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Measurement of Gastric Secretion by MRI Under Inhibition by ProtonPump Inhibitors in Healthy Subjects & in GERD Patients

NCT ID: NCT01212614

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-09-30

Brief Summary

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This study bases on the successfully completed project SNF 320000-112006 (EK 1152 and SwissMedic 2005dr2207e) and will document the physiological effects of inhibited gastric secretion on the volume as well as the acidity of gastric secretion by high dose proton pump inhibitors in GERD patients and healthy controls. Twelve participants in each group will be studied in a randomized, double-blind placebo controlled trial. A novel non-invasive MRI technique developed in Zurich will assess the volume of gastric secretion following the ingestion of a regular liquid meal. In addition, intragastric / esophageal pH monitoring will assess the link between volume and intragastric distribution of gastric secretion on reflux events and symptoms. In addition, the effect of gastric secretion on outcome parameters of a non-invasive stable isotope breath test for measurement of gastric emptying will be assessed.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring

MRI, non invasive 13C-breath test, 24h-intragastric/esophageal pH monitoring

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Reflux patients (GERD) must have chronic symptoms (\>8 weeks) suggestive for GERD (definition and questionnaire see Appendix page 30). In addition, the initial screening manometry must show no severe esophageal dysmotility (e.g. spasm, achalasia). If in addition a pH-study has been performed the acid exposure must be \> 4.2% / 24h.

Exclusion Criteria

* Pathologic underweight or overweight (BMI \< 18 or \> 30 kg/m2)
* Previous history of gastrointestinal disease or surgery (excludes appendectomy, cholecystectomy, hernia repair and anorectal disorders)
* Previous cardiorespiratory (excludes arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disease, diabetes, drug or alcohol abuse
* Patient unable to stop medication that alters gut function for 72 hours prior to the study, including anticholinergics, prokinetics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs
* Positive Helicobacter pylori status on 13C-Urea breath test
* Presence of metallic implants, devices or metallic foreign bodies
* Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)
* Female volunteers without adequate contraception for the duration of the study
* Involvement in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Werner Schwizer, Professor MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Gastroenterology and Hepatology

Locations

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University of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Steingoetter A, Sauter M, Curcic J, Liu D, Menne D, Fried M, Fox M, Schwizer W. Volume, distribution and acidity of gastric secretion on and off proton pump inhibitor treatment: a randomized double-blind controlled study in patients with gastro-esophageal reflux disease (GERD) and healthy subjects. BMC Gastroenterol. 2015 Sep 2;15:111. doi: 10.1186/s12876-015-0343-x.

Reference Type DERIVED
PMID: 26328588 (View on PubMed)

Other Identifiers

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KEK-ZH-Nr. 2010-0293

Identifier Type: -

Identifier Source: org_study_id