Effect of Intracellular Content From Lactobacillus Casei CRL-431 on Antioxidant Capacity of Breast Milk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-04-30

Brief Summary

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The objective of the present study was to evaluate the effect of the consumption of the intracellular content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast milk

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Detailed Description

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A double blind randomized controlled clinical study of an 30-d intervention with 16 nursing mothers was carried out to evaluate the effect of the consumption of the intracellular content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast milk. Once obtained the informed consent; volunteers were ramdomized into two groups (n=8) to either receive 5 mL daily: edible gel with intracellular content of Lb. casei CRL-431 (intervention group) or edible gel without intracellular content of Lb. casei CRL-431 as control (placebo). Both gels were consumed daily. Participants were asked not to change their diet or lifestyle during the intervention. We applied intention to treat for those participants who did not have good adherence and those who withdraw the study. The outcomes between groups were analyzed using a independent samples student t-test, with P value of 0.05 or less (two sided) when there was a statistical differences. Non-parametric data were analyzed with Mann-Whitney test; using statistical software.

Conditions

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Mothers Lactation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Daily consumption of 5 mL of edible gel with intracellular content of Lactobacillus casei CRL-431 during 30-d

Group Type EXPERIMENTAL

Postibiotic formulation

Intervention Type DIETARY_SUPPLEMENT

5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431

Placebo

Daily consumption of 5 mL of edible gel without intracellular content of Lactobacillus casei CRL-431 during 30-d

Group Type PLACEBO_COMPARATOR

Placebo formulation

Intervention Type DIETARY_SUPPLEMENT

5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431

Interventions

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Postibiotic formulation

5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431

Intervention Type DIETARY_SUPPLEMENT

Placebo formulation

5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Nursing mothers between 3 and 52 weeks of lactation

Exclusion Criteria

* Clinical evidence of chronic disease or gastrointestinal disorders
* Structural defects in the breast (breast surgery, mammary gland hypoplasia, among others)
* Mastitis
* Cancer and/or radiotherapy
* Consumption of: antioxidant supplements, probiotics, symbiotics and/or antibiotics in the month prior to recruitment.
* Alcohol or drugs consumption

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes