Evaluation of the effectiveness of Lactobacillus reuteri probiotic versus placebo in the treatment of functional constipation in children 3 to 18 years old
Evaluation of the effectiveness of Lactobacillus reuteri probiotic against placebo in the treatment of functional constipation in children aged 3 to 18 years
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 160 patients. Used to randomize the physician to randomly deliver packets containing medication or placebo to the patient.
Settings and conduct
The study was performed in the gastrointestinal clinic of Mofid Hospital in Tehran and Besat Hospital in Hamadan in a double-blind manner (neither the physician nor the patients were aware of the contents of the sachets received by the patients regarding the presence of probiotics or placebo).
Participants/Inclusion and exclusion criteria
To enter the study, children must be over 3 years old and under 18 years old. Functional constipation is diagnosed according to Rome IV criteria.
Before starting the study, people whose constipation has major causes such as Hirschsprung's disease, Bifida spine, hypothyroidism or other metabolic or renal disorders and mental retardation or other diseases related to the large and small intestine. Intestinal obstruction as well as the presence of kidney or heart failure are not included in the study
Intervention groups
A group of 80 people who accidentally received a probiotic
Main outcome variables
1. Number of bowel movements
2. Stool consistency
3. The number of Painful stools
4. abdominal pain
5. Stool incontinence
6. appetite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023084N13
Registration date:2021-12-29, 1400/10/08
Registration timing:prospective
Last update:2021-12-29, 1400/10/08
Update count:0
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Lactobacillus reuteri probiotic versus placebo in the treatment of functional constipation in children 3 to 18 years old
Public title
Evaluation of the effect of Lactobacillus reuteri probiotic in functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with functional constipation according to ROME IV criteria
Diagnosis of functional constipation should be based on a pediatric gastroenterologist
Age range 3 to 18 years
Exclusion criteria:
Having other underlying diseases
History of allergies to the studied drugs and their accessories
Use of any probiotics and prebiotics and laxatives other than study drugs and outside the study conditions
Age
From 3 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
After receiving the drug and placebo packages from Farabiotic Company, 160 codes were randomly distributed between the boxes by the epidemiologist. Only the epidemiologist is aware of the type of codes and the drugs were delivered to a specialist after randomization to reach the relevant patients.
Randomization was simple and individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed in a double-blind manner so that neither the physician nor the patients are aware of the contents of the sachets received by the patients based on the presence of probiotics or placebo. One group contains Lactobacillus reuteri and the other placebo and the doctor randomly give the patient a packet of the drug group. Finally, the results are reviewed and evaluated by the study evaluator by reviewing the collected data and equivalence with the package codes.
Placebo
Used
Assignment
Parallel
Other design features
This study is performed in two parts. In the first part, the studied drug (probiotic or placebo) along with polyethylene glycol is given to patients (as standard treatment) for 28 days, and in the second part, the polyethylene glycol drug is discontinued and only probiotic or placebo is given to the patient for 28 days.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Department of Pharmaceutical Sciences, Tehran Islamic Azad University of Medical
Street address
Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch
City
Tehran
Province
Tehran
Postal code
193956466
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.IAU.PS.REC.1400.302
Health conditions studied
1
Description of health condition studied
functional constipation in children
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Stool stiffness
Timepoint
Stool stiffness is recorded daily in the questionnaire by individuals for 56 days
Method of measurement
Review by Bristol form and registration by the participant in the questionnaire form
2
Description
number of Painful stools
Timepoint
56 days
Method of measurement
Daily record by individual
3
Description
Stool incontinence
Timepoint
56 days
Method of measurement
Daily record by individual
4
Description
abdominal pain
Timepoint
56 days
Method of measurement
Daily record by individual
5
Description
Appetite
Timepoint
56 days
Method of measurement
Daily record by individual
6
Description
Age
Timepoint
Before starting the intervention
Method of measurement
Registered by a pediatric gastroenterologist
7
Description
Sex
Timepoint
Before starting the intervention
Method of measurement
Registered by a pediatric gastroenterologist
8
Description
Duration of treatment
Timepoint
At the end of the study
Method of measurement
Registered by a pediatric gastroenterologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: includes 80 patients who are diagnosed with functional constipation by a pediatric gastroenterologist for 28 days of probiotic Lactobacillus reuteri produced by Farabiotic Company(one sachet daily) plus polyethylene glycol as standard treatment and then next 28 days They only take probiotics. patients are generally treated with probiotics for 56 days and fills out a questionnaire form given to them by their doctor on a daily basis.
Category
Treatment - Drugs
2
Description
Control group: includes 80 patients diagnosed with functional constipation by a pediatric gastroenterologist for 28 days of polyethylene glycol as standard treatment with placebo sachets Contains all the ingredients in the main sachets of our probiotic medicine except the probiotic itself. they take the main drug according to the instructions, and for the next 28 days, they consume only placebo sachets. In total, they use the placebo sachets produced by Farabiotic Company for 56 days as a control group and fill in the relevant questionnaire.