Evaluation of the effectiveness of Lactobacillus reuteri probiotics in the treatment of chronic functional abdominal pain in children aged 5 to 15 years
Determining the effectiveness of Lactobacillus reuteri in the treatment of functional abdominal pain in children
Design
180 children with functional abdominal pain, one group of 90 people receiving Lactobacillus reuteri probiotic and another 90 children as a control group, receive a placebo. This is a double-blind study. Random allocation software is used to randomize and each code is typed on the medicine package that the doctor will give the patient a complete questionnaire and description
Settings and conduct
Reuteflor packages are coded after randomization and are given to the relevant doctor in Mofid Children's hospital in Tehran and Besat in Hamedan or the private office and then to the patients. The doctor, patients, and their parents are blinded. The packages of both study groups are quite similar.
Participants/Inclusion and exclusion criteria
The boy or girl is 5 to 15 years old.
Admission is based on the Rome 4 criteria.
1. Abdominal pain is persistent or almost constant.
2. Pain has nothing to do with physiological events in the body (eating, defecation, menstruation, etc.).
3. Some daily functions are lost.
4. Pain is not fake.
5. Symptoms to complement the criteria for other gastrointestinal functional disorders do not fully explain the pain.
All of these criteria must be present for at least three months and the onset of symptoms at least six months before diagnosis. The child should not have an underlying disease that causes abdominal pain that is diagnosed by a pediatric gastroenterologist.
Intervention groups
A group of 90 patients receive a probiotic sachet every day for 28 days.
A control group of 90 patients receive a placebo sachet with the same original packaging every day for 28 days.
Main outcome variables
Pain intensity; Pain frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023084N14
Registration date:2021-12-30, 1400/10/09
Registration timing:prospective
Last update:2021-12-30, 1400/10/09
Update count:0
Registration date
2021-12-30, 1400/10/09
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 probiotics in the treatment of chronic functional abdominal pain in children aged 5 to 15 years
Public title
Evaluation of the probiotic effect of Lactobacillus reuteri in the treatment of chronic functional pain in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Abdominal pain is persistent or almost constant
Pain has nothing to do with physiological events in the body (eating, defecation, menstruation, etc.)
Some daily functions are lost
The pain is not fake
Symptoms to complete the criteria for other gastrointestinal functional disorders do not justify complete pain
All of these criteria must be present for at least three months and the onset of symptoms at least six months before diagnosis
Exclusion criteria:
The doctor determines that the child has chronic abdominal pain due to the consumption of a certain type of food (special diet) or a specific organic problem.
Existence of an underlying disease that, according to the pediatric gastroenterologist, has caused abdominal pain.
Age
From 5 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:
180
Randomization (investigator's opinion)
Randomized
Randomization description
The identical packages of probiotic sachets or placebo (identified by codes 1 or 2) are randomly distributed among the people. The doctor randomly gives the patient a pack using the lottery method.
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. The packages are identified by codes that do not show the content. In the end, the analyzer, who is the only person who knows each code's meaning, reviews and evaluates the findings.
Placebo
Used
Assignment
Parallel
Other design features
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.1400.301
Health conditions studied
1
Description of health condition studied
chronic functional abdominal pain in children
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
Intensity of pain
Timepoint
Every day for 28 days
Method of measurement
Based on oucher pain scale
2
Description
Frequent pain
Timepoint
Every day for 28 days
Method of measurement
Record in the table
3
Description
Duration of treatment
Timepoint
28 days
Method of measurement
Check the questionnaire table
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lactobacillus reuteri probiotic. 28 sachets One gram of probiotic is dissolved in sachets of water, yogurt or food (cold) every day and consumed for 28 days. Each sachet of 1 g of Reuteflor contains 300 mg of Lactobacillus reuteri lyophilized active cell (equivalent to 8 ^ 10 × 8 CFU). Other ingredients: maltodextrin, cornstarch, magnesium stearate, silicon dioxide, inulin and natural banana flavoring. This product is free of gluten, talc, sweetener and milk ingredients.The company manufactures probiotics and placebos is farabiotic, both of which are delivered in exactly the same shape. The doctor will give the questionnaire along with the medicine to the patient with a full explanation. Store at a cool, dry temperature (below 25 ° C). No need to store in the refrigerator.
Category
Treatment - Drugs
2
Description
Control group: Lactobacillus reuteri placebo. 28 sachets One gram of placebo dissolves one sachet in water, yogurt or food (cold) every day and is consumed for up to 28 days. Each 1 gram placebo sachet contains maltodextrin, cornstarch, magnesium stearate, silicon dioxide, inulin and natural banana flavoring. This product is free of gluten, talc, sweetener and milk ingredients.The company manufactures probiotics and placebos is farabiotic, both of which are delivered in exactly the same shape. The doctor will give the questionnaire along with the medicine to the patient with a full explanation. Store at a cool, dry temperature (below 25 ° C). No need to store in the refrigerator.