Irritable Bowel SyndromeIBS-PlusNCT05013060
The Efficacy of Sodium Butyrate and Probiotics in Patients With Irritable Bowel Syndrome
A study testing Probiotics and microcapsulated sodium butyrate and Maltodextrin in people with Irritable Bowel Syndrome, run by Nordic Biotic Sp. z o.o. at 1 site in Poland.
Trial summary
According to current IBS management guidelines, probiotic administration reduces IBS-associated symptoms and improves the quality of life. The purpose of this study is to assess the effects of the combined formulation comprising microencapsulated sodium butyrate and a probiotic mixture of two Lactobacillus strains (L. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Probiotics and microcapsulated sodium butyrate and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 15 Apr 2021to 31 Jan 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged from 18 to 70 years, inclusive;
- Good physical and mental condition assessed based on the patient's history and physical examination;
- Laboratory test results (complete blood count, blood chemistry panel) within normal limits or considered not to be clinically significant by the Investigator; negative SARS-CoV-2 antibody test;
- A voluntarily provided written informed consent;
- Diagnosis of IBS based on the Rome IV criteria, e.g. recurrent abdominal pain at least one day a week for the last three months, associated with two or more of the following symptoms (these should be present for the last three months, with the onset of symptoms six months before diagnosis):
- related to defecation
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- associated with a change in stool frequency and/or
- associated with a change in stool form (appearance)
- Patients with any of the following forms of IBS will be included:
- IBS-D - more than 25% of BSF type 6 and 7 stools, and less than 25% of type 1 and 2 stools.
- IBS-C - more than 25% of BSF type 1 and 2 stools, with less than 25% of type 6 and 7 stools.
- IBS-M - more than 25% of BSF type 6 and 7 stools and also more than 25% of type 1 and 2 stools.
- at least moderate symptom severity defined as an IBS-SSS score of >175 (5 items, maximum score 500).
- The following medications are allowed during this study, provided they have been used at a stable dose and for at least 1 month prior to the study:
- contraceptive pills or intramuscular contraceptives,
- hormone replacement therapy (estrogen/progesterone),
- L-thyroxine,
- antidepressants at low doses (up to 25 mg of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor per day)
- antihypertensives at low doses (diuretics, angiotensin converting enzyme inhibitors angiotensin receptor antagonists).
Who cannot join
- Unclassified IBS;
- Cardiovascular disorders: uncontrolled hypertension (blood pressure >170/100 mmHg), cerebrovascular disease;
- Respiratory disorders (asthma, chronic obstructive pulmonary disease [COPD]).
- Hepatic impairment (including status post cholecystectomy), renal impairment, and unexplained blood biochemistry abnormalities: serum creatinine levels over twice the upper limit of normal, AST or ALT levels over twice the upper limit of normal.
- Gastrointestinal conditions other than IBS, including clinical or endoscopic diagnosis of gastroenteritis.
- Endocrine disorders, including diabetes mellitus (fasting blood glucose >11 mmol/L) and elevated TSH levels.
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- Severe neurological conditions, with psychosis;
- Malignancy;
- Pregnancy or breastfeeding;
- Hypersensitivity to soy;
- Lactose intolerance;
- The use of gastrointestinal motility stimulants or dietary fiber supplements during the 2 weeks preceding the clinical study;
- The use of antithrombotic drugs;
- A surgical procedure scheduled during the course of the clinical study;
- Current probiotic use and refusal to undergo a 3-month washout period;
- Antibiotic therapy during the 3 months preceding the study;
- Antibiotic use during the study;
- Being included in another clinical study during the previous 3 months;
- History of alcohol or substance;
- Inability to strictly adhere to the Investigators' instructions regarding study procedures and protocol requirements.abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Assessment of the Efficacy of Microencapsulated Sodium Butyrate and a Probiotic Mixture in Patients With Irritable Bowel Syndrome - a Randomized Double-blind Placebo-controlled Study
According to current IBS management guidelines, probiotic administration reduces IBS-associated symptoms and improves the quality of life. The purpose of this study is to assess the effects of the combined formulation comprising microencapsulated sodium butyrate and a probiotic mixture of two Lactobacillus strains (L. rhamnosus and L. acidophilus) and three Bifidobacterium strains (B. longum, B. bifidum, and B. lactis) on the incidence and severity of clinical symptoms in patients diagnosed with irritable bowel syndrome (IBS) based on the Rome IV criteria.
