Primary objective: to objectify the influence of Roux-en-y gastric bypass surgery on the prevalence of lactose intolerance / malabsorption.Secondary objective: To determine the usability of the lactose hydrogen breath test, the lactose tolerance…
ID
Source
Brief title
Condition
- Malabsorption conditions
- Bone, calcium, magnesium and phosphorus metabolism disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Prevalence and intensity of lactose intolerance and
malabsorption 1 year after Roux-en-y gastric bypass surgery.
Secondary outcome
Secondary outcome: Usability and inter-test variability of the lactose hydrogen
breath test, the lactose tolerance test and lactose intolerance questionnaire 1
year after Roux-en-Y gastric bypass.
Background summary
A common problem after Roux-en-y gastric bypass surgery is an insufficient
calcium intake and uptake. Frequently vitamin D deficiencies and elevated PTH
levels are found. This could eventually lead to osteoporosis. Sufficient intake
of dairy, which is the primary source of calcium in a Western diet, after RYGB
is desired.
Unfortunately, a proportion of patients experience gastro-intestinal complaints
after the consumption of dairy products after RYGB. Exact numbers are unknown.
It is of interest to determine the prevalence and pathophysiology of this
(secondary) lactose intolerance / malabsorption after RYGB.
Study objective
Primary objective: to objectify the influence of Roux-en-y gastric bypass
surgery on the prevalence of lactose intolerance / malabsorption.
Secondary objective: To determine the usability of the lactose hydrogen breath
test, the lactose tolerance test and a lactose intolerance questionnaire after
Roux-en-Y gastric bypass.
Study design
This is a case control study.
Using a questionnaire, the prevalence of the reported gastro-intestinal
complaints will be determined. Lactose malabsorption will be objectified/
determined using the lactose hydrogen breath test and lactose tolerance test. A
group of patients more than 1 year after RYGB and a non-surgery group of
patients with morbid obesity will be tested.
Study burden and risks
Completion of the questionnaire is not stressful and can be done in less than 5
minutes.
Patients with unexplained gastro-intestinal complaints can benefit of
participation in this study when positive test results indicate lactose
intolerance, dietary alterations can be made. There are no other benefits for
participants.
The lactose hydrogen breath test and lactose tolerance test are considered safe
tests and are usually well tolerated. The lactose tolerance test requires the
testing of capillary blood samples obtained via finger-prick.
Patients with lactose intolerance can experience complaints of nausea,
vomiting, bowel cramps, flatulence and diarrhea after intake of the
lactose/glucose drink required for testing.
Spaarnepoort 1
Hoofddorp 2134TM
NL
Spaarnepoort 1
Hoofddorp 2134TM
NL
Listed location countries
Age
Inclusion criteria
Patients more than 1 year after Roux-en-y gastric bypass surgery and patients
with morbid obesity who whether or not opt for Roux-en-y gastric bypass.
Exclusion criteria
- Diabetes mellitus
- Recent use of probiotics and/or antibiotics (<28 days)
- Gastro-intestinal disease/surgery other than RYGB surgery
- Consumpion of >60 gram (= 6 units) alcohol/day
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57680.048.16 |