Comparison between therapy regimen of amoxicillin,omeperazole,metronidazole and therapy regimen of amoxicillin,omeperazole,metronidazole and kidilact for treatment of helicobacter pylori infection in children 5 to 18 years in Imam Ali clinic of Shahrekord
The goal of this study is to compare the efficacy of amoxicillin, omeperazole, metronidazole with amoxicillin, omeperazole, metronidazole and Kidilact on the eradication of helicobacter pylori in children 5 to 18 years old.
Inclusion criteria: patients under 18 who have undergone endoscopy because of gastrointestinal problems; Patients having gastrointestinal problems who have written consent for inclusion after receiving a full explanation of the study.
Exclusion criteria: allergy to any of the drugs used; drug side effect such as vomiting or severe abdominal pain; previous H-pylori eradication therapy; recent use of probiotics, antibiotics or anti acids.
The study population is selected of children 5 to 18 that are referred to Imam Ali clinic of Shahrekord due to gastrointestinal disorders. The total sample size is 132.
Case group intervention in this study is standard triple therapy that includes amoxicillin 25 milligram per kilogram, two times a day ( maximum 1 gram) ; metronidazole 15 to 20 milligram per kilogram , two times a day; omeprazole 1 milligram per kilogram twice a day . And a sachet of kidilact once a day.( each sachet contains 109 CFU probiotics) this treatment is given for two weeks. Omeperazole is given for 4 weeks. The intervention in control group is standard triple therapy without kidilact. estimated time of the study is 10 months. The primary outcome of study is to achieve a more effective therapy for eradication of helicobacter pylori that has lesser complication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051433965N1
Registration date:2017-07-05, 1396/04/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-05, 1396/04/14
Registrant information
Name
Niloofar Kasiri
Name of organization / entity
Zahedan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
n.kasiri@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between therapy regimen of amoxicillin,omeperazole,metronidazole and therapy regimen of amoxicillin,omeperazole,metronidazole and kidilact for treatment of helicobacter pylori infection in children 5 to 18 years in Imam Ali clinic of Shahrekord
Public title
kidilact effect on stomach infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients younger than 18 years old that are referred to Imam Ali clinic of Shahrekord because of gastrointestinal problems and have under gone endoscopy and Helicobacter Pylori is approved with rapid urease test, pathology or stool antigen ; Patients having gastrointestinal problems who have written consent for inclusion after receiving a full explanation of the treatment, drugs used, duration of treatment and possible side effects
Exclusion criteria: Patients who have allergy to any of the medications amoxicillin, omeprazole, metronidazole, kidilact ; Patients who experience complications such as severe or unbearable pain ,severe vomiting during study ; Patients who want to leave the study for any reason during the study; patients who previously were treated with Helicobacter pylori eradication regimen; The recent use of probiotics, antibiotics, anti-acid
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
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 Science
Street address
Zahedan University of Medical Science, Doctor hesabi square, Zahedan
City
Zahedan
Postal code
Approval date
2017-03-07, 1395/12/17
Ethics committee reference number
IR.ZAUMS.REC.1395.105
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection of stomach
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
Helicobacter pylori eradication rate
Timepoint
2 weeks after end of treatment
Method of measurement
Stool antigen Test
Secondary outcomes
1
Description
Therapy side effects rate
Timepoint
Day 14 of treatment, 2 weeks after completion of antibiotic therapy and 4 to 6 weeks after completion of antibiotic therapy
Method of measurement
Check list that is completed by parents include diarrhea, constipation, nausea, vomiting, abdominal pain, heartburn, early satiety, decreased appetite, belching, metallic taste in mouth, halitosis and hives
Intervention groups
1
Description
Therapy regimen of amoxicillin,omeperazole,metronidazole in control group
Category
Treatment - Drugs
2
Description
Therapy regimen of amoxicillin,omeperazole,metronidazole and kidilact in intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali clinic of Shahrekor
Full name of responsible person
Doctor Karam ali Kasiri
Street address
Basij square, Imam Ali clinic of Shahrekor
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Doctor Hooshang Rafighdoost
Street address
Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Shahrekord University of Medical Sciences
Full name of responsible person
Doctor Karam Ali Kasiri
Position
Pediatric Gastroenterologist
Other areas of specialty/work
Street address
Hajar Hospital of Shahrekord, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3334 3701
Fax
Email
kasiri2007@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
Doctor Manijeh Khalili
Position
Pediatric Gastroenterologist
Other areas of specialty/work
Street address
Zahedan, Doctor Hesabi square, Zahedan University of Medical Sciences
City
Zahedan
Postal code
Phone
+98 54 3329 5715
Fax
Email
dr_khalil2000@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
Niloofar Kasiri
Position
medical student
Other areas of specialty/work
Street address
Alley number 7, 17 Shahrivar street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3334 3701
Fax
Email
niloofar.kasiri2000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)