Gastro Esophageal RefluxEarly Phase 1NCT04400136
PPI Therapy Impact on GERD After Sleeve Gastrectomy
A Early Phase 1 study testing Lansoprazole oral tablets 30 mg in people with Gastro Esophageal Reflux and Barrett Esophagus, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The trial would to try to establish: The best post-operative PPI prescription protocol after Sleeve Gastrectomy The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett) The impact of PPI therapy on post-operative GERD symptoms (assessed with the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastro Esophageal Reflux, Barrett Esophagus, Bariatric Surgery Candidate
- What is being tested?
- Lansoprazole oral tablets 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2020to 1 Sep 2022
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients candidates for primary SG
- Patients adhering to the follow-up protocol
- Age between 18 and 65 years
- No BMI limits
Who cannot join
- Gastric and/or esophageal diseases (routine preoperative endoscopy)
- Patients candidate for revisional bariatric surgery
- Chronic preoperative PPI therapy
- Using of PPI treatment for postoperative complications
- Conversion to open surgery
- Patients allergic to PPI
- Patients undergoing concomitant surgery
- Patients with hiatal hernia undergoing concomitant cruroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study
The trial would to try to establish:
- The best post-operative PPI prescription protocol after Sleeve Gastrectomy
- The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett)
- The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ
Read the detailed description
45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group)
GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months
GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months
- Being tested
- Lansoprazole oral tablets 30 mg
- Keywords
- reflux, PPI, sleeve gastrectomy
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole oral tablets 30 mgDrug
Also called PPI tablet
Post operative prescription
| Study group | Role | What they receive |
|---|---|---|
| GROUP A - no PPI | No intervention | no PPI treatment (control group) |
| GROUP B PPI 1/day for 6 months | Experimental | (standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months Receives: Drug: Lansoprazole oral tablets 30 mg |
| GROUP C PPI 1/day for 3 months | Experimental | (standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months Receives: Drug: Lansoprazole oral tablets 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of post-operative GERD based on the trial protocol. Clinical evaluation
Questionnaire evaluation (GERD-HRQL score from 0 (no symptoms) to 5 (symptoms worsening daily activity) and GERD-Q (score A <8 no GERD, score A >8 and B > 3 GERD worsening normal life)
Measured: 12 months
Secondary outcomes (1)
evaluate in each group of the study (arm type) the endoscopic finding of peptic lesions of the esophagus-gastro-duodenal mucosa at 24 months of follow-up
Mucosal damage evaluation and stratified accordingly
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Iossa, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400136
- Sponsor's protocol ID
- Lasapienza2020
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study
- ClinicalTrials.gov ID
- NCT04400136
- Acronym / sponsor ID
- Lasapienza2020
- Keywords
- reflux, PPI, sleeve gastrectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 22 May 2020 (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.
The trial would to try to establish:
- The best post-operative PPI prescription protocol after Sleeve Gastrectomy
- The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett)
- The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ
Detailed description
45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group)
GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months
GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP A - no PPI | No intervention | –no PPI treatment (control group) |
| GROUP B PPI 1/day for 6 months | Experimental | Drug: Lansoprazole oral tablets 30 mg(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months |
| GROUP C PPI 1/day for 3 months | Experimental | Drug: Lansoprazole oral tablets 30 mg(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients candidates for primary SG
- Patients adhering to the follow-up protocol
- Age between 18 and 65 years
- No BMI limits
Key exclusion criteria (8 listed)
- Gastric and/or esophageal diseases (routine preoperative endoscopy)
- Patients candidate for revisional bariatric surgery
- Chronic preoperative PPI therapy
- Using of PPI treatment for postoperative complications
- Conversion to open surgery
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 |
|---|---|---|
| Lansoprazole oral tablets 30 mgAlso: PPI tabletPost operative prescription | Drug | GROUP B PPI 1/day for 6 months, GROUP C PPI 1/day for 3 months |
Primary outcome
Percentage of post-operative GERD based on the trial protocol. Clinical evaluation
Time frame: 12 months
Questionnaire evaluation (GERD-HRQL score from 0 (no symptoms) to 5 (symptoms worsening daily activity) and GERD-Q (score A <8 no GERD, score A >8 and B > 3 GERD worsening normal life)
1 secondary outcome
evaluate in each group of the study (arm type) the endoscopic finding of peptic lesions of the esophagus-gastro-duodenal mucosa at 24 months of follow-up
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lansoprazole oral tablets 30 mg in people with Gastro Esophageal Reflux and Barrett Esophagus, run by University of Roma La Sapienza at 1 site in Italy.
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 4 inclusion and 8 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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of post-operative GERD based on the trial protocol. Clinical evaluation (time frame: 12 months). 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 22 May 2020.