No registrations found.
ID
Source
Health condition
GERD
Gastro-esophageal reflux disease
GORZ
gastro-oesofageale reflux ziekte
Sponsors and support
Academic Medical Center
Academic Medical Center
Intervention
Outcome measures
Primary outcome
Primary outcome is the number of acid reflux episodes detected on pH-impedance measurements.
Secondary outcome
Secondary outcomes are postprandial esophageal acid exposure, the rate of acid versus non acid reflux events, the number of non acid reflux events and the position of the acid pocket, relative to the crural diaphragm.
Background summary
The gastric acid pocket is the most important source of refluxate. It is hypothesized that very commonly used alginate-antacid formulations form a floating raft on top of the acid pocket. This is however never visualized in vivo. To visualize the alginate raft formation and to assess the effect of this raft formation on reflux parameters, we aimed to perform a randomised controlled study in which we compared Gaviscon, a alginate-antacid formulation to Antagel, a commonly used antacid.
We will compare these two over the counter medications in one postprandial measurement using pH-impedance testing to detect reflux episodes.
Study objective
We hypothesize that after alginate intake a raft is formed in the proximal stomach proximal of the gastric acid pocket, and that this raft affects the gastric acid pocket regarding acidity, position and size leading to less acid reflux events.
Study design
Patients undergo 1 postprandial measurement.
Intervention
1. The use of proton pump inhibitors has to be stopped 5-7 days prior to the study day;
2. On the study day, 350MBq Tc-pertechnetate is injected intravenously;
3. Randomized single oral administration of either 10 mL Gaviscon (Indium-labelled) or 10 mL Antagel;
4. Esophageal high-resolution manometry/pH-manometry to detect reflux eipsodes during 2 postprandial hours;
5. Scintigraphy.
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
Inclusion criteria
1. GERD confirmed by pH-impedance (ph<4 in > 4,5 % of time or positive symptom association), or in patients with reflux esophagitis;
2. Written informed consent;
3. 18-75 years.
Exclusion criteria
1. Surgery of the gastrointestinal tract other than appendectomy;
2. Inability to stop the use of proton pump inhibitors for one week;
3. Participation in another study with exposure to radiation;
4. Participation in another study within the last year;
5. Long segment of Barrett’s epithelium.
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 |
|---|---|
| NTR-new | NL3451 |
| NTR-old | NTR3602 |
| Other | MEC / CCMO : 11/279 / Nl37764.018.11; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
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Beaumont H, Bennink RJ, de Jong J et al. The position of the acid pocket as a major risk factor for acidic reflux in healthy subjects and patients with GORD. Gut 2010;59(4):441-51.
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Rohof WO, Bennink RJ, Hirsch DP et al. Effect of azithromycin on acid reflux, hiatus hernia and proximal acid pocket in the postprandial period. Gut. 2012 Jan 20. [Epub ahead of print].