In this small study we want to show that two sequential measurements of intestinal transit time by SITZMARK-method will provide strongly correlated results. In this way we hope to ascertain that regression to the mean did not play a role in the…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
intestinal transit time measured by SITZMARK-method
Secondary outcome
inflammatory parameters and gut microbiota composition
Background summary
In the FEBALIGO-trial (43964) we have shown that intestinal transit time is
transferrable by fecal microbiota transfer from a donor. However, some doubt
remains about the validity of our findings, as this may be explained by
'regression to the mean', because of the strong statistical correlation between
baseline intestinal transit time and effect direction (faster or slower) and
size after treatment. Futhermore it is not known whether intestinal transit
time is different in our study population (metabolic syndrome patients) versus
healthy controls.
Study objective
In this small study we want to show that two sequential measurements of
intestinal transit time by SITZMARK-method will provide strongly correlated
results. In this way we hope to ascertain that regression to the mean did not
play a role in the observed effects in our FEBALIGO-study population.
Futhermore we will assess whether intestinal transit time is different between
metabolic syndrome patients and healthy controls.
Study design
10 test subjects with metabolic syndrome and 10 healthy lean subjects will
undergo measurement of the intestinal transit time 2 times in a period of 2
weeks (without intervention). They will take a SITZMARK-capsule on 3
consecutive days and undergo an abdominal X-ray on the day before the first
capsule (only in week 2) and on the day after the 3rd to count the markers and
determine the intestinal transit time. The baseline X-ray is in week 2 is
necessary to rule out a carry-over effect (markers from week 0 that are still
in situ in week 2).
Study burden and risks
This study will cost 2 hrs. During/after the visits participants will take a
total of 6 capsules in 6 days, 2 blood samples, 2x3 fecal samples, 3 abdominal
X-rays and they will fill out a food diary for 7 days (2 times). There is the
risk of a bruise and radiation-dose associated risks. Study participants health
will not benefit.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Male obese subjects with metabolic syndrome (n<=10): 18 to 70 years-old; body mass index (BMI) 30kg/m2 or above with at least 3 out of 5 NCEP metabolic syndrome criteria (fasting plasma glucose * 5.6 mmol/l, triglycerides * 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol < 1.03 mmol/l, blood pressure * 130/85 mmHg). Patients should be able to give informed consent and be on a stable diet.;Healthy control subjects: 18-69 jr oud, BMI 18,5-25m²/kg. 0/5 NCEP criteria for metabolic syndrome.
Exclusion criteria
Cholecystectomy, use of medication including PPI and antibiotics past three months, (expected) change of diet, episode of diarrhea during study period. irritable bowel syndrome-like complaints.
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 | NL58461.018.16 |