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L.Fermentum CECT5716 in Treatment of Breast Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02093338
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : March 21, 2014
Sponsor:
Collaborators:
Funding: The Agency of Innovation and Development of Andalusia
Statistical analysis: SEPLIN Soluciones Estadísticas
Information provided by (Responsible Party):
Biosearch S.A.

Brief Summary:
The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women with breast pain

Condition or disease Intervention/treatment Phase
Breast Pain Dietary Supplement: Lactobacillus fermentum CECT5716 Other: Placebo Comparator: maltodextrin Not Applicable

Detailed Description:
  1. Type of study Nutritional intervention study, multicenter, randomized, blinded, parallel group included 25 women per group

    • Group 1: 3x109 cfu / day (n = 25)
    • Group 2: 6x109 cfu / day (n = 25)
    • Group 3: 9x109 cfu / day (n = 25)
    • Group 4: placebo (n = 25)
  2. Statistical calculation of sample size. The calculation of sample size was calculated by the company SEPLIN Solutions Statistics. The primary endpoint was the bacterial count of in milk. The sample size obtained to observe a difference of 1 log10, with a power of 0.80 and a significance level of 0.05 was 20 volunteers per group.
  3. Randomization Randomization was performed using a list of random numbers generated by computer. Subjects will be randomized in a strictly sequential.

    If a subject is removed from the test, the number that was assigned randomization not be reused again.

  4. Overall design and outline of the study At visit 1 we require the informed consent of the patient. It will take the milk sample, we will review the implementation of the inclusion and exclusion criteria. Be randomized and explain the treatment guidelines to be followed, the data to be collected and medical appointments that must go (2 and 3 weeks). It will complete the pain assessment questionnaire (MQP) and nutrition survey.

    On visits 2, 3 and 4 corresponding to 1, 2 and 3 weeks of intervention will collect milk sample pain assessment survey and nutrition survey.

    Milk samples (5 mL) were collected aseptically in sterile tubes to be frozen immediately until analysis to be carried out within seven days.

  5. Intervention duration The intervention will last three weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Intervention Nutritional, Multicenter, Randomized, Blind, Parallel Group to Evaluate the Efficacy of Lactobacillus Fermentum CECT5716 to Reduce the Load Bacterial in Potential Pathogens in Milk of Mothers With Breast Pain
Study Start Date : July 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Experimental: fermentum 3x
Lactobacillus fermentum CECT5716 at 3x10e9 cfu/day
Dietary Supplement: Lactobacillus fermentum CECT5716
Experimental: fermentum 6x
Lactobacillus fermentum CECT5716 at 6x10e9cfu/day
Dietary Supplement: Lactobacillus fermentum CECT5716
Experimental: fermentum 9x
Lactobacillus fermentum CECT5716 at 9x10e9cfu/day
Dietary Supplement: Lactobacillus fermentum CECT5716
Placebo Comparator: maltodextrin
maltodextrin
Other: Placebo Comparator: maltodextrin
Placebo




Primary Outcome Measures :
  1. Change from baseline Staphylococcus count at 3 weeks [ Time Frame: 0, 3 weeks ]
    Counts of Staphylococcus in breast milk


Secondary Outcome Measures :
  1. Change from baseline Streptococcus counts at 3 weeks [ Time Frame: 0, 3 weeks ]
    Streptococcus counts in breast milk

  2. Change from Breast pain score at 3 weeks [ Time Frame: 0, 3 weeks ]
    evaluation of breast pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

· breast-feeding women

  • Swelling and / or warmth in the chest
  • Chest pain
  • total bacteria count in milk greater than or equal to 3 log10 colony forming units (CFU) / mL,

Exclusion Criteria:

  • breast abscesses, Raynaud syndrome,
  • Antibiotic treatment
  • Allergic to antibiotics
  • Low expectation of compliance with the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093338


Locations
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Spain
Hospital Virgen de las Nieves
Granada, Spain, 18012
Sponsors and Collaborators
Biosearch S.A.
Funding: The Agency of Innovation and Development of Andalusia
Statistical analysis: SEPLIN Soluciones Estadísticas
Investigators
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Principal Investigator: Dr. Miguel A Díaz López, Doctor Gynecology Service of Virgen de las Nieves Hospital, Granada (Spain)

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Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT02093338    
Other Study ID Numbers: P025
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: March 2014
Keywords provided by Biosearch S.A.:
breast pain
probiotic
mastitis
lactobacillus fermentun
Staphylococcus
Additional relevant MeSH terms:
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Mastodynia
Pain
Neurologic Manifestations
Signs and Symptoms