Enteral Tube Nutrition
Conditions
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.
Interventions
DIETARY_SUPPLEMENTUpgraded 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.
Sponsors
Nutricia Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Single arm, open-label, multi-centre, multi-country, exploratory study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bowel movement pattern | 7 days in the 1-week baseline period | 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 |
| Gastro-intestinal tolerance | 7 days in the 1-week baseline period | self-reported GI symptoms with a GI symptom questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between prescribed volume of tube feed administration by Health Care Professional and actual daily self-reported administrated volume of tube feed | 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 compliance |
| Use of complementary feeding with a questionnaire ((use of normal foods, oral nutritional supplements, parenteral feeding: Yes/No) | 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). | Self reported complementary feeding |
| Anthropometrics | Baseline Day 1 | Body Height (cm) |
| Product acceptability with a questionnaire | Day 7 end of baseline period regarding the current tube feed | Self reported product acceptability |
| Volume of tube feed administration | 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). | Self reported volume of feed administered |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication | 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 | Self reported use of predefined relevant medication with questionnaire (e.g. GI related medication like use of laxatives, antidiarrheals) |
Countries
Netherlands
Outcome results
None listed