The effect of colonoscopy preparation and probiotic consumption on the severity of functional constipation of the gastrointestinal tract (functional constipation and irritable bowel syndrome with constipation pattern)
The effect of colonoscopy preparation and probiotic consumption on the severity of functional constipation of the gastrointestinal tract (functional constipation and irritable bowel syndrome with constipation pattern)
Design
Non-randomized Clinical trial with control group with parallel groups, phase 2-3 on 74 patients
Settings and conduct
This study will be performed in Khorshid Hospital in Isfahan and patients with functional constipation will be admitted. In the intervention group, in addition to receiving peg powder after colonoscopy, they will receive probiotic capsules and in the control group, they will receive placebo capsules. The severity of constipation before and after interventions will be measured and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Having functional constipation according to Roman criteria 4, having irritable bowel syndrome with constipation pattern according to Roman criteria, freely and consciously written consent to participate in the study, age over 18 years
Exclusion criteria
Any history of chronic inflammatory disease or structural disease of the gastrointestinal tract, any serious physical problems or illnesses such as inflammation or malignancy, any physical problems that prevent you from doing physical activity, addiction to drugs or sleeping pills, history of chronic diseases such as diabetes
Intervention groups
Intervention group: patients will receive PEG powder pre-colonoscopy. Also, these patients will receive two bio-flora capsules (lactic acid bacteria) for 8 weeks a day (after breakfast and after dinner) and the severity of constipation will be measured.
Control group: patients will receive PEG powder pre-colonoscopy. Also, these patients will receive two placebo capsules and the severity of constipation will be measured during and after the interventions.
Main outcome variables
Constipation score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210817052219N1
Registration date:2021-10-13, 1400/07/21
Registration timing:prospective
Last update:2021-10-13, 1400/07/21
Update count:0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
Leila Khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 7626
Email address
leila.kh7501256@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-20, 1400/08/29
Expected recruitment end date
2022-12-20, 1401/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of colonoscopy preparation and probiotic consumption on the severity of functional constipation of the gastrointestinal tract (functional constipation and irritable bowel syndrome with constipation pattern)
Public title
Colonoscopy preparation and probiotic use on the severity of constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having functional constipation in people over 18 years according to ROME IV criteria
Having irritable bowel syndrome with constipation patternaccording to ROME IV criteria
Free and informed written consent to participate in the study
Age over 18 years
Exclusion criteria:
Any history of chronic inflammatory disease or structural disease of the gastrointestinal tract
Any serious physical problems or illnesses such as inflammation or malignancy
Any physical problems that prevent you from doing physical activity
Addiction to drugs or sleeping pills
History of chronic diseases such as diabetes
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-05-30, 1400/03/09
Ethics committee reference number
IR.MUI.MED.REC.1400.170
Health conditions studied
1
Description of health condition studied
Functional constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Constipation score
Timepoint
Before receiving the colonoscopy preparation and then in weeks 2, 4, 8 after the start of the intervention and 4 weeks after the end of the intervention (week 12)
Method of measurement
ROM 3 criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients will receive PEG powder before colonoscopy. After colonoscopy, patients receive two bio-flora (lactic acid bacteria) capsules from Tak Gene for 8 weeks a day (after breakfast and after dinner) and will measure the severity of constipation during and after the interventions.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients will receive PEG powder before colonoscopy. Also, these patients will receive two placebo capsules containing starch per day for 8 weeks (after breakfast and after dinner) and the severity of constipation will be measured during and after the interventions.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Khorshid Hospital
Full name of responsible person
Amir Hosseini
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8169311478
Phone
+98 31 2222 2127
Email
leila.kh7501256@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8169311478
Phone
+98 31 3222 2127
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
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8169311478
Phone
+98 31 3222 2127
Email
leila.kh7501256@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Soheilipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8169311478
Phone
+98 31 3222 2127
Email
leila.kh7501256@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Soheilipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8169311478
Phone
+98 31 3222 2127
Email
leila.kh7501256@yahoo.com
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 data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.