IRCT | Evaluation and comparison of the therapeutic effects of probiotics, Bismuth subsalicylate and placebo in patients with abdominal bloating in patients referring to gastrointestinal clinic in Khorshid hospital.

Protocol summary

Study aim: Evaluation and comparison of the therapeutic effect of probiotics, bismuth subsalciate and placebo in patients with abdominal bloating
Design: Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 100 patients. The random number table function was used to randomize.
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 3 groups. Patients, researchers, 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: In this study, all patients with bloating enter. Inclusion criteria include: 1. Age between 20 and 50 years 2. Having functional abdominal bloating based on Rome III criteria 3. Feeling bloated for at least 3 days a month for the last 3 months Exclusion criteria: 1. Any history of chronic inflammatory disease or structural gastrointestinal disease 2. Any serious physical illness or illness, such as inflammation or malignancy 3. Abnormal experiments 4. Use of calcium channel blockers in the last 3 months 5. Severe stress in the last 6 months
Intervention groups: Group 1 receive Familact probiotic tablets by Zist-tskhmir company containing 7 bacterial strains (Lactobacilli, Bifidobacteria, Streptococcus thermophilus) every 12 hours after the main meal. Group 2 Bismuth Subsalicylate Pills will receive 120 mg every 12 hours after a meal. Group 3 will also receive placebo tablets containing starch in the same way every 12 hours. The duration of treatment is 8 weeks.
Main outcome variables: Abdominal bloating

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200601047621N1

Registration date: 2020-06-18, 1399/03/29

Registration timing: prospective

Last update: 2020-06-18, 1399/03/29

Update count: 0
Registration date: 2020-06-18, 1399/03/29

Registrant information: Name

Maryam Soheilipour

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 31 3729 4502

Email address

maryamsoheilip@med.mui.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2020-07-29, 1399/05/08
Expected recruitment end date: 2020-11-03, 1399/08/13
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluation and comparison of the therapeutic effects of probiotics, Bismuth subsalicylate and placebo in patients with abdominal bloating in patients referring to gastrointestinal clinic in Khorshid hospital.

Public title: Probiotics Bismuth Subsalicylate and Abdominal Bloating
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

All of the Patients with Abdominal Bloating Age between 20 and 50 years Feeling bloated for at least 3 days a month for the last 3 months The first experience of bloating more than 6 months ago

Exclusion criteria:

Any history of chronic inflammatory disease or structural disease of the gastrointestinal tract Any serious physical problems or illness, such as inflammation or malignancy Use of calcium channel blockers in the last 3 months Severe stress in the last 6 months Positive family history for Colon Concert History of inflammatory diseases Lactase deficiency disease Celiac disease
Age: From 20 years old to 50 years old
Gender: Both

Phase

2-3

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor

Sample size

Target sample size: 100

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 0-33 for group 1, numbers 34-66 for group 2, and numbers 67-99 for group 3. 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 3 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. After the course of treatment, to assess the effectiveness of the medication, the assessor does not know which patient has been treated with what medication and only fills in the information related to the questionnaires.

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

No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan

City

Isfahan

Province

Isfehan

Postal code

6719674255
Approval date: 2020-05-31, 1399/03/11
Ethics committee reference number: IR.MUI.MED.REC.1399.193

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 group1: 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

2

Description: Intervention group2: Subsalicyte bismuth receptor. Patients in this group will receive 120 mg of bismuth subsalicylate tabletsproduced by Abo-reyhan company every 12 hours after a meal. The duration of treatment will be 8 weeks.
Category: Treatment - Drugs

3

Description: Control group: Plasbo recipient. Patients in this group will use placebo tablets containing starch or a similar appearance to the tablets used in the other two groups for 8 weeks.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Khorshid Hospital

Full name of responsible person

Maryam Soheilipour

Street address

Khorshid hospital, Ostandari Blvd., Isfahan

City

Isfahan

Province

Isfehan

Postal code

6719674255

Phone

+98 31 3729 4225

Email

maryamsoheilip@med.mui.ac.ir

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Shaghayegh Haghjoo

Street address

No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan

City

Isfahan

Province

Isfehan

Postal code

6719674255

Phone

+98 31 3729 4079

Email

haghjoo.sh@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

Maryam Soheilipour

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Internal Medicine

Street address

No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan

City

Isfahan

Province

Isfehan

Postal code

6719674255

Phone

+98 31 3729 4225

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

Maryam Soheilipour

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Internal Medicine

Street address

No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan

City

Isfahan

Province

Isfehan

Postal code

6719674255

Phone

+98 31 3729 4225

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

Maryam Soheilipour

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Internal Medicine

Street address

No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan

City

Isfahan

Province

Isfehan

Postal code

6719674255

Phone

+98 31 3729 4225

Email

maryamsoheilip@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: All potential data can be shared after people have been identified
When the data will become available and for how long: Late 2020
To whom data/document is available: Researchers working in academic and scientific institutions
Under which criteria data/document could be used: Free and on Web Individuals can use the documents by visiting the research sites and the website of Isfahan University of Medical Sciences
From where data/document is obtainable: Free and on Web. Individuals can use the documents by visiting the website of Isfahan University of Medical Sciences and submitting an application
What processes are involved for a request to access data/document: Apply online through the university website and issue a license within about 2 weeks after approval and apply for data access
Comments

Evaluation and comparison of the therapeutic effects of probiotics, Bismuth subsalicylate and placebo in patients with abdominal bloating in patients referring to gastrointestinal clinic in Khorshid hospital.