GERDEAISMLPNCT03600974
A New System for GERD Diagnosis and Treatment
An observational study of GERD, run by Capital Medical University.
Trial summary
This is a pilot study measuring a new diagnosis and treatment system "EAISMLP" in adult patients with gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- GERD
- What is being tested?
- Stretta, Laparoscopic Nissen fundoplication and Probiotic Agent
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with refractory gastroesophageal refulx symptoms.
Who may be able to join
- Male or Female aged ≥18 years
- 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.
- Decided to participate and signed on an informed consent form willingly.
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
This is a pilot study measuring a new diagnosis and treatment system "EAISMLP" in adult patients with gastroesophageal reflux disease (GERD).
Read the 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.
- Conditions
- GERD
- Being tested
- Stretta, Laparoscopic Nissen fundoplication, Probiotic Agent, PPI, Prokinetic Motility Agents
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrettaProcedure or surgery
Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group
Laparoscopic Nissen fundoplicationProcedure or surgery
Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group
Probiotic AgentDrug
Also called Live Bacillus Licheniformis Cranules, Bifidbacterium
Probiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid
PPIDrug
Also called omeprazole, lansoprazole, Rabeprazole, Esomeprazole
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
Prokinetic Motility AgentsDrug
Also called Mosapride, Domperidone
Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid
NeuromodulatorsDrug
Also called Flupentixol and Melitracen, Citalopram
Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy-E(+) | Subjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Neuromodulators | |
| psychology-P(-) | Subjects with abnormal psychology condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
mean improvement in SF-36 scores.Scale ranges 0-100 points, the higher score means the better efficacy.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Feb 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Zihao, Capital Medical University
- Investigators
- Chuan Zhang, MD, Study chair, Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600974
- Sponsor's protocol ID
- xhnk002
- Acronym
- EAISMLP
- Status last verified
- Feb 2019
- First submitted
- 21 Jun 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03600974
- Acronym / sponsor ID
- EAISMLP / xhnk002
- Conditions
- GERD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Endoscopy-E(+) | – | Procedure: Stretta, Procedure: Laparoscopic Nissen fundoplication, Drug: PPISubjects with positive endoscopy finding:erosive esophagitis or Barrett esophagus.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered. |
| Endoscopy-E(-) | – | –Subjects with negative endoscopy finding:NERD. |
| Acid-A(+) | – | Procedure: Stretta, Procedure: Laparoscopic Nissen fundoplication, Drug: PPISubjects with DeMeester scores>14.72.For subjects of this group, PPIs, Stretta,Laparoscopic Nissen fundoplication is considered. |
| Acid-A(-) | – | –Subjects with DeMeester scores<14.72 |
| impedance-I（+）W/S | – | Drug: Probiotic AgentSubjects 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. |
| impedance-I（-） | – | –Subjects with total reflux number < 80 in 24h pH-impedance monitoring. |
| Reflux-symptom association-S(+) | – | Procedure: Stretta, Drug: PPI, Drug: NeuromodulatorsSubjects with positive reflux-symptom association.For subjects of this group, PPIs, Stretta, neuromodulators are considered. |
| Reflux-symptom association-S(-) | – | –Subjects with negative reflux-symptom association |
| motility-M(+) | – | Drug: Prokinetic Motility AgentsSubjects with motility disorders according to Chicago v3.0.For subjects of this group, prokinetic motility agents are considered. |
| motility-M(-) | – | –Subjects without motility disorders according to Chicago v3.0 |
| lower oesophageal sphincter-L(+) | – | Procedure: Stretta, Procedure: Laparoscopic Nissen fundoplicationSubjects with abnormal LES pressure or EGJ type III or hiatus hernia.For subjects of this group, Stretta,Laparoscopic Nissen fundoplication is considered. |
| lower oesophageal sphincter-L(-) | – | –Subjects with normal LES pressure and EGJ type I~II |
| psychology-P(+) | – | Drug: NeuromodulatorsSubjects with normal psychology condition.For subjects of this group,neuromodulators are considered. |
| psychology-P(-) | – | –Subjects with abnormal psychology condition |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with refractory gastroesophageal refulx symptoms.
Key inclusion criteria (5 listed)
- Male or Female aged ≥18 years
- 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.
- Decided to participate and signed on an informed consent form willingly.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrettaStretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group | Procedure or surgery | Acid-A(+), Endoscopy-E(+), Reflux-symptom association-S(+), lower oesophageal sphincter-L(+) |
| Laparoscopic Nissen fundoplicationLaparoscopic Nissen fundoplication for E(+),A(+) or L(+) group | Procedure or surgery | Acid-A(+), Endoscopy-E(+), lower oesophageal sphincter-L(+) |
| Probiotic AgentAlso: Live Bacillus Licheniformis Cranules, BifidbacteriumProbiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid | Drug | impedance-I（+）W/S |
| PPIAlso: omeprazole, lansoprazole, Rabeprazole, EsomeprazolePPIs 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 | Drug | Acid-A(+), Endoscopy-E(+), Reflux-symptom association-S(+) |
| Prokinetic Motility AgentsAlso: Mosapride, DomperidoneProkinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid | Drug | motility-M(+) |
| NeuromodulatorsAlso: Flupentixol and Melitracen, CitalopramNeuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid; | Drug | Reflux-symptom association-S(+), psychology-P(+) |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuan Zhang, MD study chair
Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Zi Guo, MD (86+15801227696, zihaoguo@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.