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NOT YET RECRUITING
NCT06432608
NA

Efficacy of Lacticaseibacillus Paracasei Strain Shirota on Clinical Manifestation of Functional Constipation in Mexican Adults

Sponsor: University of Guadalajara

View on ClinicalTrials.gov

Summary

Chronic functional constipation is a gastrointestinal disorder with an approximate prevalence of 14% of the Mexican population, which is characterized by difficult or incomplete defecation and/or infrequent bowel movements, with the absence of symptoms such as abdominal pain or inflammation, and in If they occur, they should not be the predominant symptoms. Its origin is multifactorial and includes variables such as diet, water consumption, alteration in motility, and intestinal microbiota, the latter as a source of different secondary metabolites such as short-chain fatty acids (SCFAs). Lower SCFA values in constipation would alter the relationship between them, increasing the risk of clinical manifestations of functional chronic constipation. In addition to physical discomfort, subjects with this disease manifest alterations in their quality of life. Recent studies have suggested using probiotic microorganisms to treat this functional disorder due to their beneficial effects on evacuation frequency, SCFAs, and quality of life. However, in Mexico, knowledge of the above is limited. Therefore, this research aims to determine the effect of consuming a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota on the clinical manifestations of functional constipation in Mexican adults and its relationship with SCFAs.

Official title: Single Arm Study to Evaluate the Efficacy of Lacticaseibacillus Paracasei Strain Shirota (Formerly Lactobacillus Casei Strain Shirota) Fermented Milk (Yakult®) on the Maintenance of Clinical Manifestations of Functional Constipation in Mexican Adults

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-06-15

Completion Date

2025-11-25

Last Updated

2024-05-29

Healthy Volunteers

No

Conditions

Interventions

DIETARY_SUPPLEMENT

fermented milk, Yakult

Study subjects will be provided with a product based on fermented milk, Yakult (80mL) daily for four weeks in order to know the effects of clinical manifestation of functional constipation and short-fatty acids in the Mexican population