Antibiotic-associated DiarrheaFLOSTRUMNCT04277156
L Rhamnosus ATCC 53103 & L Reuteri DSM 29063 Compared With L Rhamnosus ATCC 53103 for Preventing AAD in Children
A study testing Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063 and L rhamnosus ATCC 53103 in people with Antibiotic-associated Diarrhea, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This study will use a noninferiority design to examine whether the administration of L rhamnosus ATCC 53103 \& L reuteri DSM 29063 (Flostrum Baby) is no worse than (or as good as) the administration of a recommended probiotic L rhamnosus ATCC 53103 (commercially available as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063 and L rhamnosus ATCC 53103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 892 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2020to Dec 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age younger than 18 years;
- oral or intravenous antibiotic therapy which started within 24 hours of enrolment;
- signed informed consent.
Who cannot join
- pre-existing acute or chronic diarrhea, history of chronic gastrointestinal disease (e.g. inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy) or other severe chronic diseases (eg, neoplastic diseases),
- major medical problems (eg. immunocompromised, major developmental or genetic abnormality);
- taking any of the study products (or probiotic strains included in the study products) at the time of study commencement;
- use of antibiotics within 4 weeks prior to enrolment,
- prematurity;
- exclusive breastfeeding.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Paediatrics, St. Hedwig of Silesia Hospital
Trzebnica, 55-100
About this study
Official title: A Two-strain Probiotic (L Rhamnosus ATCC 53103 & L Reuteri DSM 29063) Compared With a Single Strain Probiotic (L Rhamnosus ATCC 53103) for Preventing Antibiotic-associated Diarrhea: an Open-label, Randomized, Noninferiority Trial
This study will use a noninferiority design to examine whether the administration of L rhamnosus ATCC 53103 \& L reuteri DSM 29063 (Flostrum Baby) is no worse than (or as good as) the administration of a recommended probiotic L rhamnosus ATCC 53103 (commercially available as Dicoflor, hereafter a reference product) for the prevention of antibiotic-associated diarrhea in children,
Read the detailed description
The recruitment will take place in hospitalized patients at the Pediatric Department of St. Hedwig of Silesia Hospital, Trzebnica, Poland. Additionally, patients treated at the out-patient clinics collaborating with the St. Hedwig of Silesia Hospital will be recruited. The involvement of other recruiting wards and/or sites are under consideration provided that the personnel are adequately trained and competent in conducting clinical trials. The start of the recruitment is planned in March 2020 and should be completed within the following 2 years.
The test product will be Flostrum Baby, which is a food supplement consisting of two bacterial strains: Lactobacillus rhamnosus ATCC 53103 and Lactobacillus reuteri DSM 29063, 5x10^9 CFU and 1x10^8 CFU, respectively, per seven drops.
The control product will be Dicoflor, which is a food supplement containing L rhamnosus ATCC 53103, 5x10^9 CFU, per five drops.
Caregivers will receive oral and written information regarding the study. Written informed consent will be obtained by the physicians involved in the study. Participants will be randomized within 24 hours after the initiation of the antibiotic administration.
Throughout the study period, healthcare providers and/or caregivers will record the number and consistency of stools in a standard stool diary. To record stool consistency, in children younger than 1 year, the Amsterdam Infant Stool Scale (AISS)9 will be used, and loose or watery stools will correspond to A-consistency. In children older than 1 year, the Bristol Stool Form (BSF) scale10 will be used, and loose or watery stools will correspond to scores of 5- 7. In the case of missing or incomplete data, data from hospital charts will be obtained. At any time, caregivers will have the right to withdraw the participating child from the study; they will be not obliged to give reasons for this decision, and there will be no effect on subsequent physician and/or institutional medical care.
In the event of loose or watery stools, the presence of viral or bacterial pathogens in the stool samples will be investigated. The presence of viral pathogens will be checked by using a standard rapid, qualitative, chromatographic immunoassay that simultaneously detects rotaviruses, adenoviruses, and noroviruses. Standard microbiological techniques will be used to isolate and identify bacterial pathogens (Salmonella spp, Shigella spp, Campylobacter spp, and Yersinia spp). C. difficile toxins A and B will be identified by standard enzyme immunoassay.
All study participants will be followed up for the duration of the intervention (antibiotic treatment) and then for up to 1 week after the intervention.
- Conditions
- Antibiotic-associated Diarrhea
- Being tested
- Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063, L rhamnosus ATCC 53103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063Dietary supplement
Also called Flostrum Baby
7 drops contain Lactobacillus rhamnosus GG 5x10^9 CFU; and Lactobacillus reuteri 1x10^8 CFU.
L rhamnosus ATCC 53103Dietary supplement
Also called Dicoflor
5 drops contain Lactobacillus rhamnosus 5x10^9 CFU.
| Study group | Role | What they receive |
|---|---|---|
| Flostrum Baby | Experimental | The test product will be Flostrum Baby, which is a food supplement consisting of two bacterial strains: Lactobacillus rhamnosus ATCC 53103 and Lactobacillus reuteri DSM 29063, 5x10^9 CFU and 1x10^8 CFU, respectively, per seven drops.
