In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
The purpose of this study is:
- To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components.
- To differentiate the gastric sling fibers from the clasp fibers based on the spatial orientation of these muscle groups.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
The purpose of this research study is to examine and evaluate a part of the digestive system (gastrointestinal tract). The specific part the study team will look at is called the "lower esophageal sphincter complex." This complex is located where the esophagus (food pipe) meets the top of the stomach. The lower esophageal sphincter complex involves a group of muscles, and the study team hopes to better understand how they work.
The study team hopes that, by studying the lower esophageal sphincter complex, it may be possible to discover how it functions and what causes it to fail. When a complex fails, this can lead to reflux and heartburn. So learning more about the lower esophageal complex may help doctors' better treat future patients with reflux problems.
We plan to study these functions in normal control subjects, in patients with GERD (heartburn symptoms), and in patients with Barrett's esophagus (a change in the lining of the esophagus due to chronic reflux). The doctor performing the study procedure has previous experience with and is skilled in performing these procedures.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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New York
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New Hyde Park, New York, Förenta staterna, 11040
- LIJ Medical Center- NSLIJ Health System
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
Inclusion criteria for GERD patients are:
- Symptomatic heartburn
- Regurgitation
- Chest pain or water brash
Exclusion Criteria:
Exclusion criteria for normal volunteers include:
- Medications-Subjects on any medication which could effect the gastroesophageal junction high-pressure zone will be excluded, this includes use of antacids, H2 blockers, proton pump inhibitors, prokinetic agents, erythromycin type antibiotics and anticholinergics.
- GI symptoms, conditions and disorders
In addition exclusion criteria will include a history of:
- Esophagitis
- Gastrointestinal symptoms such as abdominal pain
- Heartburn
- Reflux
- Regurgitation
- Chest pain
- Difficulty swallowing
- Pain on swallowing
- Dysphagia
- Abdominal surgery involving the stomach or esophagus
- Nausea or vomiting
- Diabetes
- Scleroderma
- Esophageal motility disorders
- Non cardiac chest pain
- Achalasia and current pregnancy.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Normal Control
Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD
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GERD Patients
GERD patients are those with history of GERD, signs and symptoms of GERD and selected signs and symptoms of GERD in the questionnaire.
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Barrett's patients
Barrett's patients are those participants who in addition to all the qualities of GERD patients have long standing history of GERD and mucosal changes in the esophagus.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pressure at the gastric sling and clasp fibers
Tidsram: 5 years
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esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers
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5 years
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Larry S Miller, MD, Feinstein Institute for Medical Research
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R01DK059500 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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Kliniska prövningar på GERD
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Baylor Research InstituteHar inte rekryterat ännu
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Ohio State UniversityAvslutadGERDFörenta staterna
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EndoStim Inc.AvslutadGERDDanmark, Nederländerna, Tyskland, Österrike, Storbritannien, Argentina, Mexiko
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Chong Kun Dang PharmaceuticalAvslutadGERDKorea, Republiken av
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Chong Kun Dang PharmaceuticalAvslutadGERDKorea, Republiken av
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Chong Kun Dang PharmaceuticalAvslutadGERDKorea, Republiken av
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Yooyoung Pharmaceutical Co., Ltd.Avslutad
-
Chong Kun Dang PharmaceuticalAvslutad
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Dr. Reddy's Laboratories LimitedAvslutad