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use of minas fresh cheese with probiotics to control the prevalence of oral candidiasis

use of probiotics added to minas fresh cheese to control the prevalence of oral candidiasis– double-blind randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5hn7gn
Enrollment
Unknown
Registered
2016-05-31
Start date
2012-03-07
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study was conducted in health human , complete denture wearers, and harboring Candida sp in the oral cavity. The subjects did not present signs and symptoms of candidiasis. This study aimed to control and to prevent the levels of oral Candida infection by the consumption of probiotics (Lactobacillus). Prevention and control, oral candidiasis, complete denture, Candida, probiotics, Lactobacillus

Interventions

The subjects were sorted into 3 groups: placebo, experimental 1 and experimental 2, all 20 subjects. The placebo group corresponds to the subjects that ingested cheese without addition of probiotics
the experimental 1 ingested cheese containing Lactobacillus acidophilus NCFM (DuPont Danisco, Madison, WI, USA) and the experimental 2 ingested cheese with Lactobacillus rhamnosus Lr-32 (DuPont Danisc
Other
HP3.073.433.101
B03.353.750.450.475.100
B03.353.750.450.475.700

Sponsors

Faculdade de Odontologia da Universidade de São Paulo
Lead Sponsor
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Collaborator

Eligibility

Age
40 Years to 90 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria was voluntary patients users of prostheses, with subclinical findings for Candida in the oral cavity; with no evidence or symptoms of candidosis, but who had a positive result of the presence of the fungus after laboratory culture testing. Therefore, the individuals who do not present evidence or symptoms of oral candidiasis but present Candida was included in the research. Age was not be an exclusion factor for individual over 60 years old, even considering the elderly a vulnerable population, since the health conditions required for this group or any other participant was good general health, i.e. none of the subjects of the research can suffer from decompensated diseases, otherwise they were excluded from the research.

Exclusion criteria

Exclusion criteria: The criteria of exclusion was the presence of dementia; hypertensive patients; patients with heart diseases; transplant patients; patients with kidney diseases or those who used any type of medication to treat oral infections or had used antibiotics during the previous month; patients with intestinal complications, such as lactose or dairy products intolerance; patients presenting evidence and symptoms of oral candidosis, who were treated separately with the traditional antifungals nistatina or miconazole.

Design outcomes

Primary

MeasureTime frame
Saliva samples were collected at the beginning and at the end of intervention (8-week period), and the samples underwent to quantification method in Colony Forming Units (CFU / ml) of Candida, in order to observe the Candida sp colonization levels in the oral cavity. The reduction of these levels was determined from the range observation of at least 5%, in the pre and post intervention measurements of UFC/ ml values, by Tukey test (p <0.05) statistical analysis. The expected reduction was in experimental groups (cheese added with probiotic) when compared to the control group (placebo- cheese without probiotics).;The reduction of the oral Candida colonization levels (CFU/ml) of the subjects who consumption the cheese supplemented with probiotic was observed, in both experimental groups. In group 1 (cheese containing Lactobacillus acidophilus), the difference between the means of colonization levels, pre and post intervention, was 0.9338 ± 0.2822 log CFU/ml, 95% confidence interval (95% CI) from 1.506 to 0.3615, p = 0.0021. In group 2 (cheese containing Lactobacillus rhamnosus), the difference between the means of colonization levels, pre and post intervention, was 0.8022 ± 0.2496 log CFU / ml, 95% CI from 1.307 to 0.2970, p = 0.0027. In the control group (cheese without probiotics), the difference between the means of colonization levels, pre and post intervention, was 0.6090 ± 0.3052 log CFU/ml, 95% CI 1.227 to 0.008772, p = 0.0532. The difference was statistically significant for both experimental groups but not for the control group, according to Tukey test (p< 0.05) in the pre and post intervention measurements.

Secondary

MeasureTime frame
The values of CFU/ml greater than or equal to 3 log CFU / ml was considered high level of oral Candida colonization. Before and after the intervention, the number of individuals with high levels of Candida colonization was presented in percentage for each study group that consumed the cheese (group 1 - cheese with Lactobacillus acidophilus, group 2 - cheese with Lactobacillus rhamnosus and placebo group - cheese without probiotics). The reduction in the number of subjects with high levels of Candida was statistically analyzed by Fisher test and considered the significant difference at p <0.05, and expected higher reduction in the subjects of experimental groups.;In group 1, 89.5% of subjects presented high levels of oral Candida colonization; in group 2, 70.0% and in placebo group, 70.0%. After 8-week experimental period, the high levels of oral Candida colonization were observed in group 1, 42.0% of subjects; in group 2, 40.0%, and in placebo group, 60.0%. The reduction in the number of subjects infected with high levels, greater than or equal to 3 log CFU/ml, was more pronounced in both experimental groups. However, this reduction was only statistically significant for the group 1 (p< 0.05, Fisher test).

Countries

Brazil

Contacts

Public ContactTatiana Miyazima

Faculdade de Odontologia da Universidade de São Paulo

tatimiyazima@usp.br55 (11) 995467890

Outcome results

None listed

Source: REBEC (via WHO ICTRP)