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A New System for GERD Diagnosis and Treatment (EAISMLP)

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ClinicalTrials.gov Identifier: NCT03600974
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Guo Zihao, Capital Medical University

Brief Summary:
This is a pilot study measuring a new diagnosis and treatment system "EAISMLP" in adult patients with gastroesophageal reflux disease (GERD).

Condition or disease Intervention/treatment
GERD Procedure: Stretta Procedure: Laparoscopic Nissen fundoplication Drug: Probiotic Agent Drug: PPI Drug: Prokinetic Motility Agents Drug: Neuromodulators

Detailed Description:
The investigators created a new diagnosis and treatment system for gastroesophageal reflux disease (GERD). The system based on endoscopy, 24h esophageal pH-impedance monitoring, esophagus high resolution manometry and psycological condition.the investigators named it as "EAISMLP" symptom. Each letter in "EAISMLP" is responsible for a typical character and treatment. Subjects will be subtyped according to "EAISMLP" system and underwent treatment, and will be follow up for 6 months and 1 years.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A New System for Diagnosis and Treatment of Gastroesophageal Refulx Diseases : Based on Endoscopy, pH Parameter, Impedence Parameter, High Resolution Manometry and Psychology
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Group/Cohort Intervention/treatment
Endoscopy-E(+)
Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
Procedure: Stretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Procedure: Laparoscopic Nissen fundoplication
Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group

Drug: PPI
PPIs for A(+),E(+)or S(+) patients: Nexium 20mg Qd/Bid;Lansoprazole 30mg Qd/Bid;omeprazole 10mg-30mg Qd-Bid;Rabeprazole 10mg Qd/Bid;Esomeprazole 20mg Qd/Bid;Pantoprazole 40mg Qd/Bid
Other Names:
  • omeprazole
  • lansoprazole
  • Rabeprazole
  • Esomeprazole
  • Pantoprazole

Endoscopy-E(-)
Subjects with negative endoscopy finding:NERD.
Acid-A(+)
Subjects with DeMeester scores>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered.
Procedure: Stretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Procedure: Laparoscopic Nissen fundoplication
Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group

Drug: PPI
PPIs for A(+),E(+)or S(+) patients: Nexium 20mg Qd/Bid;Lansoprazole 30mg Qd/Bid;omeprazole 10mg-30mg Qd-Bid;Rabeprazole 10mg Qd/Bid;Esomeprazole 20mg Qd/Bid;Pantoprazole 40mg Qd/Bid
Other Names:
  • omeprazole
  • lansoprazole
  • Rabeprazole
  • Esomeprazole
  • Pantoprazole

Acid-A(-)
Subjects with DeMeester scores<14.72
impedance-I(+)W/S
Subjects with total reflux number > 80 in 24h pH-impedance monitoring. W means weakly acid reflux account for above 50% in total reflux number. G means gas reflux account for above 50% in total reflux number.For subjects of this group,probiotic agent is considered.
Drug: Probiotic Agent
Probiotic Agent for I(+)G/W;Live Bacillus Licheniformis Cranules 0.5g bid; Bifidbacterium 0.63g bid
Other Names:
  • Live Bacillus Licheniformis Cranules
  • Bifidbacterium

impedance-I(-)
Subjects with total reflux number < 80 in 24h pH-impedance monitoring.
Reflux-symptom association-S(+)
Subjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered.
Procedure: Stretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Drug: PPI
PPIs for A(+),E(+)or S(+) patients: Nexium 20mg Qd/Bid;Lansoprazole 30mg Qd/Bid;omeprazole 10mg-30mg Qd-Bid;Rabeprazole 10mg Qd/Bid;Esomeprazole 20mg Qd/Bid;Pantoprazole 40mg Qd/Bid
Other Names:
  • omeprazole
  • lansoprazole
  • Rabeprazole
  • Esomeprazole
  • Pantoprazole

Drug: Neuromodulators
Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;
Other Names:
  • Flupentixol and Melitracen
  • Citalopram

Reflux-symptom association-S(-)
Subjects with negative reflux-symptom association
motility-M(+)
Subjects with motility disorders according to Chicago v3.0.For subjects of this group, prokinetic motility agents are considered.
Drug: Prokinetic Motility Agents
Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid
Other Names:
  • Mosapride
  • Domperidone

motility-M(-)
Subjects without motility disorders according to Chicago v3.0
lower oesophageal sphincter-L(+)
Subjects with abnormal LES pressure or EGJ type III or hiatus hernia.For subjects of this group, Stretta,Laparoscopic Nissen fundoplication is considered.
Procedure: Stretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Procedure: Laparoscopic Nissen fundoplication
Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group

lower oesophageal sphincter-L(-)
Subjects with normal LES pressure and EGJ type I~II
psychology-P(+)
Subjects with normal psychology condition.For subjects of this group,neuromodulators are considered.
Drug: Neuromodulators
Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;
Other Names:
  • Flupentixol and Melitracen
  • Citalopram

psychology-P(-)
Subjects with abnormal psychology condition



Primary Outcome Measures :
  1. Satisfaction of the "EAISMLP system" on GERD symptoms assessed by the HRQL scores. [ Time Frame: Change from Baseline HRQL scores at 1 month;Change from Baseline HRQL scores at 2 months;Change from Baseline HRQL scores at 6 months;Change from Baseline HRQL scores at 1 year ]
    mean improvement in the GERD-health-related quality of life (HRQL) scores. Scale ranges 0-50 points, the lower score means the better efficacy.


Secondary Outcome Measures :
  1. Satisfaction of the "EAISMLP system" on life quality assessed by the SF-36 scores. [ Time Frame: Change from Baseline SF-36 scores at 1 month;Change from Baseline SF-36 scores at 2 months;Change from Baseline SF-36 scores at 6 months;Change from Baseline SF-36 scores at 1 year ]
    mean improvement in SF-36 scores.Scale ranges 0-100 points, the higher score means the better efficacy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects with refractory gastroesophageal refulx symptoms.
Criteria

Inclusion Criteria:

  1. Male or Female aged ≥18 years
  2. Subjects with refractory reflux symptoms to PPIs standard treatment as follows:

    2.1 Ongoing heartburn symptom with or without these GERD-related symptoms : Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating, Satiety, Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia, Odynophagia, Weight loss.

    2.2 Ongoing heartburn symptom with or without erosion ≥ grade A according to LA Classification.

  3. Decided to participate and signed on an informed consent form willingly.

Exclusion Criteria:

  1. Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening.
  2. History of operation in esophagus, stomach or duodenum.
  3. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/ pyloric stricture, Primary esophageal spasm, Barrett's esophagus ≥ 3 cm, Zollinger-Ellison syndrome.
  4. Infectious or inflammatory bowel disease, Severe malabsorption, Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis.
  5. History of cancer within 5 years, except completely recovered skin cancer ALT or AST ≥ Upper limit of normal range X 3.
  6. Need antibiotics due to severe infection.
  7. Pregnant or breast-feeding women.
  8. Conversation impairment because of alcohol, drug addiction or mental illness, etc.
  9. Inability to record diary card
  10. In investigator's judgement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600974


Contacts
Contact: Hao Zi Guo, MD 86+15801227696 zihaoguo@139.com

Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Chuan Zhang, MD Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University

Responsible Party: Guo Zihao, Principal Investigator, Capital Medical University
ClinicalTrials.gov Identifier: NCT03600974     History of Changes
Other Study ID Numbers: xhnk002
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be avialable within 1 months of study completion.
Access Criteria: Data access requests will be reviewed by an external independant Review Panel. Requestors will be required to sign a Data Access Agreement.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Omeprazole
Esomeprazole
Pantoprazole
Rabeprazole
Lansoprazole
Dexlansoprazole
Mosapride
Domperidone
Flupenthixol
Flupenthixol decanoate
Neurotransmitter Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin Receptor Agonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs