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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of 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 (Peacock Butterfly)

Conditions
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Enteral Tube Nutrition

Intervention / Treatment
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* Dietary Supplement: Upgraded tube feed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years 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 Actual and expected average daily intake of enteral nutrition at least 1000 kcal for at least 21 days after the start of baseline period 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, open-label, multi-centre, multi-country, exploratory study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comparison of current tube feed to intervention feed with upgraded composition<br>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 | Dietary Supplement: Upgraded tube feed<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro-intestinal tolerance | self-reported GI symptoms with a GI symptom questionnaire | 7 days in the 1-week baseline period | 
| Gastro-intestinal tolerance | self-reported GI symptoms with a GI symptom questionnaire | 7 days in the second week of the 2-week intervention period | 
| bowel movement pattern | Self reported bowel movement pattern with the 7-point Bristol Stool Form Scale (BSFS) ranging from 1 (indicating separate, hard lumps) to 7, which stands for entirely liquid, watery stool without any hard components | 7 days in the 1-week baseline period | 
| bowel movement pattern | Self reported bowel movement pattern with the 7-point Bristol Stool Form Scale (BSFS) ranging from 1 (indicating separate, hard lumps) to 7, which stands for entirely liquid, watery stool without any hard components | 7 days in the second week of the 2-week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of tube feed administration | Self reported volume of feed administered | 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration). | 
| Difference between prescribed volume of tube feed administration by Health Care Professional and actual daily self-reported administrated volume of tube feed | Product compliance | 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration). | 
| Use of complementary feeding with a questionnaire ((use of normal foods, oral nutritional supplements, parenteral feeding: Yes/No) | Self reported complementary feeding | 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration). | 
| Product acceptability with a questionnaire | Self reported product acceptability | Day 7 end of baseline period regarding the current tube feed | 
| Product acceptability with a questionnaire | Self reported product acceptability | Day 21 (end of intervention period regarding the upgraded tube feed) | 
| Anthropometrics | Body Height (cm) | Baseline Day 1 | 
| Anthropometrics | Body weight (kg) | Baseline Day 1 | 
| Anthropometrics | Body weight (kg) | Baseline Day 7 | 
| Anthropometrics | Body weight (kg) | Intervention Day 7 | 
| Anthropometrics | Body weight (kg) | Intervention Day 14 | 
| Anthropometrics | Body weight (kg) | Intervention Day 21 | 
| Anthropometrics | Body mass index (kg/m^2) | Baseline Day 1 | 
| Anthropometrics | Body mass index (kg/m^2) | Baseline Day 7 | 
| Anthropometrics | Body mass index (kg/m^2) | Intervention Day 7 | 
| Anthropometrics | Body mass index (kg/m^2) | Intervention Day 14 | 
| Anthropometrics | Body mass index (kg/m^2) | Intervention Day 21 |