Determining and comparing the number of bowel movements during a week and the number of unwanted bowel movements during the day and the number of painful bowel movements during a week and the number of cases of abdominal pain during a week and the consistency of stool in the study groups
Design
Double-blind clinical trial, with factorial groups, phase 3 on 150 patients
Settings and conduct
This study is a double-blind clinical trial study performed on children with chronic functional constipation referred to the pediatric clinics of Shariati and Gharzi medical centers in Isfahan. All forms of medicine used are labeled the same and only labeled by the consulting pharmacist. First, the necessary explanations on how to implement the plan are provided to the parents, and then the informed consent form is completed by the child's legal guardian. Then, 150 patients with chronic functional constipation are selected based on inclusion and non-inclusion criteria and are randomly divided into 2 groups of 75 people. Information is recorded in a questionnaire by asking parents. Forms are anonymous and coded. Is filled and the treating physician does not witness this process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: chronic functional constipation, age 2 to 15 years
Conditions of non-entry: diseases of the large and small intestine, allergy to polyethylene glycol, intestinal obstruction, kidney or heart failure
Intervention groups
The first group (A) consumes 1 g / kg body weight of water-soluble polyethylene glycol powder daily and the second group (B) consumes one sachet of Kidi Lactate probiotic powder and 1 g / kg body weight of water-soluble polyethylene glycol daily.
Main outcome variables
Number of bowel movements; Number of unwanted bowel movements; Number of painful bowel movements; Number of abdominal pain; Determination and comparison of fecal consistency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210525051398N1
Registration date:2021-05-30, 1400/03/09
Registration timing:prospective
Last update:2021-05-30, 1400/03/09
Update count:0
Registration date
2021-05-30, 1400/03/09
Registrant information
Name
Pegah Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 2222 1761
Email address
pgh.kaveh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic use in children with functional constipation
Public title
The effect of probiotic use in children with functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with functional constipation
Between 2 to 15 years old
Exclusion criteria:
Diseases of the large and small intestine
Sensitivity to polyethylene glycol
Intestinal obstruction
Kidney or heart failure
Age
From 2 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Limited randomization with 75-person blocks is performed by the consulting pharmacist using a random number table of Random Allocation Software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial study performed on children with chronic functional constipation referred to the pediatric clinics of Shariati and Gharzi medical centers in Isfahan. All forms of medicine used are labeled the same and only labeled by the consulting pharmacist. First, the necessary explanations on how to implement the plan are provided to the parents, and then the informed consent form is completed and signed by the child's legal guardian. The personal details of the children participating in the project will be confidential. The required information will be collected by asking the parents and recorded in the relevant questionnaire. The forms are filled in anonymously and in coded form and the treating physician does not witness this process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University - Shahrood Branch
Number of bowel movements during one week at the beginning of the study (before the intervention) and 7 and 14 days after taking probiotics
Method of measurement
The required information is collected by asking the parents and recorded in the prepared questionnaire
2
Description
Number of unwanted bowel movements during the day
Timepoint
Number of unwanted bowel movements during the day at the beginning of the study (before the intervention) and 7 and 14 days after taking probiotics
Method of measurement
The required information is collected by asking the parents and recorded in the prepared questionnaire
3
Description
Number of painful bowel movements in a week
Timepoint
Number of painful bowel movements during one week at the beginning of the study (before the intervention) and 7 and 14 days after the start of probiotic use
Method of measurement
The required information is collected by asking the parents and recorded in the prepared questionnaire
4
Description
The number of times abdominal pain occurs in a week
Timepoint
The frequency of abdominal pain during one week at the beginning of the study (before the intervention) and 7 and 14 days after taking probiotics
Method of measurement
The required information is collected by asking the parents and recorded in the prepared questionnaire
5
Description
Determination and comparison of fecal consistency
Timepoint
Determination and comparison of fecal consistency at the beginning of the study (before the intervention) and 7 and 14 days after probiotic use
Method of measurement
The required information is collected by asking the parents and recorded in the prepared questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group is dissolved Kidi Lactate probiotic powder in a dose of 1 sachet per day in water and 1 g / kg body weight of water-soluble polyethylene glycol powder is given daily for 2 weeks. At first, it is recommended to consume less food. High fat and dairy and recommend eating more fruits, vegetables and high fiber foods. Parents are also given the necessary training on using the toilet and encouraging their children to go to the toilet, and it is recommended that they exercise regularly and use the toilet after each meal.
Category
Treatment - Drugs
2
Description
Control group: 1 g / kg body weight of water-soluble polyethylene glycol powder is given daily for 2 weeks. Parents are also instructed in using the toilet and encouraging their children to go to the toilet, and it is recommended that they exercise regularly and use the toilet after each meal.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Pegah Kaveh
Street address
Chaharbagh bala Ave
City
Isfahan
Province
Isfehan
Postal code
8173745384
Phone
+98 31 3627 2001
Email
Shariati_isf.hos@tamin.ir
Web page address
https://shariati-isf.tamin.ir/
2
Recruitment center
Name of recruitment center
Gharazi hospital
Full name of responsible person
Pegah Kaveh
Street address
Dr Gharazi St, Kaveh Ave
City
Isfahan
Province
Isfehan
Postal code
8196973133
Phone
+98 31 3450 9901
Email
Gharazi.hos@tamin.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahebali Manafi
Street address
Daneshgah Blvd
City
Shahrood
Province
Semnan
Postal code
3619943189
Phone
+98 23 3239 4530
Email
Info@iau-shahrood.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?