To investigate the influence of left and right lateral position on the onset of TLESRs and GER and the underlying mechanisms during and after a test meal in GERD patients compared to healthy controls.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Time to first TLESR 2) Number of TLESRs in the first 15 minutes 3) Total
number of TLESRs 4) Cumulative 13C excretion at first TLESR 5) Gastric volume
(number of voxels) at first TLESR.
Secondary outcome
1) Total number of acid/ weakly acidic/ weakly alkaline GER episodes 2) Total
number of liquid/mixed/gas GER 3) Total gastric volume (number of voxels) 4)
Total gastric emptying time
Background summary
The movement of gastric contents into the esophagus, gastro-esophageal reflux
(GER) does not only occur in patients with GER disease (GERD) but is universal
in healthy volunteers as well. When GER leads to symptoms or complications it
is referred to as GERD. The underlying mechanism of GER is transient lower
esophageal sphincter relaxation (TLESR) in GERD patients and in healthy
volunteers. The number of GER episodes in healthy volunteers and GERD patients
does not differ. However, in GERD patients, refluxate is more often acidic
(pH<4) and liquid whereas it is more likely to be less acidic and gas-like in
healthy volunteers. Not all mechanisms that trigger TLESRs have been elicited,
however gastric distension and feedback mechanisms from the duodenum are known
to induce TLESRs.
Recently, we investigated the influence of side positioning in infants. We
demonstrated a reduction of number of TLESRs and liquid GER episodes in left
lateral position (LLP) compared to right lateral position (RLP). We
subsequently studied the effect of lateral side positioning during meals and
observed that the first TLESR in RLP is triggered much sooner and in some cases
directly after infusing minute amounts of an infant formula. Gastric
distension, nor duodenal feedback mechanisms can fully explain this early onset
of triggering TLESRs. The volume needed to trigger TLESRs and GER have not been
studied in adults and neither has the effect of posture on this.
Study objective
To investigate the influence of left and right lateral position on the onset of
TLESRs and GER and the underlying mechanisms during and after a test meal in
GERD patients compared to healthy controls.
Study design
A prospective, randomized, cross-over observational study. Patients and
controls will not be informed about previous findings about the influence of
posture on GER and TLESRs. Investigators will be blinded during the analysis.
Study burden and risks
Two nasogastric catheters will be inserted into the oesophagus and stomach.
Subjects will receive a test meal via one catheter. A non invasive gastric
emptying breathtest will be performed. Gastric volume scintigraphy using
intravenously administered 99mTc-pertechnetate will be performed. Three
questionnaires will be taken to assess gastrointestinal symptoms. This study
will take approximately 2 hours and will be repeated once in the other lateral
position. The above mentioned procedures might cause slight discomfort, but are
not harmful. The radiation burden is within the acceptable limits for research
with volunteers. Subject will not benefit directly from this study and will be
compensated with ยค100,-.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
GERD
* Written informed consent.
* >18 yr of age.
* 2 of the following criteria:
o GERD proved by pH-monitoring with reflux index >5.8% (Richter et al 1992).
o Combined pH-MII monitoring with SAP>95%
o Reflux esophagitis * grade I as confirmed by endoscopy.
* GERD symptoms > 3 months and >2x per week.
Healthy controls
* Written informed consent.
* >18 yr of age.
* No GERD symptoms or
Exclusion criteria
Exclusion criteria
* Previous gastro-intestinal surgery (with the exception of appendectomy).
* Any condition that will make it unsafe the subject to participate.
* Congenital abnormalities affecting the gastro-intestinal tract.
* Mental retardation.
* Hiatus hernia.
* Gravida.
* Any condition that will make discontinuation of medication impossible, as determined by the treating physician.
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 | NL26741.018.09 |