Antibiotic Associated DiarrheaPhase 3AADreuterNCT01295918
Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children
A Phase 3 study testing L reuteri in children on antibiotics in people with Antibiotic Associated Diarrhea and Clostridium Difficile Infection, run by St Marina University Hospital, Varna, Bulgaria at 2 sites in Bulgaria.
Trial summary
The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections in children and adolescents. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Antibiotic Associated Diarrhea, Clostridium Difficile Infection, Gastroenteritis
- What is being tested?
- L reuteri in children on antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesBulgaria
- Study dates
- Feb 2011to Sep 2013
- Phase
- Phase 3
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 3 - 18 years of age
- Receiving antibiotics for not more than 48 hours prior to enrolment and free from diarrhoea
- The signed informed consent by one/both parents / legal guardian and by the subject if she/he is 12 years or older
- Available throughout the study period
- No use of any other probiotic products during the study period (Bulgarian yoghurt without added probiotics can be used)
- Subject or parents/guardian should have the mental ability to understand and willingness to fulfil all the details of the protocol
Who cannot join
- Three or more soft and unformed or watery stools per day at admission
- Receiving chemotherapy or radiation therapy
- Diagnosis of inflammatory bowel disease
- Enteral or parenteral nutrition only
- Requiring care in an intensive care unit
- Status post-bowel resection during hospitalization
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- Receiving antibiotics four weeks prior to hospitalization
- Patient with severe life threatening illness or immunocompromised (HIV/AIDS, cancer, genetic disorders including cystic fibrosis, children with opportunistic infections, metabolic diseases)
- Pregnancy
- Lack of possibility to store the study product in a temperature below 25°C during the hot season of the year
Trial locations and contacts
2 sites in 1 country.
Bulgaria2 sites
St Marina University Hospital
Varna, 9002
Department of Pediatrics at St Marina University Hospital, Varna
Varna, 9010
About this study
Official title: Efficacy of the Probiotic Lactobacillus Reuteri in Prevention of Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children and Adolescents
The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections in children and adolescents.
Read the detailed description
Antibiotic-associated diarrhoea (AAD) occurs in up to 25% of all individuals receiving antibiotics (Bartlett, 2002). In hospitalized patients, AAD is related to significant increases in mortality, length of stay, and cost of medical care (McFarland, 2006). Twenty-nine percent of hospitalized patients may develop diarrhoea after antibiotic use; therefore, identifying strategies to minimize antibiotic-associated diarrhoea could be of significant medical and economic advantage (McFarland, 1998). A promising tool in this area is the probiotic Lactobacillus reuteri
- Being tested
- L reuteri in children on antibiotics
- Keywords
- probiotic, AAD, Lactobacillus reuteri, diarrhea
- Medical subject headings
- Clostridium Infections, Gastroenteritis, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L reuteri in children on antibioticsDietary supplement
Each patient will be assigned to receive either a probiotic supplement containing 1 x 10 8 CFU Lactobacillus reuteri DSM 17938 in the form of one chewable tablet once per day (BioGaia AB, Stockholm, Sweden) or placebo, identical in taste and appearance. The probiotic or placebo will be taken 2 hours after lunch each day, during the entire period of antibiotic treatment and for an additional 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo, antibiotic, diarrhea | No intervention | Not described |
| L. reuteri, Antibiotic, diarrhoea | Placebo comparator | L. reuteri will be ingested by patients on antibiotic therapy, effect of probiotic on AAD will be assessed. Receives: Dietary Supplement: L reuteri in children on antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if the probiotic L. reuteri is effective in preventing AAD in children
Incidence of diarrhea during and after treatment with antibiotics in patients ingesting L. reuteri versus placebo during the study period, measured as mean number of episodes per patient. An episode of diarrhea is defined as three or more (≥ 3) soft and unformed or watery bowel movements per day for at least 48 hours.
Measured: 2 years
Secondary outcomes (4)
Incidence of mild diarrhea and severity if diarrhea in children with probiotic treatment
Incidence of mild diarrhoea during and after treatment with antibiotics in patients ingesting L. reuteri versus placebo during the study period is measured as mean number of episodes per patient. An episode of mild diarrhoea is defined as any soft and unformed or watery bowel movements not fulfilling the definition of AAD.
Measured: 2 years
Severity of diarrhoea in patients ingesting L. reuteri versus placebo
Severity of diarrhoea in patients ingesting L. reuteri versus placebo is measured as the total number of soft and unformed or watery bowel movements during an episode of diarrhoea and the presence of blood and mucus in faeces.
