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ClinicalTrials.gov Identifier: NCT03265730
Recruitment Status : Unknown
Verified November 2017 by Ates Kara, Hacettepe University. Recruitment status was: Recruiting
Diarrhea is one of the side effects of antibiotics. Antibiotic associated diarrhea can be encountered between two hours to two months after starting of antibiotics. The purpose of the study is to determine incidence,risk factors and severity of pediatric antibiotic associated diarrhea in Turkey.
Condition or disease
Antibiotic associated diarrhea is a common adverse effect, occurring about 5-30% of patients either early during treatment or up to two months after the cessation of the treatment. The frequency differs according to the definition of diarrhea, the inciting antimicrobial agent and the host factors such geriatric age, immunosuppression, prolonged hospitalization. Almost all agents, especially the the ones acting on anaerobes may cause diarrhea. Clinical presentations range from mild diarrhea to fulminant pseudomembranous enterocolitis. In Turkey still data about antibiotic associated diarrhea is not enough. Incidence and the factors that effect severity are not known.
Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey [ Time Frame: December 2018 ]
How common the antibiotic associated diarrhea is encountered in pediatric age group in outpatient clinic in Turkey.
Secondary Outcome Measures :
Local differences in pediatric AAD across Turkey [ Time Frame: December 2018 ]
Differences in incidence and severity of AAD in children in different cities in Turkey.
The incidence of antibiotic associated diarrhea will be expressed as proportion of new cases of diarrhea to total number of patients in the follow-up period of patients who receive oral antibiotics. The overall ratio will be calculated at the end of whole study period.
Follow-up of Severity of AAD in Outpatient Clinics and by Phone Calls for Two Months Period in Pediatric Population in Turkey. [ Time Frame: December 2018 ]
Duration of AAD and interventional requirements of pediatric patients who develop AAD.
Development of diarrhea during study period will be determined by using Bristol Stool Charts. Stool charts will be provided to parents by the investigators. The parents will follow number and shape and consistency of stool , and decide according to the Bristol Stool Chart. Four times and more defecation and stool in type 5,6 and 7 according to Bristol Chart that will continue for a minimum of 2 days will be regarded as diarrhea. If the diarrhea necessitates hospitalization and/or intravenous hydration therapy, this will be regarded as severe diarrhea. If patient with diarrhea will treated by just observation and diarrhea will subside spontaneously, diarrhea will be regarded as mild.
Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic [ Time Frame: December 2018 ]
Incidence of antibiotic associated diarrhea with different class of antibiotics will be determined
Incidence of antibiotic associated diarrhea in different age groups [ Time Frame: December 2018 ]
Differences in incidence and severity of AAD in children with different age groups.
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Layout table for eligibility information
Ages Eligible for Study:
1 Month to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Children who admit to outpatient clinics and are ordered oral antibiotics for acute infections such as upper and lower respiratory tract infections, infections of mouth, urinary tract infections, skin and soft tissue infections.
The parents and the child who give consent
The children who are treated for the acute infections in the outpatient clinics and whole treatment is completed in the outpatient clinics.
Children who are born mature, for the children who are younger than 1 year of age.
The parents and child who do not give consent
Children who have primary and secondary immunosuppressive states.
Children who had abdominal/gastrointestinal tract surgery in the past.
Children who had used probiotics/prebiotics in the last one month period.
Children who had used antibiotics in the last one month period.
Children who has accompanying gastrointestinal symptoms.
Children who are using anti-acid treatment at the time of involvement.