Protocol summary
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Study aim
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The effect of probiotic yogurt consumption on Gastroesophageal reflux disease
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Design
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120 patients will participate in the study, in three groups: non-probiotic yogurt, probiotic yogurt and omeprazole group with 40 patients in each group.
Randomization will be based on Permuted Block Randomization
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Settings and conduct
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A clinical trial study (three-blinded for our cohorts), between 2020-21, on patients older than 18 years referred to Gastroenterology Clinics of North Khorasan with gastroesophageal reflux disease (Gastroenterology and Liver). Three treatment modalities (prebiotic yogurt, plain yogurt, omeprazole) are written on cardboards by codes and enclosed in envelopes and will be delivered to the specialist physician in a completely randomized manner.
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Participants/Inclusion and exclusion criteria
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-Inclusion criteria:
The patient be literate or someone helps him/her in filling the questionnaires;
Patients should be geographically accessible
-Exclusion criteria:
Age less than 18 years;
Allergy to dairy products;
Pregnancy;
History of gastrointestinal malignancy
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Intervention groups
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There are three treatment groups with three treatments. The first group will consume normal yogurt, the second group will take omoprazole, and the third group will use prebiotic yogurt.
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Main outcome variables
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evaluation of quality of life
Intensity of reflux
General information
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Reason for update
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Modifying the sample size and secondary outcome
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190831044653N4
Registration date:
2020-01-30, 1398/11/10
Registration timing:
registered_while_recruiting
Last update:
2023-03-29, 1402/01/09
Update count:
1
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Registration date
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2020-01-30, 1398/11/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-01, 1398/08/10
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Expected recruitment end date
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2020-05-30, 1399/03/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effects of yogurt containing probiotics in treating gastroesophageal reflux disease: a randomized clinical trial
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Public title
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Evaluating the effects of yogurt containing probiotics in treating gastroesophageal reflux disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The patient be literate or someone helps him/her in filling the questionnaires
Patients should be geographically accessible
Exclusion criteria:
Age less than 18 years
Allergy to dairy products
Pregnancy
History of gastrointestinal malignancy
History of gastric and esophageal surgery and small bowel bypass
Liver and kidney and heart dysfunction
Concomitant use of NSAIDs and aspirin for up to one week before the study
Anticancer or antibiotic use during 4 weeks before referral and participation in this study
No anti-acid, hydrogen pump inhibitors, H2 receptor inhibitors in two groups of yogurt recipients during the study
Receiving bisphosphenate, cortisone, potassium chloride or iron tablets concurrently in the study
Patient's compliance be less than 80% (self-reported by patient)
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, patients were randomized based on block permutation methods (permuted block randomization) into the three treatment groups (2 groups (probiotic yogurt and regular yogurt) and a control group).
Based on the result of randomization by Permuted Block Randomization and R software, patients are allocated to groups sequentially in order of their meeting.
The yogurts, both probiotic and simple, will be provided in the same shape single dose containers without any type definer and will be introduced to the drug distributor with unmeaning code.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-16, 1398/08/25
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Ethics committee reference number
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IR.NKUMS.REC.1398.084
Health conditions studied
1
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Description of health condition studied
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Gastroesophageal reflux disease (GERD)
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ICD-10 code
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K21
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ICD-10 code description
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Gastro-esophageal reflux disease
Primary outcomes
1
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Description
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effect on the GERD severity
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Timepoint
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Baseline, one month and tow months later
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Method of measurement
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The Gastroesophageal Reflux Disease-Health Related Quality of Life instrument (related to typical symptoms)
2
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Description
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Effect on the severity of GERD atypical symptoms
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Timepoint
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Baseline, one month and tow months late
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Method of measurement
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Reflux Symptom Index and Disease Specific Quality of Life Index questionnaires (related to atypical symptoms)
Secondary outcomes
1
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Description
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Assessment of quality of life
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Timepoint
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At baseline, one month and tow months later
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Method of measurement
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questionnaire
Intervention groups
1
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Description
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Intervention group: Ordinary yogurt
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Category
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Treatment - Other
2
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Description
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Intervention group: Probiotics yogurt
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Category
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Treatment - Other
3
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Description
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Control group: Omeprazole
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant, Faculty Member of Bojnourd University of Medical Sciences
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bojnourd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available