Protocol summary

Study aim
Evaluate the effect of adding probiotic Saccharomyces Boulardi (DAILY EAST) or DSMZ 17648 Lactobacillus Reuteri strain supplement (PYLOSHOT), to the four-drug standard treatment after 14 days for H.Pylori infection, on increasing the elimination rate and reducing side effects.
Design
Of the patients with complete consent and inclusion criteria, 156 patients were selected as available. Then, using the oblique coin, patients are randomly assigned to treatment groups of 52 people. The clinical trial has a control group, with parallel groups, double-blind and randomized.
Settings and conduct
The study site is the specialty gastrointestinal clinic of Valiasr hospital in Birjand. The 156 patients were randomly divided into 52 groups (one control group and two case groups). The control group received placebo for 14 days with a routine anti-Helicobacter pylori quadruple regimen. Case groups are treated with DAILYEAST® or PHYLOSHOT supplement for 14 days.
Participants/Inclusion and exclusion criteria
Symptomatic H. pylori-positive individuals, confirmed by clinical, endoscopic, and pathological reports, are the inclusion criteria. Under 15 years of age, history of any concomitant serious illness, immunosuppressive drug use, antibiotic use in the past 3 months, and proton pump inhibitors, bismuth salts, or probiotics over the past 4 weeks, history of gastric surgery, clear weight loss, Previous history of Helicobacter pylori eradication, alcohol or drug abuse, and concurrent clinical trials are all excluded.
Intervention groups
Probiotics generally have potential beneficial effects in the treatment and prevention of various gastrointestinal diseases. Saccharomyces Bullardi (DAILYEAST® supplement) and DSMZ 17648 Lactobacillus Reuteri (PYLOSHOT supplement) are the most common probiotics used in clinical trials.
Main outcome variables
Stool Antigen test; Recovery time; Treatment complications.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200106046021N1
Registration date: 2020-01-14, 1398/10/24
Registration timing: registered_while_recruiting

Last update: 2020-01-14, 1398/10/24
Update count: 0
Registration date
2020-01-14, 1398/10/24
Registrant information
Name
Nushin Naghibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3162 2035
Email address
nushin_naghibzadeh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-08, 1398/10/18
Expected recruitment end date
2020-07-08, 1399/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Quadruple Therapy with Saccharomyces Boulardii or a Lactobacillus Reuteri Strain DSMZ 17648 Supplement (PYLOSHOT®) on Eradication of Helicobacter Pylori and Treatment Side Effects: a Double-Blind Placebo-Controlled Randomized Clinical Trial
Public title
The effect of Quadruple Therapy with Saccharomyces Boulardii or a Lactobacillus Reuteri Strain DSMZ 17648 Supplement (PYLOSHOT®) on Eradication of Helicobacter Pylori and Treatment Side Effects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Symptoms of H. pylori-positive as Confirmed by Clinical, Endoscopic, and Pathological Reports.
Exclusion criteria:
Pregnancy and lactation Patients with Liver, CardioPulmonary, Renal, Neoplastic Diseases People taking Proton Pump Inhibitors, Bismuth Salts, or Probiotics for the past 4 weeks and any Immuno Suppressive Drugs Surgery such as Gastrectomy or Gastric Bypass The existence of Autoimmune Diseases IBD (Inflammatory Bowel Disease) Organ Transplant Weight loss over 3kg over the past three months Previous History of Helicobacter Pylori Eradication Oral Antibiotic use in less than 3 months Alcohol abuse Participate in Other Clinical Trials Concurrently
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 156
More than 1 sample in each individual
Number of samples in each individual: 2
Helicobacter Pylor Stool Antigen Testing will be Performed for Patients 2 and 6 weeks after treatment.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected as Available and then Randomly Assigned to Treatment Groups using the Oblique Coin.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, All Participants, Physicians Responsible for Treating Patients, the Principal Investigator, and the Collectors of Patient information and data on outcome variables, Blinding be.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Second floor, Valiasr Hospital, Ghaffari Ave., Department of Education
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.BUMS.REC.1398.305

Health conditions studied

1

Description of health condition studied
Gastric infection with Helicobacter pylori
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mean recovery time in study groups
Timepoint
2 and 6 weeks after the end of treatment
Method of measurement
Stool Antigen Test

2

Description
Frequency distribution of treatment side effects in study groups
Timepoint
During treatment weekly
Method of measurement
Using the questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Taking placebo capsules that are completely identical to supplements in weight, size, shape and taste for 14 days in combination with the standard four-dose regimen for Helicobacter pylori infection for 14 days. The dosage is one after breakfast and one after dinner.
Category
Placebo

2

Description
First Intervention group: They take supplemental Saccharomyces Bullardi (DAILYEAST®) for 14 days in combination with the usual four-dose regimen for Helicobacter pylori infection, one after breakfast and one after dinner.
Category
Treatment - Drugs

3

Description
Second Intervention group: Supplement DSMZ 17648 Lactobacillus Reuteri (PYLOSHOT) strain for 14 days in combination with routine quadruple therapy for Helicobacter pylori infection, two after breakfast and two after dinner.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Nushin Naghibzadeh
Street address
Ghaffari Street, Valiasr Hospital
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3162 2035
Email
public_r@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Birjand University of Medical Sciences
Street address
Ghafari Street, Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
public_r@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
ZIST TAKHMIR Pharmaceutical company
Full name of responsible person
Dr. Mojgan Velayati
Street address
Resalat Square, Farjam Street, Heidarkhani intersection, No. 597
City
Tehran
Province
Tehran
Postal code
1683848411
Phone
+98 21 7749 5007
Email
info@bonyankasra.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ZIST TAKHMIR Pharmaceutical company
Proportion provided by this source
60
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nushin Naghibzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Second Floor,Valiasr Hospital,Ghaffari Ave.,Department of Education
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3162 2035
Fax
Email
nushin_naghibzadeh@bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr.Tahmine Tavakoli
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterologist
Street address
Ghaffari Street, Valiasr Hospital
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3162 2035
Email
tahminetavakoli95238@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nushin Naghibzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Second Floor,Valiasr Hospital,Ghaffari Ave.,Department of Education
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3162 2035
Fax
Email
nushin_naghibzadeh@bums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Age data of the participants, symptoms that led to the gastrointestinal clinic, the reason for the endoscopy, and the outcome after the end of the study were shared. Participants are unrecognizable.
When the data will become available and for how long
Start access period immediately after printing results.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
If relevant, study compares the treatment regimens of Helicobacter pylori infection and the use of probiotics in treatment.
From where data/document is obtainable
Send mail to Dr. Tahmineh Tavakoli as a Clinical Trial Examiner. Birjand University of Medical Sciences. tahminetavakoli95238@yahoo.com
What processes are involved for a request to access data/document
Email and send request
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