Irritable Bowel Syndrome With DiarrheaNCT04662957
Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome
A study testing Maltodextrin in people with Irritable Bowel Syndrome With Diarrhea and Effects of Probiotics, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
Trial summary
Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits without any structural abnormalities. Despite extensive research, the pathogenesis of IBS has not been clearly elucidated yet. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea, Effects of Probiotics
- What is being tested?
- Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 2 Nov 2019to 31 May 2020
- Phase
- Interventional
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diarrhea-predominant irritable bowel syndrome (IBS-D)
- at least moderate form of IBS-D assessed using IBS-SSS, i.e. with score >175
- male and female subjects of Caucasian race
- age between 16 and 70 years (inclusive)
- good physical, medical and mental status estimated on the basis of the medical history and a general clinical examination
- results of laboratory tests (hematology, clinical chemistry, serology, and urinalysis) within the normal range of the local laboratory or considered non-clinically significant by the investigator
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- patients who have provided freely their own written informed consent
- patients available for the whole study period
- patients who are able to follow strictly the instructions of the investigational team regarding the study procedures and to fulfil the requirements of the protocol
- the following medications are permitted during the course of the study, as long as they are used at a constant dosage and are commenced at least 1 month prior to study start: birth control pill, or depot intramuscular contraceptive preparation, estrogen-progesterone replacement therapy, L-thyroxine, low-dose antidepressants (up to 25 mg day of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), low-dose antihypertensives in the diuretic, angiotensin-converting enzyme inhibitor or angiotensin II inhibitor classes
- patients are allowed to take spasmolytic drugs on an ad hoc basis
Who cannot join
- other than IBD-D types of IBD
- mild type of IBS-D (<175 points in IBS-SSS scale)
- the use of probiotics within last three months
- the treatment with antibiotics within last three months
- a concurrent severe illness (malignancies, uncontrolled hypertension and diabetes mellitus, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma, chronic obstructive pulmonary disease, hyper- or hypothyroidism)
- chronic bowel disorders other than IBS, including inflammatory bowel diseases, gastroenteritis, stomach and duodenal ulcers, celiac diseases;
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- pregnancy or lactation
- diagnosed lactose intolerance
- the use of motility drugs or dietary fiber supplements within 2 weeks before study start
- plan to have surgery during the time of the study
- a history of alcohol or drug abuse
- taking anti-coagulant medications
- participation in another clinical trial within last three months
- patients who will receive antibiotics during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Multi Strain Probiotic Preparation in Patients With Diarrhea Predominant Irritable Bowel Syndrome - Randomized Double Blide Placebo Controlled Study
Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits without any structural abnormalities. Despite extensive research, the pathogenesis of IBS has not been clearly elucidated yet. Recent studies have shown that disturbed gut microbiota may promote the development and maintenance of IBS. Significant changes in the microbial communities of healthy controls vs IBS patients have been reported in several studies. These findings promoted the research on probiotics for the treatment of IBS. Probiotics are live microorganisms which, when administered at the right dose, have a positive effect on human health. The currently published systemic reviews and meta-analyses of randomized clinical trials have indicated that probiotics have beneficial clinical effects and can help to reduce global and specific IBS symptoms significantly. However, the effect depends on the specific composition of the probiotic preparation, and some meta-analyzes indicate that multi-strain preparations are more effective than single-strain preparations. Therefore, further research is highly anticipated. The purpose of the current clinical trial is to assess the effectiveness of multi-strain probiotic preparation in patients with diarrhea predominant IBS (IBS-D).
- Being tested
- Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placeboDietary supplement
Oral supplementation with multi-strain probiotic preparation
MaltodextrinDietary supplement
Maltodextrin as placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic preparation | Experimental | Multi-strain probiotic mixture. The daily dose was five billion (2 capsules/day). Receives: Dietary Supplement: Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo |
| Maltodextrin | Placebo comparator | Maltodextrin comparable in color, texture and taste to the probiotic mixture (2 capsules/day). Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)
IBS-Severity Scoring System is a 5-question survey that asks: 1. the severity of abdominal pain, 2. frequency of abdominal pain, 3. severity of abdominal distention, 4.dissatisfaction with bowel habit, and 5. interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Each of the five question generates a maximum score of 100 point, and total scores can range from 0-500 with higher scores indicating severe symptoms. A decrease of 30 points is associated with a clinically meaningful improvement.
