The Effect of Probiotics on Functional Constipation in the Elderly

Functional Constipation Clinical Trial

Official title:

The Effect of Probiotics on Functional Constipation in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506801
• Other study ID #: 380-130/134-19-4
• Status: Completed
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: May 25, 2019

Study information

• Verified date: August 2020
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

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

Locations

Country	Name	City	State
Croatia	Katarina Fehir Šola	Bjelovar

Sponsors (1)

Lead Sponsor	Collaborator
Katarina Fehir Šola

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stool frequency in patients who use probiotics	The proportion of subjects who meet the criterion of "normal bowel movement" according to the Roman IV criteria, at least 3 times a week to no more than 3 times a day. This proportion will be determined for each of the 4 evaluation weeks and will be analyzed as a time-averaged proportion. The proportion will be estimated on the basis of the subjects' diaries in which, by days, with indicated dates, the subjects will record each bowel emptying. Investigators would inform the evidence base with regards to the multi-strained probiotic efficacy in treating constipation among the elderly.	12 weeks
Secondary	Change in hs-CRP at the blood of a patient who uses probiotics determined by immunoturbidimetric method	The secondary outcome is to investigate the effect of selected probiotic strains on the concentration of the marker of inflammation, hs c-reactive protein (hs-CRP) in the serum of the subjects. hs-CRP will be determined by the immunoturbidimetric method. Investigators wanted to study the effect of this multi-strained probiotic on clinical and laboratory parameters. Blood was collected before the probiotic intervention and after 12 weeks.	12 weeks
Secondary	Change in glucose parameters of a patient who use probiotics determined by standard laboratory methods	Values of laboratory indicators - glucose metabolism will be monitored. Investigators wanted to study the effect of this multi-strained probiotic on glucose parameters. Blood was collected like in Outcome2, before the intervention and after the intervention.	12 weeks
Secondary	Change in blood parameters- triglycerides of a patient who use probiotics determined by standard laboratory methods.	Values of laboratory indicators of lipid metabolism - triglycerides will be monitored. Blood was collected before and after the intervention. Investigators wanted to study the effect of multi-strain probiotics on triglycerides.	12 weeks
Secondary	Change in blood parameter- total cholesterol of a patient determined by standard laboratory methods	Investigator monitoring change of laboratory indicators of total cholesterol in beginning and at the end of the intervention with multi-strain probiotics.	12 weeks
Secondary	Change in HDL cholesterol in blood parameters of a patient who use probiotics determined by standard laboratory methods	Values of laboratory indicators of HDL (high density lipoprotein) will be monitoring during the intervention. Blood samples were collected before and after the intervention.	12 weeks
Secondary	Change in LDL cholesterol at the blood of patients who use probiotics determined by standard laboratory methods	Investigator monitoring change of laboratory indicators of LDL(low density lipoprotein), before study and at the end of the intervention.	12 weeks