A New System for GERD Diagnosis and Treatment

NCT03600974 | Unknown DMC

• 1 other identifier: xhnk002
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• Satisfaction of the "EAISMLP system" on GERD symptoms assessed by the HRQL scores.

  mean improvement in the GERD-health-related quality of life (HRQL) scores. Scale ranges 0-50 points, the lower score means the better efficacy.

  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

Secondary Outcomes (1)

• Satisfaction of the "EAISMLP system" on life quality assessed by the SF-36 scores.

  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

Study Arms (14)

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; Procedure: Laparoscopic Nissen fundoplication; Drug: PPI

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; Procedure: Laparoscopic Nissen fundoplication; Drug: PPI

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

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; Drug: PPI; Drug: Neuromodulators

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

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; Procedure: Laparoscopic Nissen fundoplication

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

psychology-P(-)

Subjects with abnormal psychology condition

Interventions

Stretta PROCEDURE

Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group

Acid-A(+); Endoscopy-E(+); Reflux-symptom association-S(+); lower oesophageal sphincter-L(+)

Laparoscopic Nissen fundoplication PROCEDURE

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

Acid-A(+); Endoscopy-E(+); lower oesophageal sphincter-L(+)

Probiotic Agent DRUG

Probiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid

Also known as: Live Bacillus Licheniformis Cranules, Bifidbacterium

impedance-I（+）W/S

PPI DRUG

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

Also known as: omeprazole, lansoprazole, Rabeprazole, Esomeprazole, Pantoprazole

Acid-A(+); Endoscopy-E(+); Reflux-symptom association-S(+)

Prokinetic Motility Agents DRUG

Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid

Also known as: Mosapride, Domperidone

motility-M(+)

Neuromodulators DRUG

Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;

Also known as: Flupentixol and Melitracen, Citalopram

Reflux-symptom association-S(+); psychology-P(+)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with refractory gastroesophageal refulx symptoms.

You may qualify if:

• Male or Female aged ≥18 years
• Subjects with refractory reflux symptoms to PPIs standard treatment as follows:
• 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.
• Ongoing heartburn symptom with or without erosion ≥ grade A according to LA Classification.
• Decided to participate and signed on an informed consent form willingly.

You may not qualify if:

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

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Omeprazole; Lansoprazole; Rabeprazole; Esomeprazole; Pantoprazole; mosapride; Domperidone; Neurotransmitter Agents; flupentixol, melitracen drug combination; Citalopram

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Propylamines; Amines; Nitriles; Benzofurans

Study Officials

• Chuan Zhang, MD

  Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University

  STUDY CHAIR

Central Study Contacts

Hao Zi Guo, MD

CONTACT

86+15801227696; zihaoguo@139.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 26, 2018
• Study Start: February 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2021
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.