Measured: From baseline at 4 and 8 weeks of intervention
Improvement or worsening of IBS global symptoms using Global Improvement Scale (IBS-GIS)
IBS-Global Improvement Scale asseses IBS symptoms using a patient-defined 7 point Linkert scale ranging from symptoms substantially worse to substantially improved.
Patients answer the question "Have you felt any change in the severity of your symptoms over the past 7 days compared to how you felt before the medicine was given?
The answers are recorded based on the 7-point scale:
- I feel that the symptoms have worsened significantly
- I feel that the symptoms have moderately worsened
- I feel that the symptoms have slightly worsened
- I feel no change
- I feel a slight improvement
- I feel moderate improvement
- I feel significant improvement
IBS-GIS score indicates: improvement if is >4 or worsening if is<4, no change if is 4
Measured: From baseline at 4 and 8 weeks of intervention
Changes in adequate relief of IBS symptoms (IBS-AR)
IBS-Adequate Relief (IBS-AR) is a dichotomous single item that asks participants "Over the past week (7 days) have you had adequate relief of your IBS symptoms? The answer is YES or NO.
Measured: From baseline at 4 and 8 weeks of intervention
Secondary outcomes (6)
Changes in type of stools
ype of stool assessed before intervention and then 3 times a week. Type of stools assessed using the Bristol Stool Scale. Bristol Scale is designed to classify faeces into seven groups: type 1-2 indicate constipation, type 3-4 are "normal" stools; type 5-7 indicate diarrhea.
Measured: From baseline for 8 weeks of intervention
Changes in number of bowel movements per day
Number of bowel movements per day assessed before intervention and then 3 times a week
Measured: From baseline for 8 weeks of intervention
Changes in severity of pain
The severity of pain assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no pain, and 1-4 the severity of pain with higher scores indicating worse pain
Measured: From baseline for 8 weeks of intervention
Changes in flatulence
The severity of flatulence assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no flatulence, and points1-4 with higher scores indicating worse flatulence
Measured: From baseline for 8 weeks of intervention
Changes in feeling of incomplete evacuation of stool
The severity of incomplete evacuation of stool assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no feeling of incomplete evacuation of stool, and points1-4 with higher scores indicating worse feeling of incomplete evacuation of stool
Measured: From baseline for 8 weeks of intervention
Changes in the occurrence of adverse events
The number and the type of adverse events assessed before intervention and then 3 times a weeks.
Measured: From baseline for 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start2 Nov 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Memorial Health Institute, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Lublin
- Responsible party
- Principal investigator, Bożena Cukrowska, Children's Memorial Health Institute, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662957
- Sponsor's protocol ID
- MBX02/2019/P
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Skrzydlo-Radomanska B, Prozorow-Krol B, Cichoz-Lach H, Majsiak E, Bierla JB, Kanarek E, Sowinska A, Cukrowska B. The Effectiveness and Safety of Multi-Strain Probiotic Preparation in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Controlled Study. Nutrients. 2021 Feb 26;13(3):756. doi: 10.3390/nu13030756.
