An Examination of the Efficacy of Probiotics in Ameliorating Functional Constipation in Pediatric and Adolescent Populations
Design
Double-blind, randomized, placebo-controlled trial with 170 children, assessing probiotics' efficacy for functional constipation, using concealed, computerized randomization
Settings and conduct
Digestion; Among the patients of Bandar Abbas city; receiving lactulose with probiotics in the intervention group and lactulose with placebo in the control group; blinding of participants; Researchers and analysts
Participants/Inclusion and exclusion criteria
Demographic Age Group, Adherence to Rome IV Criteria, Related Recent Pharmacological Interventions, Surgical History Pertinent to Condition, Allergenic Reactions and Sensitivities, and Informed Consent for Study Participation
Intervention groups
Intervention Group: Participants in this group will receive probiotic treatment. The specific dosage of the probiotics is indicated on the medication packaging and is visible to the patients to ensure proper administration. The duration of the treatment, the frequency of administration, and any follow-up procedures are clearly defined and will be monitored throughout the study.
Control Group: Participants in this group will receive a placebo, an inert substance designed to look and taste like the probiotic treatment but without the active probiotic ingredients. The placebo will be administered in the same manner and dosage as indicated on its packaging, mirroring the probiotics in the Intervention Group. This group acts as a baseline to compare the effects of the probiotics.
Main outcome variables
Functional constipation based on Rome IV criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231004059611N1
Registration date:2024-01-08, 1402/10/18
Registration timing:prospective
Last update:2024-01-08, 1402/10/18
Update count:0
Registration date
2024-01-08, 1402/10/18
Registrant information
Name
Samira Zakeri Shahvari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 7200
Email address
samirashahvari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Therapeutic Effectiveness of Probiotics on Pediatric Functional Constipation in a Cohort Aged 2 to 12 Years
Public title
Probiotics in the Management of Functional Constipation in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 2 to 12 years
Having functional constipation based on Rome criteria 4
Not using probiotics, prebiotics or antibiotics 4 weeks before the start of the research
No history of gastrointestinal surgery
Lack of sensitivity or tolerance to Lactobacillus roteri (Reuteflor)
Interest in participating in the study and consent of family/guardian
Exclusion criteria:
Children with organic digestive disorders or any other underlying disease that can affect bowel function.
Children with mental disability
Current use of medications that affect bowel function such as laxatives or antidiarrheals
History of using probiotics, prebiotics or antibiotics 4 weeks before the start of the research
Inability or unwillingness to comply with the study protocol or follow-up
History of participating in a different clinical trial in the last 3 months
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Unit: Individual participants.
Method: Equal and independent chance of being assigned to either group, without age or characteristic stratification.
Tool: Random allocation software for unbiased, random sequence generation.
Sequence Generation: Pre-generated random sequence for assigning participants upon enrollment.
Allocation Concealment: Hidden sequence from the research team to prevent selection bias.
This approach ensures a fair and transparent allocation, maintaining the integrity and reliability of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and Caregivers: Unaware of whether receiving probiotics or placebo.
Researchers and Principal Investigator: Blind to treatment allocation to prevent bias in study management and interpretation.
Healthcare Personnel (Physicians, Nurses, etc.): Not informed of individual treatments to ensure unbiased patient care.
Data Collectors and Outcome Assessors: Kept blind to avoid influence on data recording or result interpretation.
Data Safety and Monitoring Committee: Not Blinded
Treatments, prepared by a third-party manufacturer, are coded and labeled indistinguishably. The manufacturer holds the treatment codes securely, only to be revealed after study completion or in medical emergencies.
Participants are fully informed about their trial participation, but specific treatment details are withheld per double-blind study design, ensuring ethical conduct and study validity.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Chamran Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2023-08-04, 1402/05/13
Ethics committee reference number
IR.HUMS.REC.1402.220
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
Functional Constipation based on ROME IV Criteria
Timepoint
Initial Presentation and Subsequent Observations on Days 7, 14, 21, and 28, as well as Two Months Post-Administration of Probiotics
Method of measurement
ROME IV Criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Reuteflor oral sachet, each Reuteflor sachet contains 800 million active lyophilized cells of Lactobacillus roteri (equivalent to 8*10^8 CFU), 1 to 2 sachets per day or according to the doctor's opinion, for use in children over two years of age and adolescents. and adults, the duration of use is 28 days, dissolve the contents of one sachet in a quantity of liquid or solid food compounds that are allowed by a doctor or pharmacist, such as water, yogurt or (cold) food and immediately Consume up to thirty minutes before. Make sure that the content of the sachet is well dissolved in the liquid, yogurt or food before consumption. Manufacturer: Faradaro Fan Avar Mehr Company (Farabiotic)
Category
Treatment - Drugs
2
Description
Control group: Receiving placebo, dosage, number of times of use, duration of use, method of use as in the intervention group. Manufacturer: Faradaro Fan Avar Mehr Company (Farabiotic)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bandar Abbas Children's Hospital
Full name of responsible person
Samira Zakeri Shahvari
Street address
Emam Khomeini Blvd., Daroupakhsh Ave.
City
Bandar Abbas
Province
Hormozgan
Postal code
7915873665
Phone
+98 76 3366 6240
Email
kdkh@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Vali Alipour
Street address
Imam Hossein Blvd, Nabovat Town, Campus of Hormozgan University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Samira Zakeri Shahvari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Emam khomeyni Blvd, Daroupakhsh St.
City
Bandar Abbas
Province
Hormozgan
Postal code
7915873665
Phone
+98 76 3366 7200
Email
samirashahvari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Samira Zakeri Shahvari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Emam khomeyni Blvd, Daroupakhsh St.
City
Bandar Abbas
Province
Hormozgan
Postal code
7915873665
Phone
+98 76 3366 7200
Email
samirashahvari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sobhan Montazerghaem
Position
medical scholar
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Jomhouri Eslami Blvd. ,Boostan St.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919916663
Phone
+98 76 3334 1460
Email
sobhan_mono@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
Investigative Elements Comprising Individual Participant Data (IPD), Study Protocol, Statistical Analysis Blueprint, Informed Consent Documentation, Clinical Study Report, Analytical Coding Framework, and Data Categorization System. A portion of this data, specifically pertaining to the principal outcome, will be designated for scholarly sharing.
When the data will become available and for how long
Availability Period Commencing Approximately Six Months Subsequent to the Dissemination of the Final Published Article
To whom data/document is available
Investigators Affiliated with Academic and Scientific Institutions
Under which criteria data/document could be used
For the Purpose of Evaluating the Data Analysis Methodology, Execution of the Plan Utilizing Diverse Data Sets, Sampling Techniques, Randomization Processes, and Data Stratification, Alongside Assessment of the Exclusion Criteria for Disqualified Participants.
From where data/document is obtainable
Electronic Mail Contact Information of the Principal Project Coordinator: samirashahvari@gmail.com
Bandar Abbas Children's Hospital and Hormozgan University of Medical Sciences
What processes are involved for a request to access data/document
Full Name and Surname
Contact Information: Including Email Address and Mobile Number (where applicable)
Academic Qualifications: Degree(s) Held
Current Occupational Title and Position
Field of Specialization: Specific Academic and Professional Focus
Affiliated Organization: Name of the Institution or Entity
Intended Purpose for Data Utilization
Proposed Methodology for Data Interaction and Analysis