The Effect of Probiotics on Functional Constipation in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-25

Study Completion Date

2019-05-25

Brief Summary

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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.

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Detailed Description

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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

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised double-blind study

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

A randomization list will be generated by the permutated block method (variable size 4-6) and will be kept in a sealed envelope by a person not included in the study.

Study Groups

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Placebo

liquid oral formulation 9 drops once a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants were told to consume 9 drops of study placebo one a day for the next 12-week intervention

Probiotic

The probiotic contained Lactobacillus acidophilus LA3; 1 · 1011 CFU / g, Bifidobacterium animalis subsp. Lactis BLC1; 1.5 · 1011 CFU / g and Lactobacillus casei BGP93 2 · 1011cfu / g in the form of a liquid oral formulation

Group Type EXPERIMENTAL

Probalans senior

Intervention Type DIETARY_SUPPLEMENT

Participants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention.

Interventions

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Probalans senior

Participants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants were told to consume 9 drops of study placebo one a day for the next 12-week intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 65 years or more
* signed informed consent for study participation
* functional constipation defined by Rome IV criteria
* ability to understand the procedure

Exclusion Criteria

* suspicion of obstructive ileus or previous obstructive ileus
* suspected or confirmed diagnosis: irritable colon syndrome, ulcerative colitis, Crohn's disease, malignant digestive tract disease
* diarrhoea of any cause within the last month
* acute infectious disease within the last month excluding people who use antibiotics
* persons who have opioid analgesics in pharmacotherapy

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes