An interventional study of Probalans senior and Placebo in Functional Constipation, sponsored by Katarina Fehir Šola. Completed at 1 site in Croatia. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-10.
Sponsored by Katarina Fehir Šola · Not applicable, Interventional, and Health services research
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.
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →This is the only study on the registry with Katarina Fehir Šola as lead sponsor.
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Exclusion Criteria:
liquid oral formulation 9 drops once a day
Other: Placebo
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
Dietary Supplement: Probalans senior
Participants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention.
Participants were told to consume 9 drops of study placebo one a day for the next 12-week intervention
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Plan to share: Yes — all IPD that underlie results in a publication
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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