Our Objective is to show that the administration of prokinectics leads to an altered position of the acid pocket scintigraphically, and it thereby changes the rate of postprandial acid reflux episodes.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The number of reflux episodes. Acid, non acid and alkaline.
- The distance of the acid pocket to the crural diaphragm and LES
Secondary outcome
- The number of TLESRs
- Proximal extent of reflux episodes
- The rate of gastric emptying
Background summary
Gastro-esophageal reflux is a common phenomenon in which gastric contents flow
back into the esophageal lumen, which can cause symptoms and/ or esophageal
damage. Most reflux episodes occur during transient relaxations of the lower
esophageal sphincter (TLESR). The rate of TLESRs is however comparable in
healthy subjects and patients with gastro-esophageal reflux disease (GERD). In
contrast, several studies agree that the risk to have acidic reflux during a
TLESR is twice as large in GERD patients compared to healthy subjects.
Esophageal acid exposure is of great importance for development of symptoms
and/or esophageal damage.
Recently our lab has shown that the main factor in this difference is the
position of the postprandial acid pocket. The acid pocket is an unbuffered pool
of acid floating on top of the meal in the proximal stomach, where it is the
most important source of refluxate. By injection of 99mTc-pertechnetate we were
able to visualize this pool of acid scintigraphically, as 99mTc-pertechnetate
is also secreted by parietal cells in the stomach.
The most important finding of the study was that in patients with a large
hiatal hernia, the acid pocket may be trapped in the hiatal sac above the
diaphragm allowing acid reflux to occur during episodes of low LES pressure.
This explains the increased risk to have acidic gastroesophageal reflux during
a TLESR, when the LES relaxes after swallowing or when LES pressure is low in
patients with a hiatal hernia.
The macrolide Azitromycin is a bacterostatic antibiotic, with gastroprokinetic
properties. Erytromycin, a comparable macrolide alters proximal gastric volume
and postprandial relaxtion time. Administration of Azitromycine in patients
after lung transplant has shown to lower the rate of reflux episodes.
Interestingly, it mainly alters the rate of acidic reflux events, suggesting
that it alters the position of the acid pocket, as macrolides have no influence
on acid secretion or TLESRs. Therefore, our aim is to show that the
administration of Azitromycin leads to an altered position of the acid pocket
scintigraphically, and it thereby changes the rate of postprandial acid reflux
episodes.
Study objective
Our Objective is to show that the administration of prokinectics leads to an
altered position of the acid pocket scintigraphically, and it thereby changes
the rate of postprandial acid reflux episodes.
Study design
A double blind, placebo controlled, crossover, randomized trial.
Intervention
administration of azitromycin
Study burden and risks
Scintigraphy and esophageal manometry are safe and common procedures. The
utilization of prokinetics for patients with a hiatal hernia might show
valuable. Prokinetics are safe and well tolerated, and patients with a hiatus
hernia are generally patients wiith severe GERD.
Meibergdreef 9, postbus 22660
1100 DD Amsterdam
NL
Meibergdreef 9, postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
GERD patients with a hiatal hernia
- 18-65 years
- esophagitis and/or pH-metry with an acid exposure of > 4,5%
- hiatal hernia as seen on endoscopy or barium swallow of > 3 cm
GERD patients without a hiatal hernia
- 18-65 years
- esophagitis and/or pH-metry with an acid exposure of > 4,5%
- no hiatal hernia or a hiatal hernia < 2 cm as seen on endoscopy or barium swallow
Exclusion criteria
Exclusion criteria
- surgery of the gastrointestinal tract other then appendectomy
- use of medication that interfere with gastrointestinal motility
- inability to stop the use of proton pump inhibitors for one week
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 |
---|---|
EudraCT | EUCTR2009-013080-19-NL |
CCMO | NL27583.018.09 |