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The effect of whey in the treatment of functional constipation in children aged 1 to 16 years old

Protocol summary

Study aim
Determination of the effect of whey in the treatment of functional constipation in children aged 1 to 16 years old referred to pediatric gastroenterology clinics in Yazd
Design
Clinical trials with community based and pragmatic control group, with parallel groups, without blindness, randomized
Settings and conduct
In this study, children aged 1 to 16 years with chronic functional constipation are included in the study. Patient information are recorded in the questionnaire. According to the randomized table, patients enter two groups. In one group of patients, pidrolax powder is weighed 0.8 grams per kilogram, and the other group of pidrolax powder is given the same amount of cheese and one cup a day for one month. pidrolax powder is adjusted every four days on the basis of soft and daily stools (with advice from parents). Patients on the 15th and 30th day of treatment will be asked for information on the frequency of feces, stool consistency, incontinence, drug intake, and drug complications. .
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Children aged 1 to 16 years old with functional constipation (based on Rome IV CR), Obtain parental consent to enter the study and enter it, Possible patient tracking Excclusion criteria: Patients who have been examined in favor of organic constipation,Patients with neurological disorder, History of Anorectal Surgery, Patients who have taken medication more than six months before the study, Patients who use a drug other than Pidrolax.
Intervention groups
A group powder pidrolax and whey get Others will only receive pidrolax powder
Main outcome variables
duratio of defication; stool consistency; fecal incontinence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190122042459N1
Registration date: 2019-02-11, 1397/11/22
Registration timing: prospective

Last update: 2019-02-11, 1397/11/22
Update count: 0
Registration date
2019-02-11, 1397/11/22
Registrant information
Name
Fateme Motavasselian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3726 3907
Email address
motavasselianz@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of whey in the treatment of functional constipation in children aged 1 to 16 years old
Public title
The effect of whey in the treatment of functional constipation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 1 to 16 years chronic functional constipation for at least two months Based on Rome IV Criterion Acquiring parental consent to enter and study it Possibility of patient Follow up
Exclusion criteria:
Patients who have been diagnosed with a history of organic constipation Patients with neurological disorder History of Anorectal Surgery Patients who have taken medication more than six months before the study Patients who use a drug other than pidrolax
Age
From 1 year old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method using a random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Central office of Yazd Shahid Sadoughi University of Medical Sciences,Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8951737915
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.SSU.REC.1397.115

Health conditions studied

1

Description of health condition studied
Constipation of children
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
Times of defication
Timepoint
At first, 15 and 30 days after taking the drug
Method of measurement
Parental statements( times in week) Through the questionnaire

2

Description
Stool consistency
Timepoint
At first, 15 and 30 days after taking the drug
Method of measurement
Bristol stool chart

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: To a group of patients, Pidrolax powder is given at a dose of 0.8 g / kg , and whey is made by Niak Company for one month (120 cc) per day for one month. The amount of Pidrolax powder is adjusted every four days on the basis of soft and daily stools (with advice to parents). On the 15th and 30th day of the treatment, information on the frequency of defication, stool consistency, incontinence, drug intake, and complications of the drugs are asked.
Category
Treatment - Drugs

2

Description
Control group: To a group of patients, Pidrolax powder is given at a dose of 0.8 grams per kilogram of daily weight for one month. The amount of Pidrolax powder is adjusted every four days on the basis of soft and daily stools (with advice to parents). On the 15th and 30th day of the treatment, information on the frequency of defication, stool consistency, incontinence, drug intake, and complications of the drugs are asked.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al anbia Clinic
Full name of responsible person
Fateme Motavasselian
Street address
Taleghani Blvd
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3733 0122
Email
clinik@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzayi
Street address
Taleghani Blvd
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3726 3154
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fateme Motavasselian
Position
Phd candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 1, Etehadie Alley, Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3726 3907
Email
motavasselianz@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Sadoughi Blvd. Central Office of the University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3223 8915
Email
dr.emtiazy@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Motavasselian
Position
Phd candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 1, Etehadie Alley,Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3726 3907
Email
motavasselianz@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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