Determining the therapeutic effect of Probiotics together with Metronidazole and Probiotics alone in patients with functional flatulence
Design
The clinical trial has 2 intervention groups, with parallel groups, double-blind, randomized by table of random numbers. After randomization, patients are divided into 2 groups of 45 people and receive the drugs.
Settings and conduct
The present study will be performed as a clinical intervention in the gastrointestinal clinic of Khorshid Hospital in Isfahan. Patients will be randomized and divided into 2 groups. Patients, and evaluators will not know about the groups and received medications . Patients will be treated according to their group for 8 weeks. Patients' symptoms are measured by the bloating intensity questionnaire as well as the IBS-QOL questionnaire.
Participants/Inclusion and exclusion criteria
Including critera:
Age between 20 and 50 years; Having functional abdominal distention according to the Rome III criteria; The first experience of bloating is more than 6 months before the study; Abdominal bloating feeling at least 3 days a month in the last 3 months; Consent to participate in the study
Excluding criteria:
Any history of chronic inflammatory disease or structural disease of the gastrointestinal tract; Any serious physical problem or disease; Abnormal laboratory data; Severe stress in the last 6 months
Intervention groups
Intervention group 1: At first, for 2 weeks, they will receive 500 mg Metronidazole Tablet of Pars Daru three times a day, and after 2 weeks, they will receive 500 mg FamiLact Probiotic Tablet of Zisttakhmir Company, every 12 hours after the main meals for one month.
Intervention group 2: They will receive 500 mg FamiLact Probiotic Tablet of Zisttakhmir Company, every 12 hours after the main meals for one month.
Main outcome variables
Abdominal bloating
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220916055971N1
Registration date:2023-03-22, 1402/01/02
Registration timing:prospective
Last update:2023-03-22, 1402/01/02
Update count:0
Registration date
2023-03-22, 1402/01/02
Registrant information
Name
Mojtaba Mohammadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 515 9596
Email address
dr.mojtabamhmmdpr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the therapeutic effect of Probiotics along with Metronidazole and Probiotics alone in patients with functional flatulence
Public title
Metronidazole and Probiotics in functional flatulence patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 50 years
Having functional abdominal distention according to the Rome III criteria
The first experience of bloating is more than 6 months before the study
Abdominal bloating feeling at least 3 days a month in the last 3 months
Consent to participate in the study
Exclusion criteria:
Any history of chronic inflammatory disease or structural disease of the gastrointestinal tract
Any serious physical problem or disease such as inflammation or malignancy
َAbnormal laboratory data
Use of Calcium Channel Blocker drugs in the last 3 months
Severe stress in the last 6 months
Positive family history for colon cancer
Pregnancy or breastfeeding\
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (for example, top or bottom) and the researcher's second default is to consider numbers 0-45 for group 1, numbers 46-90 for group 2. The researcher then touches one of the numbers and moves in a predetermined direction, recording the numbers and assigning them to the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients will be assigned to 2 groups. Patients are not relieved of the drug content they receive because the appearance of all medications is the same. Clinical caregivers who give medications to patients also did not know what medication to give.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research, School of Medicine, Isfahan University of Medical Sciences
Street address
Al-Zahra Medical Education Center, Sofe Ave ,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2022-09-27, 1401/07/05
Ethics committee reference number
IR.MUI.MED.REC.1401.240
Health conditions studied
1
Description of health condition studied
Abdominal Bloating
ICD-10 code
R14.3
ICD-10 code description
Flatulence
Primary outcomes
1
Description
Abdominal Bloadting
Timepoint
Before the start of the study, 2 weeks after the start of the study, 4 weeks after the start of the study, 6 weeks after the start of the study and 8 weeks after the start of the study.
Method of measurement
Questionnaire for bloating and IBS-QOL questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: At first, for 2 weeks, they will receive 500 mg Metronidazole Tablet of Pars Daru three times a day, and after 2 weeks, they will receive 500 mg FamiLact Probiotic Tablet of Zisttakhmir Company, every 12 hours after the main meals for one month.
Category
Treatment - Drugs
2
Description
Intervention group 2: Probiotic recipient. Patients on this group receive Familact probiotic tablets from the Zist-takhmir company, containing 7 strains of bacteria (lactobacilli, bifidobacteria, streptococcus thermophilus), will receive every 12 hours after the main meal, and the duration of treatment will be 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorsheid hospital
Full name of responsible person
Maryam Sohilipour
Street address
Korshied hospital, Ostandari Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir
Web page address
https://nour.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Vice chancellor for research, Isfahan University of Medical Sciences; Faculty of Medicine; Isfahan University of Medical Sciences; Hezar-Jarib Street; Isfahan; Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam Soheilipour
Position
Assistant Professor of Gastroenterology and Hepatology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Al-Zahra Medical Education Center, Sofe Ave ,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0983136201991
Email
maryamsoheilip@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam Soheilipour
Position
Assistant Professor of Gastroenterology and Hepatology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Al-Zahra Medical Education Center, Sofe Ave ,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0983136201991
Email
maryamsoheilip@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam Soheilipour
Position
Assistant Professor of Gastroenterology and Hepatology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Al-Zahra Medical Education Center, Sofe Ave ,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0983136201991
Email
maryamsoheilip@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available