Pediatric Antibiotic Associated Diarrhea

Diarrhea Clinical Trial

— TURPENADA  

Official title:

Incidence, Risk Factors and Severity of Pediatric Antibiotic Associated Diarrhea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03265730
• Other study ID #: Hacettepe01
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2017
• Last updated: November 28, 2017
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2017
• Source: Hacettepe University
• Contact: Sevgen Tanir Basaranoglu, MD
• Phone: + 90 532 7498624
• Email: sevgent[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Barbut F, Meynard JL. Managing antibiotic associated diarrhoea. BMJ. 2002 Jun 8;324(7350):1345-6. — View 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. — View 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. Review. — View Citation

Wiström J, Norrby SR, Myhre EB, Eriksson S, Granström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey	How common the antibiotic associated diarrhea is encountered in pediatric age group in outpatient clinic in Turkey.	December 2018
Secondary	Local differences in pediatric AAD across Turkey	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.	December 2018
Secondary	Follow-up of Severity of AAD in Outpatient Clinics and by Phone Calls for Two Months Period in Pediatric Population in Turkey.	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.	December 2018
Secondary	Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic	Incidence of antibiotic associated diarrhea with different class of antibiotics will be determined	December 2018
Secondary	Incidence of antibiotic associated diarrhea in different age groups	Differences in incidence and severity of AAD in children with different age groups.	December 2018