NCT03265730

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

March 24, 2017

Last Update Submit

November 28, 2017

Conditions

Diarrhea

Keywords

Outpatient clinicsoral antibioticsdiarrhea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Local differences in pediatric AAD across Turkey

    December 2018

  • Follow-up of Severity of AAD in Outpatient Clinics and by Phone Calls for Two Months Period in Pediatric Population in Turkey.

    December 2018

  • Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic

    December 2018

  • Incidence of antibiotic associated diarrhea in different age groups

    December 2018

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 11152430BACKGROUND

  • 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.

    PMID: 26955289BACKGROUND

  • 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.

    PMID: 12052785BACKGROUND

  • 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.

    PMID: 26756877BACKGROUND

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ates Kara, Professor

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevgen Tanır Basaranoglu, MD

CONTACT

+ 90 532 7498624sevgent@gmail.com

Ates Kara, Professor

CONTACT

+90 532 4135130ateskara@me.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

March 24, 2017

First Posted

August 29, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)