Effects of Probiotic Supplementation versus Placebo on Intestinal Function in adult wome

Not Applicable

Recruiting

• Conditions: Intestinal Constipation; Women; C23.888.821.150; M01.975

• Registration Number: RBR-5hnk3r
• Lead Sponsor: niversidade Federal de Mato Grosso

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women between the ages of 20 and 40; who are classified as constipated according to the ROME III criteria are;
Maintain the same diet and routine of daily activities; and sign the Informed Consent Term.

Exclusion Criteria

Not to be classified as constipated according to the criteria of ROME III; Not sign the Free and Informed Consent Form; Abstain from treatment for one day; To change their eating routine or exercise during the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected that after the use of probiotics the volunteers will have an improvement in intestinal function that will be evaluated through the ROMA III and CAS questionnaires at the beginning and end of the 15-day intervention. The data collected through applied questionnaires will be submitted to statistical analysis with a variation of at least 5% in the pre and post intervention measurements, and the expected intestinal constipation reduction in the experimental groups (sachet with probiotics) as compared to the control group (sachet placebo).

Secondary Outcome Measures

Name	Time	Method
It is expected that after the use of probiotics the volunteers will have an improvement in the quality of life that will be evaluated through the PAC-QOL questionnaire at the beginning and end of the 15-day intervention. The data collected through this questionnaire will be submitted to statistical analysis with a variation of at least 5% in the pre and post intervention measurements, and the expected quality of life improvement in the experimental groups (sachet with probiotics) as compared to the control group ( Placebo sachet).