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Trial registered on ANZCTR


Registration number
ACTRN12613000158763
Ethics application status
Approved
Date submitted
4/01/2013
Date registered
11/02/2013
Date last updated
31/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating treatment efficacy of citalopram, symbiotic, and mebeverine for children with functional abdominal pain.
Scientific title
Evaluation treatment efficacy of citalopram, synbiotic, and mebeverine for children with functional abdominal pain; a randomized, placebo-controlled study.
Secondary ID [1] 281783 0
391299
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children's functional abdominal pain 287888 0
Children mental health 288035 0
Condition category
Condition code
Oral and Gastrointestinal 288267 288267 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 288408 288408 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In citalopram group children take oral citalopram tablet 10 mg/day for one week and then 20 mg/day for three weeks.
In mebeverine group children take oral mebeverine tablet 135 mg/twice daily for four weeks.
In symbiotic group children take oral Lactol tablet (150 million spores + 100 mg FOS) twice daily for four weeks.
In placebo group children take oral placebo tablet twice daily for four weeks.
Intervention code [1] 286141 0
Treatment: Drugs
Comparator / control treatment
One placebo tablet( identical in taste and appearance to citalopralm,Lactol and mebeverin but without the active ingredient) twice a day for 4weeks
Control group
Placebo

Outcomes
Primary outcome [1] 288443 0
Clinical Global Impression-Global Improvement (CGI-I)

For detecting the abdominal pain improvement.
Timepoint [1] 288443 0
At the end of treatment (week four)
Primary outcome [2] 288636 0
clinical Global Impression-severity(CGI-S)

To detect changing in severity of abdominal pain
Timepoint [2] 288636 0
At the end of 4 weeks
Primary outcome [3] 288637 0
Wang-Baker Faces Pain Rating Score

To detect changing in abdominal pain rate
Timepoint [3] 288637 0
At the end of four weeks
Secondary outcome [1] 300172 0
Clinical Global Impression-Global Improvement (CGI-I)

For detecting the abdominal pain improvement
Timepoint [1] 300172 0
12 weeks after the end of treatment
Secondary outcome [2] 300675 0
clinical Global Impression-severity(CGI-S)

To detect changing in severity of abdominal pain
Timepoint [2] 300675 0
12 weeks after the end of treatment
Secondary outcome [3] 300676 0
Wang-Baker Faces Pain Rating Score

To detect changing in abdominal pain rate
Timepoint [3] 300676 0
12 weeks afte the e d of treatment

Eligibility
Key inclusion criteria
Children between 6 to 18 years old, having functional abdominal pain according to ROME III criteria, having not consumption of probiotics and antibiotics in previous 2 months
Minimum age
6 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Having gasterointestinal problems rather than functional abdomainal pain,

Patients who will not use three tablets

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4775 0
Iran, Islamic Republic Of
State/province [1] 4775 0
Isfahan

Funding & Sponsors
Funding source category [1] 286519 0
University
Name [1] 286519 0
Isfahan university of medical siences
Address [1] 286519 0
Isfahan university of medical siences, Hezarjaribj Ave Isfahan,Iran

Postcode: 81647-2384
Country [1] 286519 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Isfahan University of medical silences
Address
Isfahan university of medical siences, Hezarjarib Ave,Isfahan,Iran

Postcode: 81647-2384
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 285352 0
Other
Name [1] 285352 0
Child health promotion research center
Address [1] 285352 0
Emam hosein children hospital,Emam Khomeini Ave, Isfahan ,Iran.

Post code :81577-2342
Country [1] 285352 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288592 0
Ethics committe of Isfahan University of Medical Sciences
Ethics committee address [1] 288592 0
Isfahan university of medical sciences,Hejarjarib Ave,Isfahan,Iran

Post code:81647-2384
Ethics committee country [1] 288592 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 288592 0
06/08/2012
Approval date [1] 288592 0
06/09/2012
Ethics approval number [1] 288592 0
391299

Summary
Brief summary
The objective of this study is to evaluate the effect of citalopram, mebeverine, and synbiotic on children functional abdominal pain. This study is randomized - placebo controlled trial. Children age 6 to 18 year old with functional abdominal pain will be assigned in to four groups of 50 person each. Group one: will receive citalopram 10 mg/day in first week and 20 mg/day for fallowing 3 weeks. Group2: children will take 270 mg/day mebeverine for four weeks. Group3: Children in this group will consume Lactol (300 million spores plus 200 mg FOS) for four weeks. In control group children take placebo for four weeks. Clinical Global Impression for severity (CGI-s) and Wang-Baker Faces pain Rating will be measured at the baseline and at the end of treatment (week four) and at the end of study (12weeks latter) also Clinical Global Impression for Improvement CGI-I will be measured at week four and week 12. patients will be followed up at week 2 by phone and at week four and 12 be interviewed and physical examination will be done to evaluate medical tolerance and drug side effects
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35000 0
Dr Zahra Pourmoghaddas
Address 35000 0
Emam Hosein Children Hospital,Emam Khomeini Ave, Isfahan,iran.

Post code:81577-2342
Country 35000 0
Iran, Islamic Republic Of
Phone 35000 0
+989131864168
Fax 35000 0
Email 35000 0
Zahrapormoghadas@yahoo.com
Contact person for public queries
Name 18247 0
Dr Zahra Pourmoghaddas
Address 18247 0
Emam Hosein Children Hospital,Emam Khomeini Ave, Aisfahan,Iran

81577-2342
Country 18247 0
Iran, Islamic Republic Of
Phone 18247 0
+989131864168
Fax 18247 0
Email 18247 0
Zahrapormoghadas@yahoo.com
Contact person for scientific queries
Name 9175 0
Dr Zahra Pourmoghaddas
Address 9175 0
Emam Hosein Children Hospital,Emam Khomeini Ave, Aisfahan,Iran

Post code:81577-2342
Country 9175 0
Iran, Islamic Republic Of
Phone 9175 0
+989131864168
Fax 9175 0
Email 9175 0
Zahrapormoghadas@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary