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De invloed van Gaviscon op de acid pocket en zure reflux.

- candidate number13286
- NTR NumberNTR3602
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2012
- Secondary IDs11/279 / Nl37764.018.11; MEC / CCMO
- Public TitleDe invloed van Gaviscon op de acid pocket en zure reflux.
- Scientific TitleThe effect of Gaviscon on acid reflux episodes and on the position of the gastric acid pocket: A Scintigraphic study.
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate1-okt-2012
- Target number of participants16
- Interventions1. 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.
- Primary outcomePrimary outcome is the number of acid reflux episodes detected on pH-impedance measurements.
- Secondary outcomeSecondary 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.
- TimepointsPatients undergo 1 postprandial measurement.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- PublicationsPrevious publications on this subject from our group:

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.

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].
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD4-sep-2012 - 22-sep-2012

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