PubMed 33652763
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Multi Strain Probiotic Preparation in Patients With Diarrhea Predominant Irritable Bowel Syndrome - Randomized Double Blide Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04662957
- Acronym / sponsor ID
- MBX02/2019/P
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Children's Memorial Health Institute, PolandUniversity, hospital or other
- Collaborators
- Medical University of Lublin
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 10 Dec 2020 (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 one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits without any structural abnormalities. Despite extensive research, the pathogenesis of IBS has not been clearly elucidated yet. Recent studies have shown that disturbed gut microbiota may promote the development and maintenance of IBS. Significant changes in the microbial communities of healthy controls vs IBS patients have been reported in several studies. These findings promoted the research on probiotics for the treatment of IBS. Probiotics are live microorganisms which, when administered at the right dose, have a positive effect on human health. The currently published systemic reviews and meta-analyses of randomized clinical trials have indicated that probiotics have beneficial clinical effects and can help to reduce global and specific IBS symptoms significantly. However, the effect depends on the specific composition of the probiotic preparation, and some meta-analyzes indicate that multi-strain preparations are more effective than single-strain preparations. Therefore, further research is highly anticipated. The purpose of the current clinical trial is to assess the effectiveness of multi-strain probiotic preparation in patients with diarrhea predominant IBS (IBS-D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic preparation | Experimental | Dietary Supplement: Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placeboMulti-strain probiotic mixture. The daily dose was five billion (2 capsules/day). |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin comparable in color, texture and taste to the probiotic mixture (2 capsules/day). |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- diarrhea-predominant irritable bowel syndrome (IBS-D)
- at least moderate form of IBS-D assessed using IBS-SSS, i.e. with score >175
- male and female subjects of Caucasian race
- age between 16 and 70 years (inclusive)
- good physical, medical and mental status estimated on the basis of the medical history and a general clinical examination
Key exclusion criteria (14 listed)
- other than IBD-D types of IBD
- mild type of IBS-D (<175 points in IBS-SSS scale)
- the use of probiotics within last three months
- the treatment with antibiotics within last three months
- a concurrent severe illness (malignancies, uncontrolled hypertension and diabetes mellitus, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma, chronic obstructive pulmonary disease, hyper- or hypothyroidism)
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 |
|---|---|---|
| Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placeboOral supplementation with multi-strain probiotic preparation | Dietary supplement | Probiotic preparation |
| MaltodextrinMaltodextrin as placebo | Dietary supplement | Maltodextrin |
Primary outcome
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)
Time frame: From baseline at 4 and 8 weeks of intervention
IBS-Severity Scoring System is a 5-question survey that asks: 1. the severity of abdominal pain, 2. frequency of abdominal pain, 3. severity of abdominal distention, 4.dissatisfaction with bowel habit, and 5. interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale. Each of the five question generates a maximum score of 100 point, and total scores can range from 0-500 with higher scores indicating severe symptoms. A decrease of 30 points is associated with a clinically meaningful improvement.
Improvement or worsening of IBS global symptoms using Global Improvement Scale (IBS-GIS)
Time frame: From baseline at 4 and 8 weeks of intervention
IBS-Global Improvement Scale asseses IBS symptoms using a patient-defined 7 point Linkert scale ranging from symptoms substantially worse to substantially improved. Patients answer the question "Have you felt any change in the severity of your symptoms over the past 7 days compared to how you felt before the medicine was given? The answers are recorded based on the 7-point scale: 1. I feel that the symptoms have worsened significantly 2. I feel that the symptoms have moderately worsened 3. I feel that the symptoms have slightly worsened 4. I feel no change 5. I feel a slight improvement 6. I feel moderate improvement 7. I feel significant improvement IBS-GIS score indicates: improvement if is >4 or worsening if is<4, no change if is 4
Changes in adequate relief of IBS symptoms (IBS-AR)
Time frame: From baseline at 4 and 8 weeks of intervention
IBS-Adequate Relief (IBS-AR) is a dichotomous single item that asks participants "Over the past week (7 days) have you had adequate relief of your IBS symptoms? The answer is YES or NO.
6 secondary outcomes
Changes in type of stools
Time frame: From baseline for 8 weeks of intervention
Changes in number of bowel movements per day
Time frame: From baseline for 8 weeks of intervention
Changes in severity of pain
Time frame: From baseline for 8 weeks of intervention
Changes in flatulence
Time frame: From baseline for 8 weeks of intervention
Changes in feeling of incomplete evacuation of stool
Time frame: From baseline for 8 weeks of intervention
Changes in the occurrence of adverse events
Time frame: From baseline for 8 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Derived from this study: PubMed 33652763Skrzydlo-Radomanska B, Prozorow-Krol B, Cichoz-Lach H, Majsiak E, Bierla JB, Kanarek E, Sowinska A, Cukrowska B. The Effectiveness and Safety of Multi-Strain Probiotic Preparation in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Controlled Study. Nutrients. 2021 Feb 26;13(3):756. doi: 10.3390/nu13030756.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin in people with Irritable Bowel Syndrome With Diarrhea and Effects of Probiotics, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
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 11 inclusion and 14 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: finished, as of the sponsor's last update on 16 Dec 2020. 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 Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS) (time frame: From baseline at 4 and 8 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662957, which also lists 1 linked publication.
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 16 Dec 2020.