Microencapsulated sodium butyrate is a short-chain fatty acid (SCFA) with biological effects on the gastrointestinal mucosa; it constitutes a key source of energy for enterocytes. Butyrate was shown to have a trophic effect on the colon epithelium and to help restore the disrupted structural and functional integrity of the gastrointestinal tract. These unique properties of sodium butyrate result in its beneficial effects on the abdominal symptoms (such as diarrhea, constipation, abdominal pain) in patients with IBS. This study will assess the effects of the mixture of sodium butyrate and multi-strain probiotic on the rate and severity of clinical symptoms in IBS patients, by taking into account their nutritional status and body composition.
Read the detailed description
The study schedule includes five visits:the screening/baseline visit, whose purpose is to qualify patients to be included in the study, the randomization visit (visit 0), at which patients will be given a probiotic/butyric acid or placebo, and three follow-up visits (at weeks 4, 8, and 12 after randomization).
All patients will undergo:
- A physical examination - at each visit;
- Nutritional status assessment - at visit 0 and at weeks 4 and 12 of treatment;
- Anthropometric measurements - at visit 0 and at weeks 4 and 12 of treatment;
- Body composition analysis via bioelectrical impedance analysis (BIA) with the use of a Bodystat machine - at visit 0 and at 4 and 12 weeks of treatment;
- Laboratory tests (including complete blood count; liver function tests; bilirubin, amylase, creatinine, CRP, and glucose levels; electrolytes; and an SARS-CoV2 antigen cassette test conducted by a doctor) at the screening visit; and cytokines (IL-6 and macrophage inflammatory protein 1β (MIP-1ß)) at visit 0 and at weeks 4 and 12 of treatment;
- Disease severity will be rated with the IBS symptom severity score (IBS-SSS) developed by Francis, Morris, and Whorwell, with mild, moderate, and severe cases indicated by scores of <175, 175-300, and >300, respectively. In addition, the following scales will be used to assess IBS treatment efficacy: IBS-Quality of Life (IBS-QOL), IBS-Global Improvement Scale (IBS-GIS), and IBS - Adequate Relief (IBS-AR).
- The number and type of bowel movements will be assessed with the Bristol Stool Formation scale.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Probiotics and microcapsulated sodium butyrate, Maltodextrin
- Keywords
- Probiotics, Butyric acid, Microencapsulated sodium butyrate
- 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.
Probiotics and microcapsulated sodium butyrateDietary supplement
The patients who give their consent to take part in this study, will receive an oral microencapsulated sodium butyrate and a mixture of probiotics formulation 2 times a day for a period of 12 weeks.
MaltodextrinDietary supplement
The patients who give their consent to take part in this study will receive an oral maltodextrin as placebo 2 times a day for a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The mixture of probiotics and microcapsulated sodium butyrate | Active comparator | One billion of the following strains: Bifidobacterium lactis FloraActive 32269, Bifidobacterium longum FloraActive 32946, Bifidobacterium bifidum FloraActive 32043, Lactobacillus rhamnosus FloraActive 19070-2, Lactobacillus acidophilus FloraActive 32418 and 150 mg microcapsulated sodium butyrate, and 64 mg fructooligosaccharides Receives: Dietary Supplement: Probiotics and microcapsulated sodium butyrate |
| Placebo | Placebo comparator | Maltodextrin 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-SSS 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.
Measured: Severity of symptoms from baseline at 4, 8 and 12 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: Improvement/worsening assessed after 4, 8 and 12 weeks of intervention
Changes in an adequate relief
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: Adequate Relief after 4, 8 and 12 weeks of interventions
Changes in Quality of Life
The IBS-Quality of Life (IBS-QOL) is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale, thus yielding a total score that has a theoretical range of 34 to 170, with higher scores indicating worse QOL.
Measured: Quality of Life from baseline at 4, 8 and 12 weeks of intervention
Secondary outcomes (5)
Changes in number and type of stools
Number of stools per day and type of stools assessed before intervention and then 3 times a week. Type of stools assessed using the Bristol Stool Formation 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 12 weeks of intervention in 1 week intervals
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 12 weeks of intervention in 1 week intervals
Changes in flatulence/abdominal distension
The severity of flatulence/abdominal distension assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no flatulence/abdominal distension, and 1-4 the severity of flatulence/abdominal distension with higher scores indicating worse flatulence/abdominal distension.
Measured: From baseline for 12 weeks of intervention in 1 week intervals
Changes in Body Mass Index (BMI)
The effect of intervention on the patient's weight
Measured: From baseline at 4 and 12 weeks of intervention
Body composition analysis
Body composition will be measured via bioelectrical impedance analysis with the use of a Bodystat machine.
Measured: From baseline at 4 and 12 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 posted19 Aug 2021
- Study start15 Apr 2021
- Primary completion30 Sep 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Biotic Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Lodz
- Responsible party
- Principal investigator, Anita Gąsiorowska, Nordic Biotic Sp. z o.o.
