Evaluation of probiotic use (Lactobacillus reuteri) in children between ages of 2 and 14 with chronic functional constipation; Double-blind randomized clinical trial.
1- Determining the recovery rate (relative risk) in the use of probiotics and placebo in the recovery of children with chronic constipation after 7 weeks of treatment based on ROME IV criteria
2- Determining the mean difference in the length of the treatment period in the group receiving probiotics and the placebo group
3- Determining the relative risk of drug side effects in the group receiving probiotics compared to the placebo group during the 7-week treatment period
Design
Controlled clinical trial with parallel groups, double-blind, randomized, phase 3 on 60 patients. Lottery of sealed envelopes was used for randomization.
Settings and conduct
Children admitted to the pediatric gastroenterology clinic of Imam Ali Hospital (AS) who are diagnosed with functional constipation enter the study.
Each patient will randomly choose one of the sealed envelopes and open it. Inside each envelope is code A or B, based on which the person will receive medicine A or B. Only the main researcher of the research is aware of the assignment of the codes.
Information on the primary endpoint (Rome IV criteria) and secondary endpoints (abdominal pain, side effects and need for rescue treatment) at visits one to six (on entry, one week later, week 3, week 5 and week 7) will be obtained and finally compared between the studied groups.
Participants/Inclusion and exclusion criteria
Children between the ages of 2 and 14 who refer to the children's clinic of Imam Ali (AS) hospital with the complaint of constipation should their parents be able to fully follow the doctor's orders and do not suffer from serious and chronic physical or mental diseases
Intervention groups
Lactobacillus lutheri probiotic recipient group
placebo group
Main outcome variables
Rome IV criteria; Abdominal pain; side effects; Need for rescue treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160117026069N5
Registration date:2023-01-26, 1401/11/06
Registration timing:registered_while_recruiting
Last update:2023-01-26, 1401/11/06
Update count:0
Registration date
2023-01-26, 1401/11/06
Registrant information
Name
Fereshteh Ansari
Name of organization / entity
Razi Vaccine and Serum Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 26 3405 0400
Email address
ansarif@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotic use (Lactobacillus reuteri) in children between ages of 2 and 14 with chronic functional constipation; Double-blind randomized clinical trial.
Public title
Evaluation of probiotic use in chronic functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from functional constipation according to Rome IV criteria
Age 2 to 14 years
Enforceability of orders by the child's parents
Exclusion criteria:
Children with organic causes of constipation including celiac disease, intestinal obstruction, hypothyroidism, anorectal malformation, CF
Serious chronic health problems that affect the child's ability to participate in the study, such as metabolic, heart, kidney, and liver diseases
Unwanted weight loss equal to or more than 5% of the current weight during the last three months
Gastrointestinal bleeding
Recurrent or unexplained fever
History of abdominal surgery including gastrointestinal surgery, except for appendix removal or hernia repair
Simultaneous use of drugs that affect the movements of the digestive system
History of increased sensitivity or allergy to experimental drugs
Diagnosis of autism symptoms
Severe mental problems such as bipolar disorder, schizophrenia, and severe depression
Use of (SNS) or antegrade enemas during cecostomy or appendicostomy
Age
From 2 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelopes are considered as the number of patients, whose content determines which group each person belongs to. One of these envelopes is selected for each patient by lottery, and then this envelope is opened and the allocation of the patient will be determined after opening the envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only the main researcher of the research is aware of the assignment of the codes, and until the end of the research, it will not be clear for the patient, the treating physician and those who evaluate the results, whether A or B is a placebo or the studied probiotic combination.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Saffarian Alley, Golshahr Blvd, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2022-11-12, 1401/08/21
Ethics committee reference number
IR.ABZUMS.REC.1401.202
Health conditions studied
1
Description of health condition studied
Functional constipation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Treatment of functional constipation
Timepoint
The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7
Method of measurement
doctor checkup
2
Description
Abdominal pain
Timepoint
The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7
Method of measurement
doctor checkup
3
Description
Side effects
Timepoint
The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7
Method of measurement
doctor checkup
4
Description
Need for rescue treatment
Timepoint
The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7
Method of measurement
doctor checkup
Secondary outcomes
empty
Intervention groups
1
Description
Pidrolax drug (Pidrolax 4000 powder, 70g packets, made by Sepidaj Daru Company) is prescribed according to the following method: Children's dose 2 to 6 years old: 5 grams (one tablespoon) dissolved in a quarter of a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. Children from 7 to 14 years old: 10 grams (one tablespoon) dissolved in half a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. The patient should be repeated, and then in the following days, according to the patient's response status, the drug dose should be adjusted so that he has at least one soft stool per day. In case of no response despite taking the maximum dose of Pidrolox, the situation should be reported to the project manager. To take the necessary measures to correct the treatment. The main drug under investigation is the probiotic Lactobacillus roteri (Roteflor powder, produced by Farabiotic Company) in the form of one-gram sachets containing 300 mg of lyophilized active cells (equivalent to 8x10⁸ CFU), which according to the doctor's prescription, one sachet per day in half a glass of cold liquid or yogurt It is solved and consumed. In the first session, complete explanations about the treatment process, how to take medicines, diet, necessary behavioral training and danger signs are given to the parents, and the patient's information and history are recorded. After the start of the treatment, in the weeks 1st, 3rd, 5th and 7th, during a phone call or in person (according to the discretion of the patient's parents), the patient's condition is measured and the course of the symptoms is recorded, and the necessary corrections are applied in the way of implementing the treatment or any side issues that arise. The treatment is carried out for 7 weeks, and the parents are advised to avoid stopping or changing the medication without coordinating with the doctor. If the child has not had a stool for three consecutive days, life-saving treatment with liquid paraffin medicine with a dose of 1-3 cc /kg will be used.
