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Assessment the effect of a drug in the treatment of abdominal pain in childre

Phase 2
Conditions
Functional abdominal pain.
Other and unspecified abdominal pain
R10.4
Registration Number
IRCT20190304042914N1
Lead Sponsor
Babol University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
64
Inclusion Criteria

FAP diagnosis based on Rome III criteria

Exclusion Criteria

Immunodeficiency
Consumption of probiotics or prebiotics within 7 days before participating in the study
Chronic underlying disease
Malignancy
The presence of red flags includes a pain that awakens the baby
Continuous pain of RUQ or RLQ
Vomiting (biliary, frequent, periodic, or disturbing for the physician)
Fever without cause
Urogenital Symptoms
Dysphagia
Severe chronic diarrhea or Nocturnal diarrhea
Gastrointestinal bleeding
Unwanted weight loss
Downtrend in the growth curve
Delayed puberty
Family history of IBD
Celiac and PUD
Localized tenderness in RUQ or RLQ
Localized mass
Splenomegaly
Jaundice
CVA tenderness
Arthritis
Vertebral tenderness
Disease in the perianal area
Abnormal or unreasonable findings in the examination
Hematochezia
Anemia
Hepatomegaly
Antibiotic use in the last month

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Frequency of pain. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: check list.
Secondary Outcome Measures
NameTimeMethod
umber of absentee days from school. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Check list.;Pain intensity. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Face scaling.
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