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

NCT04277156 | Unknown

• 1 other identifier: FLOSTRUM2020
• Study Type: interventional
• Target: 892
• Locations: 1 country
• Sites: 1

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,

Conditions

Antibiotic-associated Diarrhea

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  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))

  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).

  From the date of randomisation up to 7th day after antibiotic cessation

• • Discontinuation of the antibiotic treatment due to severity of diarrhea.

  From the date of randomisation up to 7th day after antibiotic cessation

• • Hospitalization caused by diarrhea in outpatient

  From the date of randomisation up to 7th day after antibiotic cessation

Study Arms (2)

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.

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.

Dietary Supplement: L rhamnosus ATCC 53103

Interventions

Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063 DIETARY_SUPPLEMENT

7 drops contain Lactobacillus rhamnosus GG 5x10\^9 CFU; and Lactobacillus reuteri 1x10\^8 CFU.

Also known as: Flostrum Baby

Flostrum Baby

L rhamnosus ATCC 53103 DIETARY_SUPPLEMENT

5 drops contain Lactobacillus rhamnosus 5x10\^9 CFU.

Also known as: Dicoflor

Dicoflor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Adamed Pharma S.A.: collaborator

Study Sites (1)

Department of Paediatrics, St. Hedwig of Silesia Hospital

Trzebnica, 55-100, Poland

Location

Study Officials

• Hanna Szajewska, MD

  The Medical Univ of Warsaw, Dept of Paediatrics

  STUDY CHAIR

• Henryk Szymański, MD

  Pediatric Department of St. Hedwig of Silesia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krzysztof Korbecki, MPharm

CONTACT

+48 666 041 510; Krzysztof.Korbecki@adamed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 20, 2020
• Study Start: February 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 20, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)