Determining the therapeutic effect of probiotics, metronidazole and placebo in patients with flatulence
Design
A randomized, triple-blinding clinical trial, with parallel groups, Phase 3 on 80 patients
Settings and conduct
In this triple-blind randomized clinical trial study, 80 patients with functional flatulence referring to the gastroenterology clinic of Al-Zahra Hospital in Isfahan will be included in the study and will be randomly divided into two groups. Metronidazole and probiotics will be prescribed in the intervention group and metronidazole and placebo in the control group. The intervention will be performed in such a way that the patient, the researcher and the statistical analyst will not have any knowledge of the type of intervention. Then, abdominal bloating and quality of life will be evaluated after the intervention.
Participants/Inclusion and exclusion criteria
The inclusion criteria include age between 18 and 70 years, having functional flatulence and consent to participate in the study. Exclusion criteria include having any history of chronic inflammatory disease or structural disease of the gastrointestinal tract, using calcium channel blocking drugs in the last 3 months, having a positive family history for colon cancer, celiac disease, receiving antibiotics or probiotics 8 weeks ago. of study, pregnancy or breastfeeding and alcohol consumption.
Intervention groups
Intervention group: Patients in this group receive metronidazole 500 mg every 8 hours for 2 weeks. Then regflor probiotic containing 200 mg of active lyophilized Bifidobacterium infectis cells is administered once a day 30 minutes before food consumption for 30 days.
Control group: Patients in this group receive metronidazole 500 mg every 8 hours for 2 weeks. Then, a placebo pill is prescribed once a day 30 minutes before meals for 30 days.
Main outcome variables
Flatulence; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230912059417N1
Registration date:2024-01-09, 1402/10/19
Registration timing:prospective
Last update:2024-01-09, 1402/10/19
Update count:0
Registration date
2024-01-09, 1402/10/19
Registrant information
Name
elham tabesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
tabesh.elham@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Probiotics, Metronidazole and Placebo in patients with abdominal flatulence
Public title
Investigating the effect of consecutive treatment with antibiotics and probiotics in functional flatulence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 70 years
Having functional flatulence (based on Rome III criteria based on history and risk symptoms and functional flatulence diagnostic criteria)
Abdominal flatulence feeling at least 3 days a month in the last 3 months
The first experience of flatulence is more than 6 months before the study
Informed written 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
Use of calcium channel blocking drugs in the last 3 months
Positive family history for colon cancer
Celiac disease
Any receipt of antibiotics or probiotics 8 weeks before the study
Pregnancy or breastfeeding
alcohol consumption
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the study, letter A is written on 40 sheets and letter B is written on 40 sheets, and each is placed in an envelope. Then, each eligible patient who consented to participate in the study is asked to choose an envelope from among the envelopes. In this way, the patient will be randomly assigned to one of the two groups according to the envelope selected without the interference of the researcher.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Probiotic and placebo drugs were numbered by a person unaware of the study, and the participating patients and the specialist doctor who evaluated the patients' flatulence and the assistant who followed up the patients' symptoms were not aware of the type of drug delivered to the patient, which is probiotic or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
Sofe Blvd, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2022-09-05, 1401/06/14
Ethics committee reference number
IR.MUI.MED.REC.1401.213
Health conditions studied
1
Description of health condition studied
Flatulence
ICD-10 code
R14.3
ICD-10 code description
Flatulence
Primary outcomes
1
Description
Bloating severity score
Timepoint
Before of the intervention, 2, 4, 6 and 8 weeks after the start of the study
Method of measurement
Questionnaire IBS- QOL
2
Description
Quality of life
Timepoint
Before of the intervention, 2, 4, 6 and 8 weeks after the start of the study
Method of measurement
Questionnaire IBS- QOL
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group receive metronidazole 500 mg every 8 hours for 2 weeks. Then regflor probiotic containing 200 mg of active lyophilized Bifidobacterium infectis cells is administered once a day 30 minutes before food consumption for 30 days.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive metronidazole 500 mg every 8 hours for 2 weeks. Then, a placebo pill is prescribed once a day 30 minutes before meals for 30 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Elham Tabesh
Street address
Sofe Blvd, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
tabesh.elham@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Isfahan University of Medical Sciences
Street address
Hezar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
tabesh.elham@med.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
Elham Tabesh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sofe Blvd, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
tabesh.elham@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Tabesh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sofe Blvd, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
tabesh.elham@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Tabesh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sofe Blvd, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
tabesh.elham@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD