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Comparing the effects of Lactobacillus Reuteri and Standard treatment in treatment of infected children with Helicobacter pylori in Imam Ali Hospital in july2012 to November 2013.

Protocol summary

Summary
The aim of this study is evaluating the effects of Lactobacillus Reuteri in treatment of infected children with Helicobacter Pylori in Imam Ali Hospital Zahedan in July 2012 and November 2013 .Primary obetween utcomes include symptoms(abdominal pain,nausing,vomiting,diarrhea,constipation,heart burn,weight loss)that recorded in questionaier ;eradication;kind of treatment(1-Amoxicillin50mg/kg/day,Omeprazole1mg/kg/day,Clarythromycin15mg/kg/day.2-standard treatment and Lactobacillus Reuteri 1tab/12h) . The study is clinical Trial,double blind ,accidental. Inclusion criteria:5-14 years old children; Chronic abdominal pain ; vomiting ;positive Helicobacterpylori infection in Endoscopy that target sample size were 50 , Exclusion criteria:Patients with Antibiotic adminstration;and Proton Pomp Inhibitors or Probiotics in recent two weeks ;Gastric surgery history; Nurologic disease ; Life Threatening disorders. Patients were distributed in two groups.25 patients received Standard treatment three drugs for 14 days. and another group received Lactobacillus Rreuteri and three drugs Standard treatment for the same period, that have treated for 14days.and after 4-6 weeks performed UBT was performed in order to investigate eradication of Helicobacterpylori infection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071814048N1
Registration date: 2013-09-20, 1392/06/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-20, 1392/06/29
Registrant information
Name
Elham Shafighi shahri
Name of organization / entity
Zahedan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1242 2016
Email address
eshahri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Zahedan University Of Medical Sciences
Expected recruitment start date
2012-06-13, 1391/03/24
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Lactobacillus Reuteri and Standard treatment in treatment of infected children with Helicobacter pylori in Imam Ali Hospital in july2012 to November 2013.
Public title
Probiotic in treatment of Helicobacterpylory infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:5-14 years old children; Chronic abdominal pain ; vomiting ;positive Helicobacterpylori infection in Endoscopy . Exclusion criteria:Patients with Antibiotic adminstration;and Proton Pomp Inhibitors or Probiotics in recent two weeks ;Gastric surgery history; Nurologic disease ; Life Threatening disorders.
Age
From 5 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University Of Medical Sciences
Street address
Sistan and Baluchestan,Iran
City
Zahedan
Postal code
9816743463
Approval date
2012-06-12, 1391/03/23
Ethics committee reference number
91-560

Health conditions studied

1

Description of health condition studied
Helicobacterpylori infection
ICD-10 code
B98-0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Primary outcomes

1

Description
Vomiting
Timepoint
First and End of treatment
Method of measurement
Physical Exam and questioniear

2

Description
Constipation
Timepoint
First and End of treatment
Method of measurement
Physical Exam and questioniear

3

Description
Diarrhea
Timepoint
First and End of treatment
Method of measurement
Physical Exam and questioniear

4

Description
Nausing
Timepoint
First and End of treatment
Method of measurement
Physical Exam and questioniear

5

Description
Abdominal pain
Timepoint
First and End of treatment
Method of measurement
Physical Exam and questioniear

6

Description
Heart burn
Timepoint
First and End of treatment
Method of measurement
Physical Exam and questioniear

7

Description
Weight loss
Timepoint
First and End of treatment
Method of measurement
Physical Exam and questioniear

Secondary outcomes

1

Description
Anemia
Timepoint
First and End Of Treatment
Method of measurement
CBC

Intervention groups

1

Description
drugs in group that received standard treatment includes Amoxicillin50mg/kg/day,Omeprazole1mg/kg/day,Clarythromycin15mg/kg/day for 14 days.
Category
Treatment - Drugs

2

Description
drugs in group that received standard treatment and Lactobacillus Reuterri includes Amoxicillin50mg/kg/day,Omeprazole1mg/kg/day,Clarythromycin15mg/kg/day, Lactobacillus Reuterri 1tab/12h for 14 days .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endoscopy Of Emam Ali Hospital
Full name of responsible person
Elham Shafighi Shahri
Street address
Emam Ali Hospital,Zahedan
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for research
Full name of responsible person
Dr Hamidreza Mahmoodzade Sagheb
Street address
Zahedanl University Of Medical Sciences
City
Zahedan
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
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
Zahedan University Of Medical Sciences
Full name of responsible person
Elham Shafighi Shahri
Position
Pediatric Resident
Other areas of specialty/work
Street address
Daneshgah Ave.1,Zahedan
City
Zahedan
Postal code
9816867393
Phone
+98 54 1242 2016
Fax
Email
Eshahri@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University Of Medical Sciences
Full name of responsible person
Elham Shafighi Shahri
Position
Pediatric Resident.
Other areas of specialty/work
Street address
Daneshgah Ave.1,Zahedan
City
Zahedan
Postal code
9816867393
Phone
+98 54 1242 2016
Fax
Email
Eshahri@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University Of Medical Sciences
Full name of responsible person
Elham shafighi shahri
Position
Pediatric Resident
Other areas of specialty/work
Street address
Emam Ali Hospital, Zahedan
City
Zahedan
Postal code
9816867393
Phone
+98 54 1242 2016
Fax
Email
Eshahri@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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