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Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic blend
PLACEBO
Sponsored by
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Provision of Free and Informed Consent in writing, signed and dated; Age according to the indicated population; Patients diagnosed with IBS by a specialist. Exclusion Criteria: Individuals with a history of daily consumption of probiotics, fermented milk and / or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product; Individuals who have unbalanced blood pressure; hx of heart disease, including valvulopathies or any implantable device; individuals on immunosuppressive therapy or any health condition causing immunosuppression; individuals with active, uncontrolled bowel disease such as Crohn's disease or ulcerative colitis; Women who are pregnant at the time of enrollment or who plan to become pregnant during the study; Individuals with concomitant participation in another clinical trial; History of autoimmune disease.

Sites / Locations

  • Universidade Do Extremo Sul CatarinenseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic blend group

Placebo group

Arm Description

Volunteers supplemented with the probiotic product (n=57) (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 10e10 CFU/day).

Placebo Group (n=57): Volunteers supplemented with placebo (maltodextrin)

Outcomes

Primary Outcome Measures

Bristol scale
The Bristol Stool Form Scale is used for describing feces into seven categories. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea. People with irritable bowel syndrome (IBS) typically report that they suffer with abdominal cramps and constipation. In some patients, chronic constipation is interspersed with brief episodes of diarrhoea; while a minority of patients with IBS have only diarrhoea.

Secondary Outcome Measures

Change of quality of life (SF-36 scale)
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. It comprises 36 questions that cover eight domains of health
Change of mental health - depression
The Beck Depression Scale or Beck Depression Inventory (BDI, BDI-II), consists of a self-report questionnaire with 21 multiple-choice items. It is one of the most used instruments to measure the severity of depressive episodes. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Gastrointestinal Symptom Rating Scale (GSRS)
The GSRS is a disease-specific instrument. The 15 items combine into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The reliability and validity of the GSRS are well-documented, and norm values for a general population are available. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Change of mental health - anxiety
The State-Trait Anxiety Inventory (STAI) is one of the most used instruments to quantify subjective components related to anxiety. It consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety.

Full Information

First Posted
February 9, 2023
Last Updated
April 14, 2023
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
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1. Study Identification

Unique Protocol Identification Number
NCT05819281
Brief Title
Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome
Official Title
Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms and Improve Quality of Life in Patients Diagnosed With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Irritable bowel syndrome (IBS) is a recurrent, functional disorder characterized by abdominal pain and discomfort, changes in bowel habits and gastrointestinal symptoms such as distension and sensation of abdominal inflammation, incomplete evacuation, urgency and tenesmus. In addition to gastrointestinal symptoms, patients with IBS often experience a wide range of other problems, such as non-abdominal pain, psychological symptoms, poor quality of life, and difficulties in carrying out activities of daily living. Studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of IBS. Our objective is to develop a probiotic product (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus) is safe and effective in reducing symptoms caused by IBS, as well as improving quality of life. In the present study, 114 volunteers of both genders will be included, randomly distributed into two groups: Test group (n=57): Volunteers supplemented with the probiotic product (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus- Final concentration: 1 x 1010 CFU/day). Placebo Group (n=57): Volunteers supplemented with placebo. The study will last 90 days and will have 3 visits to apply the proposed questionnaires.
Detailed Description
Irritable bowel syndrome (IBS) is a recurrent, functional disorder characterized by abdominal pain and discomfort, changes in bowel habits and gastrointestinal symptoms such as distension and sensation of abdominal inflammation, incomplete evacuation, urgency and tenesmus. This disorder affects men and women of all age groups, with a worldwide prevalence of 10% to 20%. In addition to gastrointestinal symptoms, patients with IBS often experience a wide range of other problems, such as non-abdominal pain, psychological symptoms, poor quality of life, and difficulties in carrying out activities of daily living. Treatment is usually symptomatic and associated with changes in lifestyle and diet, drug and psychological treatments and the use of probiotics. Studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of IBS. Furthermore, certain compositions of specific probiotics are found to have benefits, especially in quality of life, bloating and abdominal pain. The hypothesis is that the use of a probiotic blend can reduce gastrointestinal symptoms and improve quality of life through its immunomodulatory and intestinal regulation mechanisms in patients with IBS aim: To develop a safe and effective probiotic product (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus) to reduce the symptoms caused by IBS. METHODS Randomized, double-blind, placebo-controlled study to evaluate the effectiveness of a probiotic blend (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus) in improving symptoms caused by Bowel Syndrome Irritable (IBS). Study will be conducted with patients diagnosed with IBS by the gastroenterologist participating in the study, being an adult audience (18 - 65 years old). In the present study, 114 volunteers of both sexes will be included, randomly distributed into two groups: Test group (n=57): Volunteers supplemented with the probiotic product (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 1010 CFU/day). Placebo Group (n=57): Volunteers supplemented with placebo. The study will last for 90 days. During the trial period, participants must attend the Research Center for the following visits: Visit 1 (day 0) - Evaluation of inclusion and exclusion criteria, clinical and physical evaluation, presentation of the research and signing of the Free and Informed Consent Form in writing, partial delivery of the test product or placebo, delivery and application of questionnaires (questionnaires quality of life (by the SF-36 scale); Bristol scale, Gastrointestinal Symptom Rating Scale (GSRS) questionnaire for gastrointestinal evaluation and mental health questionnaire (BDI and IDATE questionnaire). The questionnaires will be applied preferably in person by the researchers involved (with scheduled time) in interview format or online via Google Forms form, providing confidentiality to all information collected. In addition, the first visit also An explanation will be given regarding the importance of the questionnaires, correct completion, and possible changes in the TGI in the first days of using the probiotic. Visit 2 (day 45) - Clinical consultation with a specialist physician, final delivery of the test product or placebo, and application of questionnaires. Visit 3 (day 90) - Clinical consultation with a specialist physician and final application of questionnaires. Closure of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic blend group
Arm Type
Experimental
Arm Description
Volunteers supplemented with the probiotic product (n=57) (Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 10e10 CFU/day).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo Group (n=57): Volunteers supplemented with placebo (maltodextrin)
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic blend
Intervention Description
(Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 1010 CFU/day).
Intervention Type
Dietary Supplement
Intervention Name(s)
PLACEBO
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
Bristol scale
Description
The Bristol Stool Form Scale is used for describing feces into seven categories. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea. People with irritable bowel syndrome (IBS) typically report that they suffer with abdominal cramps and constipation. In some patients, chronic constipation is interspersed with brief episodes of diarrhoea; while a minority of patients with IBS have only diarrhoea.
Time Frame
Three times (0, 45 and 90 days after inclusion)
Secondary Outcome Measure Information:
Title
Change of quality of life (SF-36 scale)
Description
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. It comprises 36 questions that cover eight domains of health
Time Frame
Three times (0, 45 and 90 days after inclusion)
Title
Change of mental health - depression
Description
The Beck Depression Scale or Beck Depression Inventory (BDI, BDI-II), consists of a self-report questionnaire with 21 multiple-choice items. It is one of the most used instruments to measure the severity of depressive episodes. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time Frame
Three times (0, 45 and 90 days after inclusion)
Title
Gastrointestinal Symptom Rating Scale (GSRS)
Description
The GSRS is a disease-specific instrument. The 15 items combine into five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The reliability and validity of the GSRS are well-documented, and norm values for a general population are available. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Time Frame
Three times (0, 45 and 90 days after inclusion)
Title
Change of mental health - anxiety
Description
The State-Trait Anxiety Inventory (STAI) is one of the most used instruments to quantify subjective components related to anxiety. It consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety.
Time Frame
Three times (0, 45 and 90 days after inclusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of Free and Informed Consent in writing, signed and dated; Age according to the indicated population; Patients diagnosed with IBS by a specialist. Exclusion Criteria: Individuals with a history of daily consumption of probiotics, fermented milk and / or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product; Individuals who have unbalanced blood pressure; hx of heart disease, including valvulopathies or any implantable device; individuals on immunosuppressive therapy or any health condition causing immunosuppression; individuals with active, uncontrolled bowel disease such as Crohn's disease or ulcerative colitis; Women who are pregnant at the time of enrollment or who plan to become pregnant during the study; Individuals with concomitant participation in another clinical trial; History of autoimmune disease.
Facility Information:
Facility Name
Universidade Do Extremo Sul Catarinense
City
Criciúma
State/Province
Santa Catarina
ZIP/Postal Code
88806000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MONIQUE MICHELS
Phone
+55 48 996274651
Email
monique@biohall.com.br

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome

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