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

Effects of Probiotic Supplementation on Intestinal Function in adult women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5hnk3r
Enrollment
Unknown
Registered
2017-08-24
Start date
2016-11-01
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

Intestinal Constipation

Interventions

The volunteers will be divided into 2 groups. Experimental group: 105 women will receive 15 sachets containing probiotic powder and will be given once daily diluted in water for 15 days. Placebo group
Dietary supplement
SP6.051.227
G07.203.300.456.500

Sponsors

Universidade Federal de Mato Grosso
Lead Sponsor
Vitafor©
Collaborator

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Brazil

Contacts

Public ContactCarlos;Carolina Fett;Novaes

NAFIMES Núcleo de Aptidão Física, Informática, Metabolismo, Esporte e Saúde;Vitafor©

fettcarlos@gmail.com;rt@vitafor.com.br+55 (65) 3615 8833;+55 (15) 3291 8090

Outcome results

None listed

Source: REBEC (via WHO ICTRP)