colostomy or other faecal diversion 8. Known intolerance or allergy to ingredients of study product (e.g. galactosemia, allergy to soy) 9. Inability of the subject to answer the study diary or questionnaires due to e.g., being unconscious, cognitive impairment, or dementia, in the opinion of the Investigator 10. Known pregnancy or lactation 11. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 12. Active participation in any other clinical study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study in the opinion of the Investigator

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

QClinical

Rotterdam, , Netherlands

Countries

Netherlands

Other Identifiers

SBB22R&56358

Identifier Type: -

Identifier Source: org_study_id