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Pediatric Antibiotic Associated Diarrhea

NCT ID: NCT03265730

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Diarrhea

Keywords

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Outpatient clinics oral antibiotics diarrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Ates Kara

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ates Kara, Professor

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sevgen Tanır Basaranoglu, MD

Role: CONTACT

Phone: + 90 532 7498624

Email: [email protected]

Ates Kara, Professor

Role: CONTACT

Phone: +90 532 4135130

Email: [email protected]

Facility Contacts

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Sevgen Tanır Basaranoglu, MD

Role: primary

Ates Kara, Professor

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 11152430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26955289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12052785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26756877 (View on PubMed)

Other Identifiers

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Hacettepe01

Identifier Type: -

Identifier Source: org_study_id