- Investigators
- Anita Gąsiorowska, MD, PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013060
- Sponsor's protocol ID
- CT/NB/110/2019/PR-MS-PS
- Acronym
- IBS-Plus
- Status last verified
- Feb 2024
- First submitted
- 13 Aug 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee CC, Kono T, Syed F, Weaver SA, Sohn P, Wu W, Chang G, Liu J, Slak Rupnik M, Evans-Molina C. Sodium butyrate prevents cytokine-induced beta-cell dysfunction through restoration of stromal interaction molecule 1 expression and activation of store-operated calcium entry. FASEB J. 2024 Aug 15;38(15):e23853. doi: 10.1096/fj.202302501RR.
PubMed 39120544Gasiorowska A, Romanowski M, Walecka-Kapica E, Kaczka A, Chojnacki C, Padysz M, Siedlecka M, Bierla JB, Steinert RE, Cukrowska B. Effects of Microencapsulated Sodium Butyrate, Probiotics and Short Chain Fructooligosaccharides in Patients with Irritable Bowel Syndrome: A Study Protocol of a Randomized Double-Blind Placebo-Controlled Trial. J Clin Med. 2022 Nov 7;11(21):6587. doi: 10.3390/jcm11216587.
PubMed 36362815
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Efficacy of Microencapsulated Sodium Butyrate and a Probiotic Mixture in Patients With Irritable Bowel Syndrome - a Randomized Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05013060
- Acronym / sponsor ID
- IBS-Plus / CT/NB/110/2019/PR-MS-PS
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Probiotics, Butyric acid, Microencapsulated sodium butyrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nordic Biotic Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Lodz
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Aug 2021 (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.
According to current IBS management guidelines, probiotic administration reduces IBS-associated symptoms and improves the quality of life. The purpose of this study is to assess the effects of the combined formulation comprising microencapsulated sodium butyrate and a probiotic mixture of two Lactobacillus strains (L. rhamnosus and L. acidophilus) and three Bifidobacterium strains (B. longum, B. bifidum, and B. lactis) on the incidence and severity of clinical symptoms in patients diagnosed with irritable bowel syndrome (IBS) based on the Rome IV criteria.
Microencapsulated sodium butyrate is a short-chain fatty acid (SCFA) with biological effects on the gastrointestinal mucosa; it constitutes a key source of energy for enterocytes. Butyrate was shown to have a trophic effect on the colon epithelium and to help restore the disrupted structural and functional integrity of the gastrointestinal tract. These unique properties of sodium butyrate result in its beneficial effects on the abdominal symptoms (such as diarrhea, constipation, abdominal pain) in patients with IBS. This study will assess the effects of the mixture of sodium butyrate and multi-strain probiotic on the rate and severity of clinical symptoms in IBS patients, by taking into account their nutritional status and body composition.
Detailed description
The study schedule includes five visits:the screening/baseline visit, whose purpose is to qualify patients to be included in the study, the randomization visit (visit 0), at which patients will be given a probiotic/butyric acid or placebo, and three follow-up visits (at weeks 4, 8, and 12 after randomization).
All patients will undergo:
- A physical examination - at each visit;
- Nutritional status assessment - at visit 0 and at weeks 4 and 12 of treatment;
- Anthropometric measurements - at visit 0 and at weeks 4 and 12 of treatment;
- Body composition analysis via bioelectrical impedance analysis (BIA) with the use of a Bodystat machine - at visit 0 and at 4 and 12 weeks of treatment;
- Laboratory tests (including complete blood count; liver function tests; bilirubin, amylase, creatinine, CRP, and glucose levels; electrolytes; and an SARS-CoV2 antigen cassette test conducted by a doctor) at the screening visit; and cytokines (IL-6 and macrophage inflammatory protein 1β (MIP-1ß)) at visit 0 and at weeks 4 and 12 of treatment;
- Disease severity will be rated with the IBS symptom severity score (IBS-SSS) developed by Francis, Morris, and Whorwell, with mild, moderate, and severe cases indicated by scores of <175, 175-300, and >300, respectively. In addition, the following scales will be used to assess IBS treatment efficacy: IBS-Quality of Life (IBS-QOL), IBS-Global Improvement Scale (IBS-GIS), and IBS - Adequate Relief (IBS-AR).
- The number and type of bowel movements will be assessed with the Bristol Stool Formation scale.
