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Trial details
Trial details
Gastroesophageal Reflux Disease and Probiotics
Current status:
Approved
|
Date registered:
21/11/2023
|
Date last updated:
14/11/2023
Trial version(s)
Current: 31/10/2023
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Main Information
Primary registry identifying number
LBCTR2023105464
Protocol number
LBCTR2023105464
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
31/10/2023
Primary sponsor
Lebanese American University
Primary sponsor: Country of origin
Lebanon
Public title
Gastroesophageal Reflux Disease and Probiotics
Acronym
Scientific title
Gastroesophageal Reflux Disease and Probiotics
Acronym
GERD and Probiotics
Brief summary of the study: English
In this study we aim at determining if GERD symptoms are alleviated by the administration of certain strains of Gram-positive organisms administered as probiotics. The expected duration of the study is 2 months. It is an experimental study whereby we are trying to determine if the administration of probiotics would alleviate reflux symptoms. The approximate number of participants to be included is 400.
Brief summary of the study: Arabic
نهدف في هذه الدراسة إلى تحديد ما إذا كانت أعراض الارتجاع المعدي المريئي يتم تخفيفها عن طريق إعطاء سلالات معينة من الكائنات إيجابية الجرام التي يتم تناولها كبروبيوتيك. المدة المتوقعة للدراسة شهرين. إنها دراسة تجريبية نحاول من خلالها تحديد ما إذا كان إعطاء البروبيوتيك سيخفف من أعراض الارتجاع. العدد التقريبي للمشاركين الذين سيتم تضمينهم هو 400.
Health conditions/problem studied: Specify
Gastroesophageal Reflux Disease
Interventions: Specify
Probiotics
Key inclusion and exclusion criteria: Inclusion criteria
• Patients with mild to moderate GERD symptoms (diagnosed on basis of clinical presentation) • Patients with GERD regardless of prior treatment for GERD but not currently on PPIs over at least 4 weeks
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
50
Key inclusion and exclusion criteria: Exclusion criteria
• Patients less than 18 years or above the age of 50 • Prior bariatric surgery • Epigastric mass • Prior endoscopy showing severe erosive esophagitis LA-C or LA-D • Alarm symptoms: weight loss, anemia, dysphagia or odynophagia, family history of malignancy, melena, hematemesis, nausea and vomiting • Pregnant women • Malignancy, IBD, immunosuppressive therapy • Advanced cardiac disease • Chronic uninterrupted use of PPI • ESRD • Use of probiotics within the last 6 months
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
N/A
Study design: Purpose
Treatment
Study design: Assignment
Other
Study design: Specify assignment
Placebo-Controlled
IMP has market authorization
Yes, Lebanon
Name of IMP
Probiolife
Type of IMP
Others
Type of IMP: Specify
Probiotic
Pharmaceutical class
Probiotic
Therapeutic indication
Gastroesophageal reflux disease symptoms
Therapeutic benefit
Possible resolution or decrease of gastroesophageal reflux disease symptoms
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
400
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
15/11/2023
Date of study closure: Type
Anticipated
Date of study closure: Date
01/04/2024
Recruitment status
Pending
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
N/A
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Lebanese American University Institutional Review Board
LAUMCRH.RC1.13/Oct/2023
Sources of Monetary or Material Support
Name
Pharma M SAL
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Omar
El Masri
Beirut
Lebanon
71354271
omar.elmasri@lau.edu
Lebanese American University
Scientific
Rajaa
Chatila
Beirut
Lebanon
03539849
rajaa.chatila@lau.edu.lb
Lebanese American University
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Lebanese American University Medical Center - Rizk Hospital
Dr. Rajaa Chatila
Gastroenterology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Lebanese American University- University Medical Center Rizk Hospital
13/10/2023
LAU IRB
irb@lau.edu.lb
01786464
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Gastroesophageal Reflux Disease
Gastro-oesophageal reflux disease (K21)
GERD
Interventions
Intervention
Description
Keyword
Probiotic
Multi-strain probiotic, that contains Lactobacillus rhamnosus GG, Saccharomyces boulardii, Bifidobacterium breve, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus reuteri, prebiotics, and zinc (from citrate) (Probiolife®) .
Probiotic
Primary Outcomes
Name
Time points
Measure
Gastroesophageal Reflux Disease Symptoms
8 weeks
The Gastroesophageal Reflux Disease-Health Related Quality of Life instrument
Key Secondary Outcomes
Name
Time points
Measure
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial