The objective of this study is to evaluate the gastro-intestinal tolerance, nutritional intake, and acceptability of an adjusted composition of an enteral tube feed for adults in need of long term nutritional support.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
indicatie voor sondevoeding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastro-intestinal tolerance based on:
- stool pattern defined as: consistency and frequency (use of Bristol Stool
Form Scale)
- GI tolerance symptom questionnaire including symptoms as nausea, vomiting,
burping, constipation, diarrhea.
Secondary outcome
- Volume of tube feeding administration
- Product compliance
- Acceptability of the product
- Use of complementary feeding
- Anthropometrics
- Adverse events (frequency, type)
- Medication use
Background summary
The composition of Nutricia's current tube nutrition has recently been
adjusted. The study product has become dominant in plant proteins compared to
the current product, which is dominant in milk proteins. Before the new product
will be launched on the market, it is important to establish that there are no
concerns related to the GI tolerance of the product, that the product has no
influence on nutritional intake and that the product is accepted by the
patients and health care professionals.
The demand for plant (dominant) protein variants in medical food products is
increasing and in the future, the use of milk proteins in medical food can be
(partially) replaced by the use of plant proteins, resulting in a lower
environmental impact.
Study objective
The objective of this study is to evaluate the gastro-intestinal tolerance,
nutritional intake, and acceptability of an adjusted composition of an enteral
tube feed for adults in need of long term nutritional support.
Study design
The study is an open label, exploratory study that will take place at multiple
centers in multiple countries. Four products will be examined, all of which
have the same adjusted product composition: Nutrison Standard, Nutrison
Multifiber, Nutrison Energy, Nutrison Energy Multifiber. Each product will be
examined in a separate study arm, which is why we call it a single arm study.
Intervention
Subjects will use their own current practice tube feed for 1 week (baseline
period) and will switch to the intervention tube feed with an adjusted
composition with a comparable energy density and fiber content as their current
tube for 2 weeks (intervention period). In this way, there are 4 separate study
groups as four difference products will be evaluated (n=20 per product group)
Study burden and risks
The burden on the patient is minimal. Patients are asked to answer a number of
questions about the stool pattern and any gastrointestinal symptoms that may
occur (2 times 7 days). After use of the intervention tube feed, it is possible
that some stomach and intestinal related discomforts may occur, such as
belching, flatulence, nausea, diarrhea or constipation. No risks are expected
that may be related to the product or the study procedures.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84024.056.23 |
| Other | Registratie in CT.gov volgt |