IBS - Irritable Bowel SyndromePhase 4NCT05509725
Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)
A Phase 4 study testing Probiotic formulation in people with IBS - Irritable Bowel Syndrome, run by Lallemand Health Solutions at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Probiotic formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2022to Nov 2024
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Experiencing symptoms of IBS-D
- Having a diagnosis of IBS-D based on Rome IV criteria
- Participants with symptom onset at least 6 months before diagnosis
- Having a normal colonoscopy result in their medical file
Who cannot join
- A history of inflammatory or immune-mediated gastrointestinal diseases
- Diagnosed with a co-existing organic gastrointestinal disease which can affect the study
- Currently undergoing a treatment for other severe conditions such as coronary disease, neurological disorder, kidney or liver disease,
- Currently diagnosed with an eating disorder,
- Having undergone any abdominal surgery including cholecystectomy, with the exception of hernia repair or appendectomy
- Currently diagnosed with any mood- or anxiety-related disorder, major psychiatric illness, or participants with a history of suicidal ideation, or current suicidal ideation,
Show all 9Show fewer
- Regular use of anti-diarrhea medications and laxatives however occasional use is permitted (≤ than once a month); if current use is > once per month a one month wash out is needed,
- Unwilling to avoid the use of antidiarrheal or laxative medication on an "as-needed basis" during the full length of the study,
- Pregnant, breast-feeding or planning on becoming pregnant.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University Faculty of Medicine, Gastroenterology Department
Izmir, 35040
About this study
Official title: Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D): A Multicenter, Randomized, Prospective, Placebo-Controlled, Double-Blind, Phase IV Clinical Study
The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.
Read the detailed description
To monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with IBS-D.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Probiotic formulation, Placebo
- Keywords
- IBS-D, Probiotics
- 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 formulationDrug
Participants will be asked to take 2 doses daily
PlaceboDrug
Participants will be asked to take 2 doses daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks. Receives: Drug: Probiotic formulation |
| Control | Placebo comparator | Participants in this group will be randomized to receive placebo for the following 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Abdominal Pain
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Measured: 8 weeks
Change in Defecation consistency
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
Measured: 8 weeks
Secondary outcomes (6)
Change Abdominal pain intensity
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Measured: up to 10 weeks
Abnormal defecation consistency
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
Measured: up to 10 weeks
Stool frequency
Measured as the average number of stools per week
Measured: up to 10 weeks
Abdominal discomfort
Using questionnaire in participants diary
Measured: up to 10 weeks
Perceived Stress
Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress)
Measured: 8 weeks
Change in Irritable Bowel Syndrome Symptom Severity Scores
Using the The irritable bowel severity scoring system (IBS-SSS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start11 Aug 2022
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Serhat Bor, Prof. Dr., Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509725
- Sponsor's protocol ID
- C-005
- Status last verified
- Feb 2024
- First submitted
- 1 Jul 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D): A Multicenter, Randomized, Prospective, Placebo-Controlled, Double-Blind, Phase IV Clinical Study
- ClinicalTrials.gov ID
- NCT05509725
- Acronym / sponsor ID
- C-005
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- IBS-D, Probiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 22 Aug 2022 (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 purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.
Detailed description
To monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with IBS-D.
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 |
|---|---|---|
| Intervention | Experimental | Drug: Probiotic formulationParticipants in this group will be randomized to receive probiotic formulation for the following 8 weeks. |
| Control | Placebo comparator | Drug: PlaceboParticipants in this group will be randomized to receive placebo for the following 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experiencing symptoms of IBS-D
- Having a diagnosis of IBS-D based on Rome IV criteria
- Participants with symptom onset at least 6 months before diagnosis
- Having a normal colonoscopy result in their medical file
Key exclusion criteria (9 listed)
- A history of inflammatory or immune-mediated gastrointestinal diseases
- Diagnosed with a co-existing organic gastrointestinal disease which can affect the study
- Currently undergoing a treatment for other severe conditions such as coronary disease, neurological disorder, kidney or liver disease,
- Currently diagnosed with an eating disorder,
- Having undergone any abdominal surgery including cholecystectomy, with the exception of hernia repair or appendectomy
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 formulationParticipants will be asked to take 2 doses daily | Drug | Intervention |
| PlaceboParticipants will be asked to take 2 doses daily | Drug | Control |
Primary outcome
Change in Abdominal Pain
Time frame: 8 weeks
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Change in Defecation consistency
Time frame: 8 weeks
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
6 secondary outcomes
Change Abdominal pain intensity
Time frame: up to 10 weeks
Abnormal defecation consistency
Time frame: up to 10 weeks
Stool frequency
Time frame: up to 10 weeks
Abdominal discomfort
Time frame: up to 10 weeks
Perceived Stress
Time frame: 8 weeks
Change in Irritable Bowel Syndrome Symptom Severity Scores
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No. After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Related trials for IBS - Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Serhat Bor, Prof. Dr. principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotic formulation in people with IBS - Irritable Bowel Syndrome, run by Lallemand Health Solutions at 1 site in Turkey (Türkiye).
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 9 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 20 Feb 2024. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Burcu Sume (+90 312 479 88 75, burcus@croturk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Abdominal Pain (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 20 Feb 2024.