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

The effect of Gaviscon on acid reflux episodes and on the position of the gastric acid pocket: A Scintigraphic study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25536
Enrollment
16
Registered
2012-09-04
Start date
2012-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD Gastro-esophageal reflux disease GORZ gastro-oesofageale reflux ziekte

Interventions

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.

Sponsors

Prof. dr. G.E. Boeckxstaens Academic Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. GERD confirmed by pH-impedance (ph 4,5 % of time or positive symptom association), or in patients with reflux esophagitis; 2. Written informed consent; 3. 18-75 years.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Primary outcome is the number of acid reflux episodes detected on pH-impedance measurements.

Secondary

MeasureTime frame
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.

Contacts

Public ContactG.E.E. Boeckxstaens

Academic Medical Center (AMC), Department of Gastroenterology, C2-328, P.O. Box 22660

g.e.boeckxstaens@amc.uva.nl+31 (0)20 5667375

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)