Evaluating the effects of adding the probiotic Balance® compared with placebo to quadruple therapy on eradication of helicobacter pylori and symptoms of patients with peptic ulcer disease referring to gastroenterology clinics in Isfahan
The aim of this study was to determine the effects of adding the probiotic Balance® to the quadruple therapy on eradication of helicobacter pylori and improvement of clinical symptoms in patients with peptic ulcer, referring to gastroenterology clinics of Isfahan. One hundred eighty adult patients with upper gastrointestinal symptoms (dyspepsia) referred to gastroenterologist that had endoscopic confirmed ulcers and helicobacter pylori infection by rapid urease test, and not having severe systemic disease or history of gastrointestinal surgery were included into the study. Patients were randomized into two groups (90 cases in each group) of Balance® and placebo. For all patients, quadruple therapy regimen (Omeprazole 20 mg twice daily, Bismuth subcitrate 240 mg twice daily, Amoxicillin 1 gr twice daily, and Clarithromycin 500 mg twice daily) were administered for 14 days. Patients in the Balance group received Balance® capsules twice daily (after dinner and lunch) for 14 days. In the placebo group, patients received placebo capsules the same as Balance® capsule. The main outcome was the helicobacter pylori eradication after 4 weeks and secondary outcome measures were dyspepsia symptoms assessed by the Lead Dyspepsia Questionnaire at baseline, end of treatment (day 15), and at the time of the evaluation of eradication (4 weeks after completion of therapy).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209041579N4
Registration date:2012-10-03, 1391/07/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-03, 1391/07/12
Registrant information
Name
Ali Gholamrezaei
Name of organization / entity
Medical Students' Research Center, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1669 8675
Email address
gholamrezaei@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of adding the probiotic Balance® compared with placebo to quadruple therapy on eradication of helicobacter pylori and symptoms of patients with peptic ulcer disease referring to gastroenterology clinics in Isfahan
Public title
Probiotic for eradication of helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Age 18 to 65 years,
- Having peptic ulcer disease on upper gastrointestinal endoscopy,
- Having helicobacter pylori infection diagnosed by rapid urease test or urea breath test,
- Willingness to participate in the study,
- Not having Zollinger Ellison Syndrome, cancers of the digestive tract, liver or kidney diseases, other infections may require antibiotics, immune deficiency disease,
- No history of upper gastrointestinal surgery,
- No history of the eradication of Helicobacter pylori, or the use of Proton Pomp Inhibitors, antibiotics, and probiotics (synthetic or natural) over the past 4 weeks,
- No contraindications for using any dug of the quadruple therapy.
Exclusion criteria:
- Not taking medications regularly, (not taking >= 20% of all the prescribed capsules),
- Severe side effects of the quadruple therapy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients were randomly assigned to two groups according to a table of random numbers created by the software. Placebo capsule was the same as Balance® capsule and both the physician and the patient were unaware about the treatment arms.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Postal code
Approval date
2011-07-10, 1390/04/19
Ethics committee reference number
390215
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified
Primary outcomes
1
Description
Helicobacter pylori eradication
Timepoint
Four weeks after treatment
Method of measurement
Urea breath test
Secondary outcomes
1
Description
Dyspepsia symptoms severity
Timepoint
At baseline, 15th day, and 4 weeks after treatment
Method of measurement
Lead Dyspepsia Questionnaire
Intervention groups
1
Description
Intervention group: - Quadruple therapy regimen for helicobacter pylori eradication including Omeprazole 20 mg (Sobhan Co., Tehran, Iran) twice daily, Bismuth subcitrate 240 mg (ChemieDarou Co., Tehran, Iran) twice daily, Amoxicillin 1 gr (Farabi Co., Tehran, Iran) twice daily, and Clarithromycin 500 mg (Loghman Co., Tehran, Iran) twice daily for 14 days. Plus - Capsules of Balance® (Protexin Co., Somerset, UK) twice daily for 14 days. Each capsule of Balance® contains: Lactobacillus casei PXN 37 Lactobacillus rhamnosus PXN 54 Streptococcus thermophilus PXN 66 Bifidobacterium breve PXN 25 Lactobacillus acidophilus PXN 35 Bifidobacterium longum PXN 30 Lactobacillus bulgaricus PXN 39. TVC per capsule: 100 million CFU
Category
Treatment - Drugs
2
Description
Control group:
- Quadruple therapy regimen for helicobacter pylori eradication including Omeprazole 20 mg (Sobhan Co., Tehran, Iran) twice daily, Bismuth subcitrate 240 mg (ChemieDarou Co., Tehran, Iran) twice daily, Amoxicillin 1 gr (Farabi Co., Tehran, Iran) twice daily, and Clarithromycin 500 mg (Loghman Co., Tehran, Iran) twice daily for 14 days.
Plus
- Capsules of placebo twice daily for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital Gastroenterology Clinics
Full name of responsible person
Dr. Elham Tabesh
Street address
Ferdosi Ave., Khorshid Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Elham Tabesh
Position
Physician, Resident of Internal Medicine
Other areas of specialty/work
Street address
Internal Medicine Group, Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 1792 2472
Fax
+98 31 1792 2472
Email
elham7979@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Shavakhi
Position
Associate Prof. Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Internal Medicine Group, Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Postal code
73461-81746
Phone
+98 31 1792 2472
Fax
+98 31 1792 2472
Email
shavakhi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Elham Tabesh
Position
Physician, Resident of Internal Medicine
Other areas of specialty/work
Street address
Internal Medicine Group, Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 1792 2472
Fax
+98 31 1792 2472
Email
elham7979@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)