GERD
Conditions
Brief summary
This is a pilot study measuring a new diagnosis and treatment system EAISMLP in adult patients with gastroesophageal reflux disease (GERD).
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.
Interventions
PROCEDUREStretta
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group
DRUGPPI
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
PROCEDURELaparoscopic Nissen fundoplication
Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group
DRUGProbiotic Agent
Probiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid
DRUGProkinetic Motility Agents
Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid
DRUGNeuromodulators
Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;
Sponsors
Capital Medical University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of the EAISMLP system on GERD symptoms assessed by the HRQL scores. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | mean improvement in SF-36 scores.Scale ranges 0-100 points, the higher score means the better efficacy. |
Contacts
Primary ContactHao Zi Guo, MD
Outcome results
None listed