Functional ConstipationNCT04506801
The Effect of Probiotics on Functional Constipation in the Elderly
A study testing Probalans senior in people with Functional Constipation, run by Katarina Fehir Šola at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Probalans senior
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 25 Sep 2018to 25 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 65 years or more
- signed informed consent for study participation
- functional constipation defined by Rome IV criteria
- ability to understand the procedure
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Functional Constipation
- Being tested
- Probalans senior, Placebo
- Keywords
- constipation, elderly, probiotics
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probalans seniorDietary supplement
Participants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention.
PlaceboOther
Participants were told to consume 9 drops of study placebo one a day for the next 12-week intervention
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | liquid oral formulation 9 drops once a day Receives: Other: Placebo |
| Probiotic | Experimental | 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 Receives: Dietary Supplement: Probalans senior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start25 Sep 2018
- Primary completion25 Mar 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised double-blind study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katarina Fehir Šola
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katarina Fehir Šola, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506801
- Sponsor's protocol ID
- 380-130/134-19-4
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Functional Constipation in the Elderly
- ClinicalTrials.gov ID
- NCT04506801
- Acronym / sponsor ID
- 380-130/134-19-4
- Conditions
- Functional Constipation
- Keywords
- constipation, elderly, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Katarina Fehir ŠolaUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- randomised double-blind study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placeboliquid oral formulation 9 drops once a day |
| Probiotic | Experimental | Dietary Supplement: Probalans seniorThe 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 65 years or more
- signed informed consent for study participation
- functional constipation defined by Rome IV criteria
- ability to understand the procedure
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probalans seniorParticipants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention. | Dietary supplement | Probiotic |
| PlaceboParticipants were told to consume 9 drops of study placebo one a day for the next 12-week intervention | Other | Placebo |
Primary outcome
Change in stool frequency in patients who use probiotics
Time frame: 12 weeks
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.
6 secondary outcomes
Change in hs-CRP at the blood of a patient who uses probiotics determined by immunoturbidimetric method
Time frame: 12 weeks
Change in glucose parameters of a patient who use probiotics determined by standard laboratory methods
Time frame: 12 weeks
Change in blood parameters- triglycerides of a patient who use probiotics determined by standard laboratory methods.
Time frame: 12 weeks
Change in blood parameter- total cholesterol of a patient determined by standard laboratory methods
Time frame: 12 weeks
Change in HDL cholesterol in blood parameters of a patient who use probiotics determined by standard laboratory methods
Time frame: 12 weeks
Change in LDL cholesterol at the blood of patients who use probiotics determined by standard laboratory methods
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probalans senior in people with Functional Constipation, run by Katarina Fehir Šola at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool frequency in patients who use probiotics (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.