The Effect of Probiotics on Functional Constipation in the Elderly

Katarina Fehir Šola

Status: Completed

Conditions: Functional Constipation

Treatments: Other: Placebo; Dietary Supplement: Probalans senior

Study type: Interventional

Funder types: Other

Identifiers

NCT04506801

380-130/134-19-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

liquid oral formulation 9 drops once a day

Treatment:

Other: Placebo

Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probalans senior