Ignite Creation Date:
2024-05-06 @ 2:30 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02054455
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2012-04-11
Brief Title:
Proton Pump Inhibitors and Gastrointestinal Symptoms
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Protective Effects of Probiotic Administration on SIBO Development and Bowel Symptom Onset in GERD Patients at Long-term PPI Treatment a Randomized Controlled Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to evaluate the potential protective effect of Lactobacillus paracasei subspecies paracasei F19 administration on bowel symptom onset in patients with gastro-esophageal reflux disease at long-term PPI treatment
Detailed Description:
Population and study design
After the approval of the Local Ethical Committee and informed consent of patients we will consecutively enrol according to the calculated power of the study 80 outpatients among those referred to the Institutional centers on account of recent onset of typical reflux symptoms heartburn and regurgitation
Exclusion criteria will be age 18 or 70 yrs pregnancy or breast-feeding evidence of major concomitant diseases ie tumors cardiovascular disorders and hepatic andor renal failure use of PPIs or H2-antagonists non-steroidal anti-inflammatory drugs NSAIDs or antibiotics in the previous 3 months presence of Helicobacter pylori H pylori infection erosive esophagitis presence of bowel symptoms such as bloating flatulence abdominal pain diarrhea and constipation in the last 6 months or irritable bowel syndrome IBS according to Rome III criteria
All patients will undergo upper endoscopy Patients who will fulfill the entry criteria will be enrolled in the study
These patients will be treated with pantoprazole 40 mg die for 6 months and they will be randomly assigned to 4 arms
the first arm will receive placebo for 3 daysweek for 6 months
the second arm will receive LP-F19 in a dose of 25x109 live bacterial cells for 3 daysweek for 6 months
the third arm will receive LP-F19 in a dose of 25x109 live bacterial cells for 3 daysweek for the first three months and placebo 3 daysweek for the following three months
the fourth arm will receive placebo 3 daysweek for the first three months and LP-F19 in a dose of 25x109 live bacterial cells for 3 daysweek for the following three months
Placebo will consist of a preparation similar to that of probiotic but with no added microorganisms
Adherence to treatment Will be evaluated based on self-reporting by the patients and count of returned sackets during monthly control visits Patients who will take at least 90 of the drugs pantoprazole LP-F19 and placebo for at least 90 of the scheduled time will be considered compliant
Before starting therapy ie baseline evaluation and every 4 weeks each patient will fill up a structured questionnaire for symptom assessment concerning heartburn and regurgitation as well as bowel symptoms including bloating abdominal pain flatulence and bowel habit
Symptom and bowel habit assessment
Baseline and every 4 weeks after the beginning of the therapy each patient will fill up a structured questionnaire focusing on the presence of heartburn regurgitation bloating flatulence abdominal pain diarrhea and constipation with the help of a physician interviewer The questionnaire according to a Likert scale will assess frequency 0 never 1 1 episodeweek 2 3 episodesweek 3 3 episodesweek 4 daily episodes and severity 0 absent 1 mild ie not interfering with the daily activities 2 moderate ie limiting the daily activities and 3 severe ie hampering the daily activities of each symptom during the previous 6 months at baseline and during the last month at every 4-week checkpoints According to an arbitrary index symptoms will be considered significant when interfering with daily activities ie mean total score frequency plus severity 4
Subjects will record their bowel habit on validated diary cards including every single stool and stool consistency Stool consistency will be deļ¬ned according to the Bristol Stool Form Scale BSFS Diary cards will be returned every four weeks
After the approval of the Local Ethical Committee and informed consent of patients we will consecutively enrol according to the calculated power of the study 80 outpatients among those referred to the Institutional centers on account of recent onset of typical reflux symptoms heartburn and regurgitation
Exclusion criteria will be age 18 or 70 yrs pregnancy or breast-feeding evidence of major concomitant diseases ie tumors cardiovascular disorders and hepatic andor renal failure use of PPIs or H2-antagonists non-steroidal anti-inflammatory drugs NSAIDs or antibiotics in the previous 3 months presence of Helicobacter pylori H pylori infection erosive esophagitis presence of bowel symptoms such as bloating flatulence abdominal pain diarrhea and constipation in the last 6 months or irritable bowel syndrome IBS according to Rome III criteria
All patients will undergo upper endoscopy Patients who will fulfill the entry criteria will be enrolled in the study
These patients will be treated with pantoprazole 40 mg die for 6 months and they will be randomly assigned to 4 arms
the first arm will receive placebo for 3 daysweek for 6 months
the second arm will receive LP-F19 in a dose of 25x109 live bacterial cells for 3 daysweek for 6 months
the third arm will receive LP-F19 in a dose of 25x109 live bacterial cells for 3 daysweek for the first three months and placebo 3 daysweek for the following three months
the fourth arm will receive placebo 3 daysweek for the first three months and LP-F19 in a dose of 25x109 live bacterial cells for 3 daysweek for the following three months
Placebo will consist of a preparation similar to that of probiotic but with no added microorganisms
Adherence to treatment Will be evaluated based on self-reporting by the patients and count of returned sackets during monthly control visits Patients who will take at least 90 of the drugs pantoprazole LP-F19 and placebo for at least 90 of the scheduled time will be considered compliant
Before starting therapy ie baseline evaluation and every 4 weeks each patient will fill up a structured questionnaire for symptom assessment concerning heartburn and regurgitation as well as bowel symptoms including bloating abdominal pain flatulence and bowel habit
Symptom and bowel habit assessment
Baseline and every 4 weeks after the beginning of the therapy each patient will fill up a structured questionnaire focusing on the presence of heartburn regurgitation bloating flatulence abdominal pain diarrhea and constipation with the help of a physician interviewer The questionnaire according to a Likert scale will assess frequency 0 never 1 1 episodeweek 2 3 episodesweek 3 3 episodesweek 4 daily episodes and severity 0 absent 1 mild ie not interfering with the daily activities 2 moderate ie limiting the daily activities and 3 severe ie hampering the daily activities of each symptom during the previous 6 months at baseline and during the last month at every 4-week checkpoints According to an arbitrary index symptoms will be considered significant when interfering with daily activities ie mean total score frequency plus severity 4
Subjects will record their bowel habit on validated diary cards including every single stool and stool consistency Stool consistency will be deļ¬ned according to the Bristol Stool Form Scale BSFS Diary cards will be returned every four weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None