Flostrum Baby - in children below 12 years of age, 7 drops, twice daily; in children older than 12 years, 14 drops, twice daily. Receives: Dietary Supplement: Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063 |
| Dicoflor | Active comparator | The control product will be Dicoflor, which is a food supplement containing L rhamnosus ATCC 53103, 5x10^9 CFU, per five drops.
Dicoflor - the manufacturer recommends 5-10 drops daily, with no age specification. For the purposes of this study, 5 drops, twice daily, in children below 12 years of age; 10 drops, twice daily, in children older than 12 years. Receives: Dietary Supplement: L rhamnosus ATCC 53103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic-associated diarrhea (3 or more loose or watery stools (a score of A on the AIS Scale or 5-7 on the BSF scale) per day in a 24-hour period, caused by C. difficile infection or of otherwise unexpla
Measured: From the date of randomisation up to 7th day after antibiotic cessation
Secondary outcomes (7)
• Any diarrhea (defined as ≥ 3 loose or watery stools per day for a minimum of 24 hours regardless of its etiology).
Measured: From the date of randomisation up to 7th day after antibiotic cessation
• C difficile-associated diarrhea (CDAD) (diarrhea defined as above caused by C. difficile confirmed by the presence of toxin-producing C. difficile in stools (positive toxin tests))
Measured: From the date of randomisation up to 7th day after antibiotic cessation
• The duration of diarrhea (defined as the time until the normalization of stool consistency according to the BSF or AISS scale (on BSF scale, numbers 1, 2, 3 and 4; on AISS scale, letters B or C), and the presence of normal stools for 48 hours).
Measured: From the date of randomisation up to 7th day after antibiotic cessation
• Discontinuation of the antibiotic treatment due to severity of diarrhea.
Measured: From the date of randomisation up to 7th day after antibiotic cessation
• Hospitalization caused by diarrhea in outpatient
Measured: From the date of randomisation up to 7th day after antibiotic cessation
• Adverse events.
Measured: From the date of randomisation up to 7th day after antibiotic cessation
Number and consistency of stools
Measured: From the date of randomisation up to 7th day after antibiotic cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 892 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Adamed Pharma S.A.
- Responsible party
- Sponsor
- Investigators
- Hanna Szajewska, MD, Study chair, The Medical Univ of Warsaw, Dept of PaediatricsHenryk Szymański, MD, Principal investigator, Pediatric Department of St. Hedwig of Silesia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277156
- Sponsor's protocol ID
- FLOSTRUM2020
- Acronym
- FLOSTRUM
- Status last verified
- Jan 2020
- First submitted
- 10 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-strain Probiotic (L Rhamnosus ATCC 53103 & L Reuteri DSM 29063) Compared With a Single Strain Probiotic (L Rhamnosus ATCC 53103) for Preventing Antibiotic-associated Diarrhea: an Open-label, Randomized, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04277156
- Acronym / sponsor ID
- FLOSTRUM / FLOSTRUM2020
- Conditions
- Antibiotic-associated Diarrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 892 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Adamed Pharma S.A.
- Study start
- Feb 2020 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Feb 2020 (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.
This study will use a noninferiority design to examine whether the administration of L rhamnosus ATCC 53103 \& L reuteri DSM 29063 (Flostrum Baby) is no worse than (or as good as) the administration of a recommended probiotic L rhamnosus ATCC 53103 (commercially available as Dicoflor, hereafter a reference product) for the prevention of antibiotic-associated diarrhea in children,
Detailed description
The recruitment will take place in hospitalized patients at the Pediatric Department of St. Hedwig of Silesia Hospital, Trzebnica, Poland. Additionally, patients treated at the out-patient clinics collaborating with the St. Hedwig of Silesia Hospital will be recruited. The involvement of other recruiting wards and/or sites are under consideration provided that the personnel are adequately trained and competent in conducting clinical trials. The start of the recruitment is planned in March 2020 and should be completed within the following 2 years.
The test product will be Flostrum Baby, which is a food supplement consisting of two bacterial strains: Lactobacillus rhamnosus ATCC 53103 and Lactobacillus reuteri DSM 29063, 5x10^9 CFU and 1x10^8 CFU, respectively, per seven drops.
The control product will be Dicoflor, which is a food supplement containing L rhamnosus ATCC 53103, 5x10^9 CFU, per five drops.
Caregivers will receive oral and written information regarding the study. Written informed consent will be obtained by the physicians involved in the study. Participants will be randomized within 24 hours after the initiation of the antibiotic administration.
Throughout the study period, healthcare providers and/or caregivers will record the number and consistency of stools in a standard stool diary. To record stool consistency, in children younger than 1 year, the Amsterdam Infant Stool Scale (AISS)9 will be used, and loose or watery stools will correspond to A-consistency. In children older than 1 year, the Bristol Stool Form (BSF) scale10 will be used, and loose or watery stools will correspond to scores of 5- 7. In the case of missing or incomplete data, data from hospital charts will be obtained. At any time, caregivers will have the right to withdraw the participating child from the study; they will be not obliged to give reasons for this decision, and there will be no effect on subsequent physician and/or institutional medical care.
