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L Rhamnosus ATCC 53103 & L Reuteri DSM 29063 Compared With L Rhamnosus ATCC 53103 for Preventing AAD in Children (FLOSTRUM)

Primary Purpose

Antibiotic-associated Diarrhea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063
L rhamnosus ATCC 53103
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic-associated Diarrhea

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. age younger than 18 years;
  2. oral or intravenous antibiotic therapy which started within 24 hours of enrolment;
  3. signed informed consent.

Exclusion criteria:

  1. 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),
  2. major medical problems (eg. immunocompromised, major developmental or genetic abnormality);
  3. taking any of the study products (or probiotic strains included in the study products) at the time of study commencement;
  4. use of antibiotics within 4 weeks prior to enrolment,
  5. prematurity;
  6. exclusive breastfeeding.

Sites / Locations

  • Department of Paediatrics, St. Hedwig of Silesia Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flostrum Baby

Dicoflor

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

• Any diarrhea (defined as ≥ 3 loose or watery stools per day for a minimum of 24 hours regardless of its etiology).
• 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))
• 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).
• Discontinuation of the antibiotic treatment due to severity of diarrhea.
• Hospitalization caused by diarrhea in outpatient
• Adverse events.
Number and consistency of stools

Full Information

First Posted
February 10, 2020
Last Updated
February 18, 2020
Sponsor
Medical University of Warsaw
Collaborators
Adamed Pharma S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04277156
Brief Title
L Rhamnosus ATCC 53103 & L Reuteri DSM 29063 Compared With L Rhamnosus ATCC 53103 for Preventing AAD in Children
Acronym
FLOSTRUM
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
Collaborators
Adamed Pharma S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-associated Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
892 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flostrum Baby
Arm Type
Experimental
Arm Description
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.
Arm Title
Dicoflor
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063
Other Intervention Name(s)
Flostrum Baby
Intervention Description
7 drops contain Lactobacillus rhamnosus GG 5x10^9 CFU; and Lactobacillus reuteri 1x10^8 CFU.
Intervention Type
Dietary Supplement
Intervention Name(s)
L rhamnosus ATCC 53103
Other Intervention Name(s)
Dicoflor
Intervention Description
5 drops contain Lactobacillus rhamnosus 5x10^9 CFU.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
• 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
Title
• 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
Title
• 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
Title
• Discontinuation of the antibiotic treatment due to severity of diarrhea.
Time Frame
From the date of randomisation up to 7th day after antibiotic cessation
Title
• Hospitalization caused by diarrhea in outpatient
Time Frame
From the date of randomisation up to 7th day after antibiotic cessation
Title
• Adverse events.
Time Frame
From the date of randomisation up to 7th day after antibiotic cessation
Title
Number and consistency of stools
Time Frame
From the date of randomisation up to 7th day after antibiotic cessation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: age younger than 18 years; oral or intravenous antibiotic therapy which started within 24 hours of enrolment; signed informed consent. Exclusion criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krzysztof Korbecki, MPharm
Phone
+48 666 041 510
Email
Krzysztof.Korbecki@adamed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Szajewska, MD
Organizational Affiliation
The Medical Univ of Warsaw, Dept of Paediatrics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Henryk Szymański, MD
Organizational Affiliation
Pediatric Department of St. Hedwig of Silesia Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Paediatrics, St. Hedwig of Silesia Hospital
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

L Rhamnosus ATCC 53103 & L Reuteri DSM 29063 Compared With L Rhamnosus ATCC 53103 for Preventing AAD in Children

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