This study was a randomized double-blind placebo-controlled trial. Children aged 4 to 16 years with chronic functional abdominal pain (based on Rome III criteria) that referred to Mousavi Hospital in Zanjan, were enrolled in the study. The main inclusion criteria include: the children with functional abdominal pain (FAP) according to Rome III diagnostic criteria and the main exclusion criteria include: the children with organic abdominal pain. In this study, 80 patients were enrolled, which were randomly divided in two groups (case and control groups). The first group (case group) was given probiotic from Lactobacillus family and Reuteri strain (BioGaia® brand manufactured by Sweden Health Care company) with dose 5 drops per day orally equivalent of 108 CFU (Colony-Forming Units) for 4 weeks. The second group (control group) received placebo for the same period. Patients were followed up during and 4 weeks after cessation of treatment. On follow up period frequency and severity of pain, other symptoms and drug side effects were carefully recorded. The purpose of the study was to evaluate the effect of Lactobacillus Reuteri in treatment of children with functional abdominal pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014083018971N1
Registration date:2014-09-22, 1393/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-22, 1393/06/31
Registrant information
Name
Kambiz Eftekhari
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7301 3000
Email address
k-eftekhari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
All costs of this study have been funded by the research department of Zanjan University of Medical Sciences.
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Lactobacillus Reuteri for treatment of children with Chronic Functional abdominal pain
Public title
Lactobacillus Reuteri for treatment of children with abdominal pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include: All children aged 4 to 16 years with functional abdominal pain (FAP) according to Rome III diagnostic criteria
Exclusion criteria include: Have an abdominal pain with known organic cause; history of abdominal and gastrointestinal surgery; FTT or weight loss more than 5% of body weight; any abnormal paraclinical evaluations and history of drug use in the past 3 months (including antidepressants or laxatives).
Age
From 4 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Science
Street address
Zanjan
City
Zanjan
Postal code
4513956183
Approval date
2014-02-08, 1392/11/19
Ethics committee reference number
ZUMS.REC.1392.192
Health conditions studied
1
Description of health condition studied
Abdominal Pain
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
frequency of abdominal pain
Timepoint
Baseline, one month after starting treatment and one month after discontinuing the drugs
Method of measurement
numbers of pain episode per month recorded.
2
Description
intensityof abdominal pain
Timepoint
Baseline, one month after starting treatment and one month after discontinuation of the treatment
Method of measurement
Pain intensity was assessed according to the Wong-Baker faces scale systems.
Secondary outcomes
1
Description
Assoiated Sign
Timepoint
Baseline, one month after starting treatment and one month after discontinuing the drugs
Method of measurement
Based on history and clinical examination
2
Description
Side Effects and complication
Timepoint
Baseline, one month after starting treatment and one month after discontinuing the drugs
Method of measurement
Based on history and clinical examination
Intervention groups
1
Description
The first group (case group) was given probiotic from Lactobacillus family and Reuteri strain (BioGaia® brand manufactured by Sweden Health Care company) with dose 5 drops per day orally equivalent of 108 CFU (Colony-Forming Units) for 4 weeks.
Category
Treatment - Drugs
2
Description
The second group (control group) was given placebo with dose 5 drops per day orally for 4 weeks.