In the event of loose or watery stools, the presence of viral or bacterial pathogens in the stool samples will be investigated. The presence of viral pathogens will be checked by using a standard rapid, qualitative, chromatographic immunoassay that simultaneously detects rotaviruses, adenoviruses, and noroviruses. Standard microbiological techniques will be used to isolate and identify bacterial pathogens (Salmonella spp, Shigella spp, Campylobacter spp, and Yersinia spp). C. difficile toxins A and B will be identified by standard enzyme immunoassay.
All study participants will be followed up for the duration of the intervention (antibiotic treatment) and then for up to 1 week after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flostrum Baby | Experimental | Dietary Supplement: Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063The test product will be Flostrum Baby, which is a food supplement consisting of two bacterial strains: Lactobacillus rhamnosus ATCC 53103 and Lactobacillus reuteri DSM 29063, 5x10^9 CFU and 1x10^8 CFU, respectively, per seven drops. Flostrum Baby - in children below 12 years of age, 7 drops, twice daily; in children older than 12 years, 14 drops, twice daily. |
| Dicoflor | Active comparator | Dietary Supplement: L rhamnosus ATCC 53103The control product will be Dicoflor, which is a food supplement containing L rhamnosus ATCC 53103, 5x10^9 CFU, per five drops. Dicoflor - the manufacturer recommends 5-10 drops daily, with no age specification. For the purposes of this study, 5 drops, twice daily, in children below 12 years of age; 10 drops, twice daily, in children older than 12 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age younger than 18 years;
- oral or intravenous antibiotic therapy which started within 24 hours of enrolment;
- signed informed consent.
Key exclusion criteria (6 listed)
- pre-existing acute or chronic diarrhea, history of chronic gastrointestinal disease (e.g. inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy) or other severe chronic diseases (eg, neoplastic diseases),
- major medical problems (eg. immunocompromised, major developmental or genetic abnormality);
- taking any of the study products (or probiotic strains included in the study products) at the time of study commencement;
- use of antibiotics within 4 weeks prior to enrolment,
- prematurity;
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 |
|---|---|---|
| Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063Also: Flostrum Baby7 drops contain Lactobacillus rhamnosus GG 5x10^9 CFU; and Lactobacillus reuteri 1x10^8 CFU. | Dietary supplement | Flostrum Baby |
| L rhamnosus ATCC 53103Also: Dicoflor5 drops contain Lactobacillus rhamnosus 5x10^9 CFU. | Dietary supplement | Dicoflor |
Primary outcome
Antibiotic-associated diarrhea (3 or more loose or watery stools (a score of A on the AIS Scale or 5-7 on the BSF scale) per day in a 24-hour period, caused by C. difficile infection or of otherwise unexpla
Time frame: From the date of randomisation up to 7th day after antibiotic cessation
7 secondary outcomes
• Any diarrhea (defined as ≥ 3 loose or watery stools per day for a minimum of 24 hours regardless of its etiology).
Time frame: From the date of randomisation up to 7th day after antibiotic cessation
• C difficile-associated diarrhea (CDAD) (diarrhea defined as above caused by C. difficile confirmed by the presence of toxin-producing C. difficile in stools (positive toxin tests))
Time frame: From the date of randomisation up to 7th day after antibiotic cessation
• The duration of diarrhea (defined as the time until the normalization of stool consistency according to the BSF or AISS scale (on BSF scale, numbers 1, 2, 3 and 4; on AISS scale, letters B or C), and the presence of normal stools for 48 hours).
Time frame: From the date of randomisation up to 7th day after antibiotic cessation
• Discontinuation of the antibiotic treatment due to severity of diarrhea.
Time frame: From the date of randomisation up to 7th day after antibiotic cessation
• Hospitalization caused by diarrhea in outpatient
Time frame: From the date of randomisation up to 7th day after antibiotic cessation
• Adverse events.
Time frame: From the date of randomisation up to 7th day after antibiotic cessation
Number and consistency of stools
Time frame: From the date of randomisation up to 7th day after antibiotic cessation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- 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.
Hanna Szajewska, MD study chair
The Medical Univ of Warsaw, Dept of Paediatrics
Henryk Szymański, MD principal investigator
Pediatric Department of St. Hedwig of Silesia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063 and L rhamnosus ATCC 53103 in people with Antibiotic-associated Diarrhea, 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 6 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 20 Feb 2020. 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. 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 Krzysztof Korbecki, MPharm (+48 666 041 510, Krzysztof.Korbecki@adamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic-associated diarrhea (3 or more loose or watery stools (a score of A on the AIS Scale or 5-7 on the BSF scale) per day in a 24-hour period, caused by C. difficile infection or of otherwise unexpla (time frame: From the date of randomisation up to 7th day after antibiotic cessation). 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 20 Feb 2020.