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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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 added 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Gastro-intestinal tolerance based on:<br /><br>- stool pattern defined as: consistency and frequency (use of Bristol Stool<br /><br>Form Scale)<br /><br>- GI tolerance symptom questionnaire including symptoms as nausea, vomiting,<br /><br>burping, constipation, diarrhea. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Volume of tube feeding administration<br /><br>- Product compliance<br /><br>- Acceptability of the product<br /><br>- Use of complementary feeding<br /><br>- Anthropometrics<br /><br>- Adverse events (frequency, type)<br /><br>- Medication use</p><br>