Measured: 2 years
Frequency of stool samples positive for C. difficile toxin A and B
Frequency of stool samples positive for C. difficile toxin A and B at baseline, when presenting with diarrhoea during the study period, and at the follow-up 21 days post-antibiotic treatment is done to detect possible clearance of C. difficile, in patients ingesting L. reuteri versus placebo.
Measured: 2 years
Frequencies of other gastrointestinal symptoms
Frequencies of other gastrointestinal symptoms during antibiotic use and 7 and 21 days after cessation of antibiotic use, in the L. reuteri group versus placebo is to be assessed by the validated GSRS score (Gastrointestinal Symptom Rating Score, Svedlund et al., 1988).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Associated 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Marina University Hospital, Varna, Bulgaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miglena Georgieva, St Marina University Hospital, Varna, Bulgaria
- Investigators
- Miglena I Georgieva, PhD, Principal investigator, Pediatric gastroenterology ward
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295918
- Sponsor's protocol ID
- 128/13.01.2011
- Acronym
- AADreuter
- Status last verified
- Sep 2013
- First submitted
- 14 Feb 2011
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Probiotic Lactobacillus Reuteri in Prevention of Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children and Adolescents
- ClinicalTrials.gov ID
- NCT01295918
- Acronym / sponsor ID
- AADreuter / 128/13.01.2011
- Keywords
- probiotic, AAD, Lactobacillus reuteri, diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St Marina University Hospital, Varna, BulgariaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Feb 2011 (estimated)
- 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.
The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections in children and adolescents.
Detailed description
Antibiotic-associated diarrhoea (AAD) occurs in up to 25% of all individuals receiving antibiotics (Bartlett, 2002). In hospitalized patients, AAD is related to significant increases in mortality, length of stay, and cost of medical care (McFarland, 2006). Twenty-nine percent of hospitalized patients may develop diarrhoea after antibiotic use; therefore, identifying strategies to minimize antibiotic-associated diarrhoea could be of significant medical and economic advantage (McFarland, 1998). A promising tool in this area is the probiotic Lactobacillus reuteri
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo, antibiotic, diarrhea | No intervention | – |
| L. reuteri, Antibiotic, diarrhoea | Placebo comparator | Dietary Supplement: L reuteri in children on antibioticsL. reuteri will be ingested by patients on antibiotic therapy, effect of probiotic on AAD will be assessed. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 3 - 18 years of age
- Receiving antibiotics for not more than 48 hours prior to enrolment and free from diarrhoea
- The signed informed consent by one/both parents / legal guardian and by the subject if she/he is 12 years or older
- Available throughout the study period
- No use of any other probiotic products during the study period (Bulgarian yoghurt without added probiotics can be used)
Key exclusion criteria (10 listed)
- Three or more soft and unformed or watery stools per day at admission
- Receiving chemotherapy or radiation therapy
- Diagnosis of inflammatory bowel disease
- Enteral or parenteral nutrition only
- Requiring care in an intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L reuteri in children on antibioticsEach patient will be assigned to receive either a probiotic supplement containing 1 x 10 8 CFU Lactobacillus reuteri DSM 17938 in the form of one chewable tablet once per day (BioGaia AB, Stockholm, Sweden) or placebo, identical in taste and appearance. The probiotic or placebo will be taken 2 hours after lunch each day, during the entire period of antibiotic treatment and for an additional 7 days. | Dietary supplement | L. reuteri, Antibiotic, diarrhoea |
Primary outcome
To assess if the probiotic L. reuteri is effective in preventing AAD in children
Time frame: 2 years
Incidence of diarrhea during and after treatment with antibiotics in patients ingesting L. reuteri versus placebo during the study period, measured as mean number of episodes per patient. An episode of diarrhea is defined as three or more (≥ 3) soft and unformed or watery bowel movements per day for at least 48 hours.
4 secondary outcomes
Incidence of mild diarrhea and severity if diarrhea in children with probiotic treatment
Time frame: 2 years
Severity of diarrhoea in patients ingesting L. reuteri versus placebo
Time frame: 2 years
Frequency of stool samples positive for C. difficile toxin A and B
Time frame: 2 years
Frequencies of other gastrointestinal symptoms
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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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.
Miglena I Georgieva, PhD principal investigator
Pediatric gastroenterology ward
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L reuteri in children on antibiotics in people with Antibiotic Associated Diarrhea and Clostridium Difficile Infection, run by St Marina University Hospital, Varna, Bulgaria at 2 sites in Bulgaria.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess if the probiotic L. reuteri is effective in preventing AAD in children (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2013.