Irritable Bowel SyndromePhase 2NCT05819281
Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome
A Phase 2 study testing Probiotic blend in people with Irritable Bowel Syndrome, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Probiotic blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Mar 2023to 10 Dec 2023
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of Free and Informed Consent in writing, signed and dated;
- Age according to the indicated population;
- Patients diagnosed with IBS by a specialist.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Do Extremo Sul Catarinense
Criciúma, Santa Catarina, 88806000
MONIQUE MICHELS, +55 48 996274651, monique@biohall.com.br
About this study
Official title: Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms and Improve Quality of Life in Patients Diagnosed With Irritable Bowel Syndrome
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.
Read the 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
- Being tested
- Probiotic blend, PLACEBO
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic blendDietary supplement
(Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 1010 CFU/day).
PLACEBODietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Probiotic blend group | Experimental | 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). Receives: Dietary Supplement: Probiotic blend |
| Placebo group | Placebo comparator | Placebo Group (n=57): Volunteers supplemented with placebo (maltodextrin) Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three times (0, 45 and 90 days after inclusion)
Secondary outcomes (4)
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
Measured: Three times (0, 45 and 90 days after inclusion)
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.
Measured: Three times (0, 45 and 90 days after inclusion)
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.
Measured: Three times (0, 45 and 90 days after inclusion)
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.
Measured: Three times (0, 45 and 90 days after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start15 Mar 2023
- Primary completion15 Mar 2023
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique Michels, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819281
- Sponsor's protocol ID
- 63067022.2.0000.0119
- Status last verified
- Apr 2023
- First submitted
- 9 Feb 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms and Improve Quality of Life in Patients Diagnosed With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05819281
- Acronym / sponsor ID
- 63067022.2.0000.0119
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 19 Apr 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic blend group | Experimental | Dietary Supplement: Probiotic blendVolunteers 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 | Placebo comparator | Dietary Supplement: PLACEBOPlacebo Group (n=57): Volunteers supplemented with placebo (maltodextrin) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of Free and Informed Consent in writing, signed and dated;
- Age according to the indicated population;
- Patients diagnosed with IBS by a specialist.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Probiotic blend(Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium bifidum e Lactobacillus rhamnosus - Final concentration: 1 x 1010 CFU/day). | Dietary supplement | Probiotic blend group |
| PLACEBOMaltodextrin | Dietary supplement | Placebo group |
Primary outcome
Bristol scale
Time frame: Three times (0, 45 and 90 days after inclusion)
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.
4 secondary outcomes
Change of quality of life (SF-36 scale)
Time frame: Three times (0, 45 and 90 days after inclusion)
Change of mental health - depression
Time frame: Three times (0, 45 and 90 days after inclusion)
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Three times (0, 45 and 90 days after inclusion)
Change of mental health - anxiety
Time frame: Three times (0, 45 and 90 days after inclusion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic blend in people with Irritable Bowel Syndrome, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bristol scale (time frame: Three times (0, 45 and 90 days after inclusion)). 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 19 Apr 2023.