The Effect of Probiotics on Functional Constipation in the Elderly

NCT04506801 | Completed

• 1 other identifier: 380-130/134-19-4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Constipation

Keywords

constipation; elderly; probiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in hs-CRP at the blood of a patient who uses probiotics determined by immunoturbidimetric method

  12 weeks

• Change in glucose parameters of a patient who use probiotics determined by standard laboratory methods

  12 weeks

• Change in blood parameters- triglycerides of a patient who use probiotics determined by standard laboratory methods.

  12 weeks

• Change in blood parameter- total cholesterol of a patient determined by standard laboratory methods

  12 weeks

• Change in HDL cholesterol in blood parameters of a patient who use probiotics determined by standard laboratory methods

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

liquid oral formulation 9 drops once a day

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

Dietary Supplement: Probalans senior

Interventions

Probalans senior DIETARY_SUPPLEMENT

Participants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention.

Probiotic

Placebo OTHER

Participants were told to consume 9 drops of study placebo one a day for the next 12-week intervention

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 65 years or more
• signed informed consent for study participation
• functional constipation defined by Rome IV criteria
• ability to understand the procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Katarina Fehir Šola: lead

Study Sites (1)

Katarina Fehir Šola

Bjelovar, 43000, Croatia

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: A randomization list will be generated by the permutated block method (variable size 4-6) and will be kept in a sealed envelope by a person not included in the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of pharmacy

Model Details: randomised double-blind study

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 10, 2020
• Study Start: September 25, 2018
• Primary Completion: March 25, 2019
• Study Completion: May 25, 2019
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

CR (1)