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 |
|---|---|---|
| The mixture of probiotics and microcapsulated sodium butyrate | Active comparator | Dietary Supplement: Probiotics and microcapsulated sodium butyrateOne billion of the following strains: Bifidobacterium lactis FloraActive 32269, Bifidobacterium longum FloraActive 32946, Bifidobacterium bifidum FloraActive 32043, Lactobacillus rhamnosus FloraActive 19070-2, Lactobacillus acidophilus FloraActive 32418 and 150 mg microcapsulated sodium butyrate, and 64 mg fructooligosaccharides |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Males and females aged from 18 to 70 years, inclusive;
- Good physical and mental condition assessed based on the patient's history and physical examination;
- Laboratory test results (complete blood count, blood chemistry panel) within normal limits or considered not to be clinically significant by the Investigator; negative SARS-CoV-2 antibody test;
- A voluntarily provided written informed consent;
- Diagnosis of IBS based on the Rome IV criteria, e.g. recurrent abdominal pain at least one day a week for the last three months, associated with two or more of the following symptoms (these should be present for the last three months, with the onset of symptoms six months before diagnosis):
Key exclusion criteria (20 listed)
- Unclassified IBS;
- Cardiovascular disorders: uncontrolled hypertension (blood pressure >170/100 mmHg), cerebrovascular disease;
- Respiratory disorders (asthma, chronic obstructive pulmonary disease [COPD]).
- Hepatic impairment (including status post cholecystectomy), renal impairment, and unexplained blood biochemistry abnormalities: serum creatinine levels over twice the upper limit of normal, AST or ALT levels over twice the upper limit of normal.
- Gastrointestinal conditions other than IBS, including clinical or endoscopic diagnosis of gastroenteritis.
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 |
|---|---|---|
| Probiotics and microcapsulated sodium butyrateThe patients who give their consent to take part in this study, will receive an oral microencapsulated sodium butyrate and a mixture of probiotics formulation 2 times a day for a period of 12 weeks. | Dietary supplement | The mixture of probiotics and microcapsulated sodium butyrate |
| MaltodextrinThe patients who give their consent to take part in this study will receive an oral maltodextrin as placebo 2 times a day for a period of 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)
Time frame: Severity of symptoms from baseline at 4, 8 and 12 weeks of intervention
IBS-SSS 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.
Improvement or worsening of IBS global symptoms using Global Improvement Scale (IBS-GIS)
Time frame: Improvement/worsening assessed after 4, 8 and 12 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 an adequate relief
Time frame: Adequate Relief after 4, 8 and 12 weeks of interventions
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.
Changes in Quality of Life
Time frame: Quality of Life from baseline at 4, 8 and 12 weeks of intervention
The IBS-Quality of Life (IBS-QOL) is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale, thus yielding a total score that has a theoretical range of 34 to 170, with higher scores indicating worse QOL.
5 secondary outcomes
Changes in number and type of stools
Time frame: From baseline for 12 weeks of intervention in 1 week intervals
Changes in severity of pain
Time frame: From baseline for 12 weeks of intervention in 1 week intervals
Changes in flatulence/abdominal distension
Time frame: From baseline for 12 weeks of intervention in 1 week intervals
Changes in Body Mass Index (BMI)
Time frame: From baseline at 4 and 12 weeks of intervention
Body composition analysis
Time frame: From baseline at 4 and 12 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 28 Feb 2024.
- Derived from this study: PubMed 39120544Lee CC, Kono T, Syed F, Weaver SA, Sohn P, Wu W, Chang G, Liu J, Slak Rupnik M, Evans-Molina C. Sodium butyrate prevents cytokine-induced beta-cell dysfunction through restoration of stromal interaction molecule 1 expression and activation of store-operated calcium entry. FASEB J. 2024 Aug 15;38(15):e23853. doi: 10.1096/fj.202302501RR.
- Derived from this study: PubMed 36362815Gasiorowska A, Romanowski M, Walecka-Kapica E, Kaczka A, Chojnacki C, Padysz M, Siedlecka M, Bierla JB, Steinert RE, Cukrowska B. Effects of Microencapsulated Sodium Butyrate, Probiotics and Short Chain Fructooligosaccharides in Patients with Irritable Bowel Syndrome: A Study Protocol of a Randomized Double-Blind Placebo-Controlled Trial. J Clin Med. 2022 Nov 7;11(21):6587. doi: 10.3390/jcm11216587.
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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.
Anita Gąsiorowska, MD, PhD principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics and microcapsulated sodium butyrate and Maltodextrin in people with Irritable Bowel Syndrome, run by Nordic Biotic Sp. z o.o. 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 19 inclusion and 20 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 28 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 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: Severity of symptoms from baseline at 4, 8 and 12 weeks of intervention). The study lists 4 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 NCT05013060, which also lists 2 linked publications.
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 28 Feb 2024.