To study the effect of oral/enteral fructose on enterocyte function and on the the gut microbiome and intestinal absorption capacity in patients with short bowel syndrome who are dependent on parenteral nutrition (PN) and/or intravenous (iv) fluids…
ID
Source
Brief title
Condition
- Malabsorption conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
primary outcome is the citrulline generation test (CGT) which reflects
Intestinal Enterocyte Function.
Secondary outcome
Secondary outcomes are microbiome composition and need for PN and iv fluids and
intestinal absorption capacity of nutrients and fluid.
Background summary
In mice, daily oral fructose intake improved intestinal enterocyte function
(IEF) by increased survival of intestinal enterocytes, increased intestinal
surface area and intestinal absorptive capacity (IAC). These effects might be
beneficial in patients with reduced intestinal absorption such as in patients
with short bowel syndrome and Intestinal Failure (IF).
Study objective
To study the effect of oral/enteral fructose on enterocyte function and on the
the gut microbiome and intestinal absorption capacity in patients with short
bowel syndrome who are dependent on parenteral nutrition (PN) and/or
intravenous (iv) fluids.
Study design
single blind, cross-over intervention study.
Intervention
daily oral/enteral fructose versus glucose for 4 weeks. Treatment periods will
be separated by a 4 week washout period. The dose of fructose will be
determined in a feasibility study in which we investigate gastro-intestinal
tolerance of different doses of oral fructose.
Study burden and risks
patients might experience gastrointestinal complaints to either glucose and/or
fructose. These might include increased stoma output/diarrhea or abdominal
cramps. Since fructose and glucose are nutrients that are consumed in regular
diets, no other side effects are expected. The citrulline generation test has
been well tolerated in an earlier study in a similar population and therefore
we do not expect side effects. Blood samples will be drawn from a peripheral iv
line which might induce mild discomfort. Four visits will be planned to perform
all study procedures.
If fructose increases absorptive capacity in patients dependent on PN, this
will impact the included particpants directly since treatment with fructose
will then be continued after study end. Eligible patients that did not
participate in the study will also be offered fructose treatment in case of
positive results.
Meibergdreef 9
Amsterdam 1105ZA
NL
Meibergdreef 9
Amsterdam 1105ZA
NL
Listed location countries
Age
Inclusion criteria
• Treated by the TPN and IF Clinic at Amsterdam UMC
• Ability to provide written informed consent (in Dutch)
• Age of 18 years or older
• Dependent on PN or iv fluids
• Stable weight or stable amount of PN/iv fluids during the 3 months prior to
start of the study
• Adapted intestinal function,i.e. >=2 years after last small bowel resection
(if applicable)
• Duodenum and proximal jejunum in situ
• Short bowel syndrome (< 200 cm small bowel)
Exclusion criteria
• Unable to read and understand the patient information letter and/or study
procedures
• Unable to tolerate oral or enteral nutrition
• Ultrashort bowel (<20 cm small bowel)
• Diabetes Mellitus
• Active inflammatory bowel disease
• Systemic scleroderma involving the gut
• Radiation-enteritis
• Endocrine and exocrine pancreatic insufficiency
• Severe renal impairment (creatinine clearance < 25 ml/minute)
• Severe hepatic impairment (> 3 times upperlimit)
• Severe metabolic acidosis
• Severe gastrointestinal motility disorder
• Known fructose intolerance
• A high fructose-intake in regular oral and/or enteral diet (> 35 gram/day)
• Contraindication for use of oral alanin and/ or glutamine
• Contraindication for use of oral fructose
• Body weight < 40 kg (because of CGT)
If patiënts participated in the Feasibility study, they are not allowed to
participate in the Pilot study
Design
Recruitment
Medical products/devices used
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 | NL85772.018.24 |