Category
Treatment - Drugs
2
Description
Pidrolax drug (Pidrolax 4000 powder, 70g packets, made by Sepidaj Daru Company) is prescribed according to the following method: Children's dose 2 to 6 years old: 5 grams (one tablespoon) dissolved in a quarter of a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. Children from 7 to 14 years old: 10 grams (one tablespoon) dissolved in half a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. The patient should be repeated, and then in the following days, according to the patient's response status, the drug dose should be adjusted so that he has at least one soft stool per day. In case of no response despite taking the maximum dose of Pidrolox, the situation should be reported to the project manager. To take the necessary measures to correct the treatment. The control group will receive placebo which is similar to the main drug, a powder produced by Farabiotic Company in the form of one-gram sachets which according to the doctor's prescription, one sachet per day in half a glass of cold liquid or yogurt It is solved and consumed. In the first session, complete explanations about the treatment process, how to take medicines, diet, necessary behavioral training and danger signs are given to the parents, and the patient's information and history are recorded. After the start of the treatment, in the weeks 1st, 3rd, 5th and 7th, during a phone call or in person (according to the discretion of the patient's parents), the patient's condition is measured and the course of the symptoms is recorded, and the necessary corrections are applied in the way of implementing the treatment or any side issues that arise. The treatment is carried out for 7 weeks, and the parents are advised to avoid stopping or changing the medication without coordinating with the doctor. If the child has not had a stool for three consecutive days, life-saving treatment with liquid paraffin medicine with a dose of 1-3 cc /kg will be used.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam ali medical eduction and treatment center
Full name of responsible person
Kumars Pourrostami
Street address
Imam Ali Medical Education and Treatment Center, Vali-asr Blvd., Esteghlal Blvd., Esteghlal Sq.
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3447 8835
Email
dr.porrostami1975@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Vice-Chancellor for Research and Technology, Gulshahr, Safarian Alley
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
raziehlotfi@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Razi Vaccine and Serum Research Institute
Full name of responsible person
Fereshteh Ansari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Shahid Beheshti Ave., Hesarak
City
Karaj
Province
Tehran
Postal code
3197619751
Phone
+98 26 3405 0400
Fax
+98 26 3455 2194
Email
fereshtehansari66@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Kumars Pourrostami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Faculty of Medicine, West end of Bu-Ali, Nobovat Sq.
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3447 8835
Email
dr.porrostami1975@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Razi Vaccine and Serum Research Institute
Full name of responsible person
Fereshteh Ansari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Shahid Beheshti Ave., Hesarak
City
Karaj
Province
Alborz
Postal code
3197619751
Phone
+98 26 3405 0400
Fax
+98 26 3455 2194
Email
fereshtehansari66@gmail.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 of the participans' individual data
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
All researchers working in academic and scientific institutions and people working in the industry
Under which criteria data/document could be used
If a request with this theme is received, a decision will be made with the opinion of the research team.
From where data/document is obtainable
To the project manager, Dr. Kyomarth Pourrostami
What processes are involved for a request to access data/document
After submitting the request to the project manager, this request will be reviewed by a committee with the presence of all the people involved in the project, and then if the committee gives a positive answer, the data will be provided to the applicant.