PROBIOLAC: Global Effects of a Probiotic Strain on Lactating Women

• Sponsor: Universidad Complutense de Madrid (Other)
• Overall Status: Completed
• CT.gov ID: NCT01124448
• Collaborator: National Research Council, Spain (Other), University of Valencia (Other), Danone Research (Industry)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 33.1
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

In this study, the investigators will try to confirm if application of probiotic strains isolated from breast milk actually have a beneficial effect on women suffering lactational mastitis. This project has been design to offer an integrated vision of the effects of probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators propose a multidisciplinary approach involving the application of microbiological, immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The hypothesis is that probiotherapy will cause different effects on the host, and the objective is the finding of markers that may support the beneficial effect of the strain in such condition.

Condition or Disease	Intervention/Treatment	Phase
Mastitis	Biological: Lactobacillus salivarius PS2; Biological: Lactobacillus salivarius PS2	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactobacillus salivarius PS2 Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)	Biological: Lactobacillus salivarius PS2; 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
Active Comparator: Lactobacillus salivarius PS2B Lactating women without mastitis (n=15)	Biological: Lactobacillus salivarius PS2; 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days

Outcome Measures

Primary Outcome Measures

1. Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts [one week]

   Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk

Secondary Outcome Measures

1. Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples [one year]

2. Evidence of Changes in the Metabolic Profile of Urine [One year]

3. Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk [One year]

4. Evidence of Changes in the Immunological Profile of Milk [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Normal term pregnancy

• Lactating women

• Healthy breastfed infant

Women with mastitis:

• Clinical symptoms of mastitis

• Painful breastfeeding

• Count of staphylococci, streptococci and/or corynebacteria in milk higher than 3,000 colony-forming units/mL

• Leukocyte count in milk higher 6 log10/mL

Women without mastitis:

• No clinical symptoms of mastitis

• No painful breastfeeding

• Count of staphylococci, streptococci and/or corynebacteria in milk lower than 500 colony-forming units/mL

• Leukocyte count in milk lower 5 log10/mL

Exclusion Criteria:

• Allergy to cow's milk protein

• Intolerance to lactose

• Antibiotic treatment

• Breast abscess

• Raynaud syndrome

• Any parallel disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos	Madrid		Spain	28040

Sponsors and Collaborators

• Universidad Complutense de Madrid
• National Research Council, Spain
• University of Valencia
• Danone Research

Investigators

• Study Director: Juan M Rodríguez, PhD, Universidad Complutense de Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arroyo R, Martín V, Maldonado A, Jiménez E, Fernández L, Rodríguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763.
• Jiménez E, Fernández L, Maldonado A, Martín R, Olivares M, Xaus J, Rodríguez JM. Oral administration of Lactobacillus strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 2008 Aug;74(15):4650-5. doi: 10.1128/AEM.02599-07. Epub 2008 Jun 6.

• Responsible Party: Juan M. Rodríguez, Professor, PhD, Universidad Complutense de Madrid
• ClinicalTrials.gov Identifier: NCT01124448
• Other Study ID Numbers: PROBIOLAC
• First Posted: May 17, 2010
• Last Update Posted: Aug 20, 2014
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Mastitis; TFF1 protein, human

Study Results

Participant Flow

Arm/Group Title	Lactobacillus Salivarius PS2	Lactobacillus Salivarius PS2B
Arm/Group Description	Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days	Lactating women without mastitis (n=15) Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
Period Title: Overall Study
STARTED	25	15
COMPLETED	23	12
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Lactobacillus Salivarius PS2	Lactobacillus Salivarius PS2B	Total
Arm/Group Description	Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days	Lactating women without mastitis (n=15) Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days	Total of all reporting groups
Overall Participants	25	15	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.2 (7.7)	29.0 (7.8)	28.6 (7.7)
Sex: Female, Male (Count of Participants)
Female	25 100%	15 100%	40 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Spain	25 100%	15 100%	40 100%
Total milk bacterial count (initial) (log10 CFU/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [log10 CFU/mL]	4.08 (0.20)	3.19 (0.59)	3.63 (0.39)

Outcome Measures

1. Primary Outcome

Title	Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts
Description	Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk
Time Frame	one week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lactobacillus Salivarius PS2	Lactobacillus Salivarius PS2B
Arm/Group Description	Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days	Lactating women without mastitis (n=15) Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
Measure Participants	23	12
Mean (95% Confidence Interval) [log10 CFU/mL]	3.09	2.90

2. Secondary Outcome

Title	Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Evidence of Changes in the Metabolic Profile of Urine
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Evidence of Changes in the Immunological Profile of Milk
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Lactobacillus Salivarius PS2		Lactobacillus Salivarius PS2B
Arm/Group Description	Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days		Lactating women without mastitis (n=15) Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
All Cause Mortality
	Lactobacillus Salivarius PS2		Lactobacillus Salivarius PS2B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lactobacillus Salivarius PS2		Lactobacillus Salivarius PS2B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Lactobacillus Salivarius PS2		Lactobacillus Salivarius PS2B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.