Clinical trial NCT04506801: The Effect of Probiotics on Functional Constipation in the Elderly
Official title: The Effect of Probiotics on Functional Constipation in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Keywords: constipation
elderly
probiotics
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised double-blind study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in stool frequency in patients who use probiotics
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in hs-CRP at the blood of a patient who uses probiotics determined by immunoturbidimetric method
timeFrame: 12 weeks
measure: Change in glucose parameters of a patient who use probiotics determined by standard laboratory methods
timeFrame: 12 weeks
measure: Change in blood parameters- triglycerides of a patient who use probiotics determined by standard laboratory methods.
timeFrame: 12 weeks
measure: Change in blood parameter- total cholesterol of a patient determined by standard laboratory methods
timeFrame: 12 weeks
measure: Change in HDL cholesterol in blood parameters of a patient who use probiotics determined by standard laboratory methods
timeFrame: 12 weeks
measure: Change in LDL cholesterol at the blood of patients who use probiotics determined by standard laboratory methods
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bjelovar
country: Croatia
facility: Katarina Fehir Šola
Study officials:
References: