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

NCT ID: NCT05819281

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2023-12-10

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic blend group

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).

Group Type: EXPERIMENTAL

Probiotic blend

Intervention Type: DIETARY_SUPPLEMENT

(Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 1010 CFU/day).

Placebo group

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

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Interventions

Probiotic blend

(Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 1010 CFU/day).

Intervention Type: DIETARY_SUPPLEMENT

PLACEBO

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

OTHER

Sponsor Role: lead

Responsible Party

Monique Michels

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Do Extremo Sul Catarinense

Criciúma, Santa Catarina, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

MONIQUE MICHELS

Role: primary

monique@biohall.com.br

+55 48 996274651

Other Identifiers

63067022.2.0000.0119

Identifier Type: -

Identifier Source: org_study_id