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Evaluation the effect of probiotics on gastrointestinal symptoms in patients with gastric cancer

Protocol summary

Study aim
Determining the effect of probiotics on gastrointestinal symptoms in patients with gastric cancer
Design
Clinical trial with control group, with parallel groups, randomized
Settings and conduct
Sixty patients referred to the gastrointestinal clinic of the teaching hospitals of the Islamic Azad University of Mashhad, based on inclusion criteria, will be randomly assigned (blocking) to the intervention or control group without the knowledge in which group they are in. VAS visual scale for Gastrointestinal symptoms such as abdominal pain, diarrhea, constipation and bloating will complted for both group before and two months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 to 70 years, Endoscopically confirmed gastric cancer and pathology that are in the recovery phase (their treatment is over), Refer to the gastroenterology clinic of Azad University of Mashhad Educational hospitals, Informed consent to enter the study. Exclusion criteria: Obvious neurological disease, Probiotic consumption in the past month, Dissatisfaction with inclusion in the study, Lack of cooperation, Lack of proper use of the Probiotic in both groups, Sensitivity to the studied Probiotic, Pregnant or lactating women, Chronic users of non-steroidal anti-inflammatory drugs.
Intervention groups
In the intervention group, probiotic capsules containing three strains of probiotic bacteria including Lactobacillus acidophilus, Bifidobacterium lactis and Bifidobacterium longum will be given to them and it is recommended to take one capsule daily in the first two weeks. In the control group, participants will receive capsules containing maltodextrin prepared in both color and shape of the product capsules.
Main outcome variables
VAS visual scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211226053534N1
Registration date: 2022-02-19, 1400/11/30
Registration timing: prospective

Last update: 2022-02-19, 1400/11/30
Update count: 0
Registration date
2022-02-19, 1400/11/30
Registrant information
Name
Elham Mokhtari Amirmajdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 316 5096
Email address
emokhtaria@mshdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of probiotics on gastrointestinal symptoms in patients with gastric cancer
Public title
Evaluation the effect of probiotics on gastrointestinal symptoms in patients with gastric cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 70 years Endoscopically confirmed gastric cancer and pathology that are in the recovery phase (their treatment is over) Refer to the gastroenterology clinic of Azad University of mashhad educational hospitals Informed consent to enter the study
Exclusion criteria:
Obvious neurological disease Probiotic consumption in the past month Dissatisfaction with inclusion in the study Lack of patient cooperation Lack of proper use of the Probiotic in both groups Sensitivity to the studied Probiotic Pregnant or lactating women Chronic users of non-steroidal anti-inflammatory drugs
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this way, the allocation of samples to test or control groups will be done by random allocation (using blocking). The use of blocking will be done on different days due to the allocation of samples. In this method, the groups are first identified by giving the code to the groups that will be group A: intervention and B: control. 5 blocks of 6 are specified: 1- AABBAB, 2- BBAABA, 3-AABABB, 4-BABABA, 5-BBBAAA, 6- AAABBB. Finally, they are included in the study and placed in the intervention and control groups, respectively. After completing the first 5 blocks, the second block will be sampled.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not be informed about which group they will be in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University - Mashhad Branch (Research Ethics Committee)
Street address
Islamic Azad University School of Medicine,Imam khomeini14 Aven, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.IAU.MSHD.REC.1400.048

Health conditions studied

1

Description of health condition studied
Gasteric cancer
ICD-10 code
C16.9
ICD-10 code description
Malignant neoplasm of stomach, unspecified

Primary outcomes

1

Description
VAS visual scale for Gastrointestinal symptoms such as abdominal pain, diarrhea, constipation and bloating
Timepoint
Before the intervention and at the end of the fourth and eighth weeks
Method of measurement
VAS visual scale

2

Description
Timepoint
Method of measurement

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Probiotic capsule containing three strains of probiotic bacteria including Lactobacillus acidophilus, Bifidobacterium lactis and Bifidobacterium longum and is one the products of Gostaresh Milad Pharmed Company will be provided to them and it is recommended that they take one capsule a day in the first two weeks.
Category
Treatment - Drugs

2

Description
Control group: participants will receive capsules containing maltodextrin prepared in both color and shape of the product capsules.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Dr. Elham Mokhtari Amir Majdi
Street address
BaBa Nazr 39, Kuy-e-Tollab
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 51 3259 4344
Email
Emokhtaria@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Aria Hospital
Full name of responsible person
Dr. Elham Mokhtari Amir Majdi
Street address
Golestan sharghi Ave, Chamran St
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 51 3259 4344
Email
Emokhtaria@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Toraj zandbaf
Street address
School of Medicine,Imam khomeini14 Aven, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 51 3225 0041
Email
tooraj.zandbaf@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Elham Mokhtari Amirmajdi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
School of Medicine,Imam khomeini14 Aven, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 915 316 5096
Fax
Email
Emokhtaria@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Mokhtari Amirmajdi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
School of Medicine,Imam khomeini14 Aven, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 915 316 5096
Fax
Email
Emokhtaria@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shima sadat hosseini nejad
Position
Medical Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine,Imam khomeini14 Aven, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9178673799
Phone
+98 915 316 5096
Fax
Email
hoseininsh@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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