Clinical trial NCT03265730: Pediatric Antibiotic Associated Diarrhea
Official title: Incidence, Risk Factors and Severity of Pediatric Antibiotic Associated Diarrhea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diarrhea
Keywords: Outpatient clinics
oral antibiotics
diarrhea
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey
timeFrame: December 2018
Secondary outcomes:
measure: Local differences in pediatric AAD across Turkey
timeFrame: December 2018
measure: Follow-up of Severity of AAD in Outpatient Clinics and by Phone Calls for Two Months Period in Pediatric Population in Turkey.
timeFrame: December 2018
measure: Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic
timeFrame: December 2018
measure: Incidence of antibiotic associated diarrhea in different age groups
timeFrame: December 2018
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ates Kara, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wistrom J, Norrby SR, Myhre EB, Eriksson S, Granstrom G, Lagergren L, Englund G, Nord CE, Svenungsson B. Frequency of antibiotic-associated diarrhoea in 2462 antibiotic-treated hospitalized patients: a prospective study. J Antimicrob Chemother. 2001 Jan;47(1):43-50. doi: 10.1093/jac/47.1.43.
citation: Lau CS, Chamberlain RS. Probiotics are effective at preventing Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Int J Gen Med. 2016 Feb 22;9:27-37. doi: 10.2147/IJGM.S98280. eCollection 2016.
citation: Barbut F, Meynard JL. Managing antibiotic associated diarrhoea. BMJ. 2002 Jun 8;324(7350):1345-6. doi: 10.1136/bmj.324.7350.1345. No abstract available.
citation: Szajewska H, Canani RB, Guarino A, Hojsak I, Indrio F, Kolacek S, Orel R, Shamir R, Vandenplas Y, van Goudoever JB, Weizman Z; ESPGHAN Working Group for ProbioticsPrebiotics. Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Children. J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):495-506. doi: 10.1097/MPG.0000000000001081.