Antibiotic Associated DiarrhoeaPhase 2BLAADNCT02626104
Bovine Lactoferrin and Antibiotic-associated Diarrhoea.
A Phase 2 study testing Bovine lactoferrin and Maltodextrin in people with Antibiotic Associated Diarrhoea, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This prospective, randomized, parallel-group, double blind, single-center study is to be conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in following departments: Department of Paediatric Gastroenterology and Nutrition, Department of Paediatrics and Nephrology, Department of Pediatric… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Antibiotic Associated Diarrhoea
- What is being tested?
- Bovine lactoferrin and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2015to 1 Mar 2017
- Phase
- Phase 2
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- acute respiratory or urinary infection requiring empiric antibiotic therapy.
- antibiotic treatment started before 24 hours prior to enrollment.
- the consent of parents or legal guardians to participate in the study
Who cannot join
- severe or generalized bacterial infection
- antibiotic therapy during the last 8 weeks
- use of probiotic during the seven days prior to enrollment
- immune disorders,
- chronic disease of the gastrointestinal tract,
- actual acute or chronic diarrhea,
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- intake of iron supplementation,
- cows milk protein allergy
- lack of consent of the parents or legal guardians to participate in the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition
Warsaw, Masovian Voivodeship, 01-184
About this study
Official title: Bovine Lactoferrin in the Prevention of Antibiotic-associated Diarrhoea in Children - a Randomized Clinical Trial.
This prospective, randomized, parallel-group, double blind, single-center study is to be conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in following departments: Department of Paediatric Gastroenterology and Nutrition, Department of Paediatrics and Nephrology, Department of Pediatric Pneumonology and Allergy, Department of Pediatrics with Medical Assessment Unit, Admissions Department. It is planned to include a total of 156 children aged between 12 months to 18 years old receiving antibiotic therapy because of acute respiratory tract infection/or urinary tract infection. The children will be randomly assigned to receive 100 mg of bovine lactoferrin or placebo twice a day orally for the whole period of antibiotic therapy. The primary efficacy parameter is occurrence of diarrhea during the antibiotic therapy and two weeks after, defined as > 3 stools a day, a watery or loose stool with/or occurrence of blood in the stool.
- Conditions
- Antibiotic Associated Diarrhoea
- Being tested
- Bovine lactoferrin, Maltodextrin
- Keywords
- lactoferrin, clostridium difficile, antibiotic associated diarrhoea, children, antibiotic therapy, diarrhoea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine lactoferrinDietary supplement
The children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy.
MaltodextrinDietary supplement
The children will be randomly assigned to receive 100 mg of placebo - maltodextrin twice a day orally for the whole period of antibiotic therapy.
| Study group | Role | What they receive |
|---|---|---|
| A - Lactoferrin | Experimental | Bovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period. Receives: Dietary Supplement: Bovine lactoferrin |
| B - Maltodextrin | Placebo comparator | Maltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of antibiotic-associated diarrhoea.
Occurrence of diarrhea up to 24 days after initiation of antibiotic treatment, defined as > 3 stools a day, a watery or loose stool with/or occurrence of blood in the stool.
Measured: Up to 24 days after initiation of antibiotic treatment.
Secondary outcomes (2)
Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.
Measured: Up to 10 days after initiation of antibiotic treatment.
Intravenous rehydration due to the antibiotic-associated diarrhea
Measured: Up to 24 days after initiation of antibiotic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Associated DiarrhoeaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmabest Sp. z o.o.
- Responsible party
- Sponsor
- Investigators
- Piotr Albrecht, Ph.D., Study chair, Department of Paediatric Gastroenterology and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626104
- Sponsor's protocol ID
- BLAAD
- Acronym
- BLAAD
- Status last verified
- Nov 2015
- First submitted
- 29 Jun 2015
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Wronowski MF, Kotowska M, Banasiuk M, Kotowski A, Kuzmicka W, Albrecht P. Bovine Lactoferrin in the Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial. Front Pediatr. 2021 Jun 7;9:675606. doi: 10.3389/fped.2021.675606. eCollection 2021.
PubMed 34164360
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bovine Lactoferrin in the Prevention of Antibiotic-associated Diarrhoea in Children - a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02626104
- Acronym / sponsor ID
- BLAAD / BLAAD
- Conditions
- Antibiotic Associated Diarrhoea
- Keywords
- lactoferrin, clostridium difficile, antibiotic associated diarrhoea, children, antibiotic therapy, diarrhoea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Pharmabest Sp. z o.o.
- Study start
- Dec 2015 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 10 Dec 2015 (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.
This prospective, randomized, parallel-group, double blind, single-center study is to be conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in following departments: Department of Paediatric Gastroenterology and Nutrition, Department of Paediatrics and Nephrology, Department of Pediatric Pneumonology and Allergy, Department of Pediatrics with Medical Assessment Unit, Admissions Department. It is planned to include a total of 156 children aged between 12 months to 18 years old receiving antibiotic therapy because of acute respiratory tract infection/or urinary tract infection. The children will be randomly assigned to receive 100 mg of bovine lactoferrin or placebo twice a day orally for the whole period of antibiotic therapy. The primary efficacy parameter is occurrence of diarrhea during the antibiotic therapy and two weeks after, defined as > 3 stools a day, a watery or loose stool with/or occurrence of blood in the stool.
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 |
|---|---|---|
| A - Lactoferrin | Experimental | Dietary Supplement: Bovine lactoferrinBovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period. |
| B - Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- acute respiratory or urinary infection requiring empiric antibiotic therapy.
- antibiotic treatment started before 24 hours prior to enrollment.
- the consent of parents or legal guardians to participate in the study
Key exclusion criteria (9 listed)
- severe or generalized bacterial infection
- antibiotic therapy during the last 8 weeks
- use of probiotic during the seven days prior to enrollment
- immune disorders,
- chronic disease of the gastrointestinal tract,
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 |
|---|---|---|
| Bovine lactoferrinThe children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy. | Dietary supplement | A - Lactoferrin |
| MaltodextrinThe children will be randomly assigned to receive 100 mg of placebo - maltodextrin twice a day orally for the whole period of antibiotic therapy. | Dietary supplement | B - Maltodextrin |
Primary outcome
Occurence of antibiotic-associated diarrhoea.
Time frame: Up to 24 days after initiation of antibiotic treatment.
Occurrence of diarrhea up to 24 days after initiation of antibiotic treatment, defined as > 3 stools a day, a watery or loose stool with/or occurrence of blood in the stool.
2 secondary outcomes
Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.
Time frame: Up to 10 days after initiation of antibiotic treatment.
Intravenous rehydration due to the antibiotic-associated diarrhea
Time frame: Up to 24 days after initiation of antibiotic treatment.
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 15 Jun 2018.
- Derived from this study: PubMed 34164360Wronowski MF, Kotowska M, Banasiuk M, Kotowski A, Kuzmicka W, Albrecht P. Bovine Lactoferrin in the Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial. Front Pediatr. 2021 Jun 7;9:675606. doi: 10.3389/fped.2021.675606. eCollection 2021.
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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.
Piotr Albrecht, Ph.D. study chair
Department of Paediatric Gastroenterology and Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bovine lactoferrin and Maltodextrin in people with Antibiotic Associated Diarrhoea, run by Medical University of Warsaw at 1 site in Poland.
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 9 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 15 Jun 2018. 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 Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Occurence of antibiotic-associated diarrhoea. (time frame: Up to 24 days after initiation of antibiotic treatment.). 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 NCT02626104, which also lists 1 linked publication.
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 15 Jun 2018.