History
# Registration date Revision Id
2 2020-03-11, 1398/12/21 129644
1 2018-01-28, 1396/11/08 34885
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Evaluation of the effects of concurrent Omega-3 and Cranberry juice consumption on eradication of Helicobacter pylori, gastrointestinal symptoms, some serum inflammatory and oxidative stress markers in adults with Helicobacter pylori infection
Design
Among patients referred to the liver and gastroenterologist, 92 patients with gastrointestinal complaints and inclusion criteria will be included in the study. Then, individuals will be allocated into one of the three intervention groups or the control group using a randomized blocked division (4 block based on BMI and gender).
Settings and conduct
The present study will be performed on adults referred to the liver and gastroenterologist of Soroush Clinic in Ahvaz in 1396.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having age between18 to 65 years old, infection with Helicobacter pylori, gastrointestinal complaints and body mass index of 18.5 to 35 kg / h. Exclusion criteria: Having a history of drug therapy to eradicate Helicobacter pylori infection, stomach surgery, history of peptic ulcer and gastrointestinal malignancies, having any disease that causes inflammation and increases levels of inflammatory markers, such as diabetes, cardiovascular disease, respiratory infections such as asthma. .., having immunodeficiency diseases, having chronic diseases requiring drug treatment, taking medications other than prescription drugs during the study, taking antibiotics or proton pump inhibitors or H2 blockers over the past 2 months, taking omega-3 supplementation at least 3 months before starting the study, using of any dietary supplement at least 3 months before starting the study, changes in the diet during the study period and the consumption of less than 80% of the supplements delivered to the patient during the study period.
Intervention groups
Interventional group 1: Two weeks taking of three treatments of Helicobacter pylori including: Pentoprazole 40 mg twice daily, Amoxicillin 1 g twice daily, Bismuth 2 mg 4 times daily, Clarithromycin 500 mg twice daily for two weeks+ Cranberry juice (400 ml) enriched with omega-3 (2 g) for 4 weeks. Intervention group 2: Two weeks taking of three treatments of Helicobacter pylori including: Pentoprazole 40 mg twice daily, Amoxicillin 1 g twice daily, Bismuth 2 mg 4 times daily, Clarithromycin 500 mg twice daily + Cranberry juice (400 ml) for 4 weeks Intervention group 3:Two weeks taking of three treatments of Helicobacter pylori including: Pentoprazole 40 mg twice daily, Amoxicillin 1 g twice daily, Bismuth 2 mg 4 times daily, Clarithromycin 500 mg twice daily for two weeks+ Omega- 3 (two grams) for 4 weeks Control group: Two weeks taking of three treatments of Helicobacter pylori including: Pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, bismuth 2 mg 4 times daily, and clarithromycin 500 mg twice daily for two weeks.
Main outcome variables
Primary outcome variable: Negative anti-Helicobacter pylori antigen; Determination and comparison of Helicobacter pylori caused gastrointestinal complaints questionnaire scale; serum levels of interleukin-17, TGFβ1 and INF-γ ; Serum levels of TAC and MDA

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151128025274N3
Registration date: 2018-01-28, 1396/11/08
Registration timing: prospective

Last update: 2018-01-28, 1396/11/08
Update count: 1
Registration date
2018-01-28, 1396/11/08
Registrant information
Name
Ahmad Zare Javid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8319
Email address
zarejavid-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-29, 1396/11/09
Expected recruitment end date
2018-07-20, 1397/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of concurrent Omega-3 and Cranberry juice consumption on eradication of Helicobacter pylori, gastrointestinal symptoms, some serum inflammatory and oxidative stress markers in adults with Helicobacter pylori infection
Public title
Effects of concurrent Omega-3 and Cranberry juice consumption on eradication of Helicobacter pylori, gastrointestinal symptoms, some serum inflammatory and oxidative stress markers in adults with Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years old Helicobacter pylori infection Gastrointestinal complaints Body mass index 18.5 to 35 kg / m2
Exclusion criteria:
Having a history of drug therapy to eradicate Helicobacter pylori infection Stomach surgery History of peptic ulcer and gastrointestinal malignancies Having any disease that causes inflammation and increased levels of inflammatory markers, such as diabetes, cardiovascular disease, respiratory infections such as asthma and ... Getting immunodeficiency diseases Developing chronic diseases requiring drug treatment Taking medications other than prescription drugs Receiving antibiotics or proton pump inhibitors or H2 blockers over the past 2 months Taking omega supplementation At least 3 months before the start of the study Use of any diet supplements During the study 3 months before the start of the study Changes in the diet during the study period Consumption of less than 80% of the supplements delivered to the patient during the study period.
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: 92
Randomization (investigator's opinion)
Randomized
Randomization description
By using randomized blocked categorization (4 block based on BMI and sex), individuals will be placed in one of the three intervention groups or in the control group.
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
Ethics committee of Jundishapur University of Medical Sciences
Street address
Golestan Highway, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715751
Approval date
2018-01-05, 1396/10/15
Ethics committee reference number
IR.AJUMS.REC.1396.819

Health conditions studied

1

Description of health condition studied
Helicobacter pylori
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
Negative cases of Helicobacter pylori infection
Timepoint
Three weeks after the end of treatment
Method of measurement
Checking of H.Pylori stool antigen

2

Description
Scale of gastrointestinal complaints questionnaire from Helicobacter pylori infection
Timepoint
Before and at the end of the study
Method of measurement
Questionnaire

3

Description
Serum levels of Il-17, TGFβ1 and INF-γ
Timepoint
Before and at the end of the study
Method of measurement
ELISA method

4

Description
Serum levels of TAC and MDA
Timepoint
Before and after study
Method of measurement
ELISA method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Two weeks of helicobacter pylori triple therapy, including pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, bismuth 2 mg 4 times a day, and clarithromycin 500 mg twice daily + cranberry juice (400 ml) ) Enriched with omega-3 (two grams)
Category
Treatment - Other

2

Description
Intervention group: Two weeks of helicobacter pylori triple therapy, including pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, bismuth 2 mg 4 times a day, and clarithromycin 500 mg twice daily + cranberry juice (400 ml) )
Category
Treatment - Other

3

Description
Intervention group: Two weeks of helicobacter pylori triple therapy, including pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, bismuth 2 mg 4 times a day, and clarithromycin 500 mg twice daily + omega-3 (two grams)
Category
Treatment - Other

4

Description
Control group: Two weeks of helicobacter pylori triple therapy, including pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, bismuth 2 mg 4 times a day, and clarithromycin 500 mg twice daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Soroush Clinic
Full name of responsible person
Dr. Pezhman alavinezhad
Street address
Kianpars st., Western Vahabi st., Soroush st.
City
Ahvaz
Province
Khouzestan
Postal code
6135715751
Phone
+98 61 1373 8330
Email
ahmaddjavid@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Golestan Highway;Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
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

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Maghsoumi-Nourozabad
Position
Nutrition PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Highway, faculty of paramedicine, Department of nutrition, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715751
Phone
+98 61 3373 8330
Email
l.maghsumi55@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Zare Javid
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway, Faculty of Paramedicine, Department of Nutrition,Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715751
Phone
+98 61 3373 8330
Email
ahmaddjavid@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Maghsoumi-Nourozabad
Position
Nutrition PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Highway, faculty of paramedicine, Department of nutrition, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715751
Phone
+98 61 3373 8330
Email
l.maghsumi55@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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