NCT04506801

The Effect of Probiotics on Functional Constipation in the Elderly

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Katarina Fehir Šola · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The main scope of the proposed research in the framework is to investigate the effect of probiotic bacteria Lactobacillus acidophilus LA3, Bifidobacterium animalis ssp. lactis BLC1 i Lactobacillus casei BGP93 on functional constipation and on the quality of life of the elderly in a nursing home. The experimental part will consists of double-blind, placebo-controlled clinical trial over 12 weeks.

Detailed description

During the first four weeks, the subjects were monitored primarily concerning bowel discharges and general health. After that initial four weeks, they are re-evaluated compliance with inclusion and exclusion criteria. Participants were allocated to the double-blind section of the trial (12 weeks), using o computer-generated to a placebo group or in the probiotic group in the form of a liquid oral formulation once a day. On first day of intervention participants provide a blood sample. All investigators, participants and study personnel were blinded to the order of randomization. Participants were told to consume 9 drops of study probiotics once a day for next 12-week intervention. On last day of intervention, participants provide a blood sample. The last four weeks of the double-blind section (week 9-12) participants an evaluation period in which the respondents were evaluated for the outcomes of the study. After completing the double-blind study, the participants were followed for an additional four weeks. Inclusive / Excluded criteria are evaluated on two occasions, at the time of inclusion in the 4-week introductory section and its end.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probalans senior	Participants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention.
OTHER	Placebo	Participants were told to consume 9 drops of study placebo one a day for the next 12-week intervention

Timeline

• Start date: 2018-09-25
• Primary completion: 2019-03-25
• Completion: 2019-05-25
• First posted: 2020-08-10
• Last updated: 2020-08-10

Locations

1 site across 1 country: Croatia