Evaluating treatment efficacy of citalopram, symbiotic, and mebeverine for children with functional abdominal pain.

Evaluation treatment efficacy of citalopram, synbiotic, and mebeverine for children with functional abdominal pain; a randomized, placebo-controlled study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000158763

Enrollment

200

Registered

2013-02-11

Start date

2013-03-25

Completion date

2013-12-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Healthy volunteers

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

Exclusion criteria

Having gasterointestinal problems rather than functional abdomainal pain, Patients who will not use three tablets

Outcome results