Comparing effect of addition of apple cider vinegar to triple regimen with pantaprazole, clarithromycin and amoxicillin on Helicobacter pylori eradication.
The purpose of this study was to evaluate the effect of apple cider vinegar plus Proton Pump Inhibitor based triple therapy on eradication of Helicobacter pylori.
116 patients with H. pylori infection were studied. Patients in study group (59 patients) received amoxicillin, clarithromycin, and pantaprazole twice daily. Patients in control group (57 patients) received the same regimen plus 30 mL of apple cider vinegar twice daily. The duration of therapy for study and control groups was 10 and 14 days respectively. Four weeks after the completion of therapy, Urea breath test was performed to assess the success of H. pylori infection eradication.
General information
Acronym
Helicobacter Pylori and apple cider vinegar
IRCT registration information
IRCT registration number:IRCT2013100614901N1
Registration date:2013-10-21, 1392/07/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-21, 1392/07/29
Registrant information
Name
Zahra Vahdat Shariatpanahi
Name of organization / entity
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7484
Email address
z.shariatpanahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Science
Expected recruitment start date
2012-08-12, 1391/05/22
Expected recruitment end date
2013-09-01, 1392/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of addition of apple cider vinegar to triple regimen with pantaprazole, clarithromycin and amoxicillin on Helicobacter pylori eradication.
Public title
Effect of apple cider vinegar on Helicobacter pylori growth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Positive rapid urease test patients without ulcer; Without consumption of H2 antagonists, proton pump inhibitors and antibiotics in four recent weeks. Without gastrointestinal bleeding in recent four weeks
Exclusion criteria: Who can not tolerance apple cider vinegar
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
liam University of Medical Sciences
Street address
Banghanjab street, Ilam, Iran
City
Ilam
Postal code
Approval date
2013-10-07, 1392/07/15
Ethics committee reference number
EC/92/h/147
Health conditions studied
1
Description of health condition studied
Contamination of stomach with h.pylori
ICD-10 code
k31.9
ICD-10 code description
Disease of stomach and duodenum, unspecified
Primary outcomes
1
Description
H.pylori growth
Timepoint
Before treatment
Method of measurement
Rapid Urease Test
Secondary outcomes
1
Description
Growth of H.Pylori
Timepoint
4 weeks after completion of treatment
Method of measurement
Breath Urease Test
Intervention groups
1
Description
The study group received 40 mg pantaprazol, 1 g amoxicillin, and 500 mg clarithromycin twice daily plus 30 mL of raw, unfiltered ACV in a glass of water twice daily after meal over 10 days.
Category
Treatment - Other
2
Description
The control group received 40 mg pantaprazol, 1 g amoxicillin, and 500 mg clarithromycin twice daily over two weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali hospital
Full name of responsible person
Street address
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Farid Jalilian
Street address
Banganjab St, Ilam
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi
Position
MD, PhD in nutrition
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
City
Tehran
Postal code
Phone
+98 21 2235 7484
Fax
Email
nutritiondata@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi
Position
MD. PhD
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
City
Tehran
Postal code
Phone
+98 21 2235 7484
Fax
Email
nutritiondata@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Vahdat Shariatpanahi,
Position
Assistant Prof.
Other areas of specialty/work
Street address
3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods,Tehran, I.R. Iran
City
Tehran
Postal code
Phone
+98 21 2235 7484
Fax
Email
nutritiondata@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)