DiarrheaTURPENADANCT03265730
Pediatric Antibiotic Associated Diarrhea
An observational study of Diarrhea, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Diarrhea
- How many people
- 2,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
Sevgen Tanır Basaranoglu, MD, +90 532 7498624, sevgent@gmail.com
Ates Kara, Professor, + 90 532 4135130, ateskara@me.com
About this study
Official title: Incidence, Risk Factors and Severity of Pediatric Antibiotic Associated Diarrhea
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.
Read the 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.
- Conditions
- Diarrhea
- Keywords
- Outpatient clinics, oral antibiotics, diarrhea
- Medical subject headings
- Diarrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December 2018
Secondary outcomes (4)
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.
Measured: December 2018
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.
Measured: December 2018
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
Measured: December 2018
Incidence of antibiotic associated diarrhea in different age groups
Differences in incidence and severity of AAD in children with different age groups.
Measured: December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ates Kara, Hacettepe University
- Investigators
- Ates Kara, Professor, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265730
- Sponsor's protocol ID
- Hacettepe01
- Acronym
- TURPENADA
- Status last verified
- Nov 2017
- First submitted
- 24 Mar 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11152430Lau 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.
PubMed 26955289Barbut 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.
PubMed 12052785Szajewska 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.
PubMed 26756877
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Severity of Pediatric Antibiotic Associated Diarrhea
- ClinicalTrials.gov ID
- NCT03265730
- Acronym / sponsor ID
- TURPENADA / Hacettepe01
- Conditions
- Diarrhea
- Keywords
- Outpatient clinics, oral antibiotics, diarrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Local differences in pediatric AAD across Turkey
Time frame: December 2018
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
Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic
Time frame: December 2018
Incidence of antibiotic associated diarrhea in different age groups
Time frame: December 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Background: PubMed 11152430Wistrom 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.
- Background: PubMed 26955289Lau 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.
- Background: PubMed 12052785Barbut 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.
- Background: PubMed 26756877Szajewska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ates Kara, Professor principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sevgen Tanır Basaranoglu, MD (+ 90 532 7498624, sevgent@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey (time frame: December 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03265730, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.