Effects of Vivatlac Synbiotikum in Patients With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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Multi-centre, randomized, double-blind, placebo-controlled trial investigating the effects of a nine-strain synbiotic (Vivatlac Synbiotikum) in IBS patients.

Detailed Description
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The study design is a multi-centre, randomized, double-blind, placebo controlled clinical trial in patients diagnosed with IBS. Diagnosis of IBS with the World Gastroenterology Organisation's IBS questionnaire for health care providers. Assessment of severity of IBS by using the IBS Severity of Symptoms Scale (IBS-SSS). IBS patients with moderate to severe IBS will be included into the study (IBS-SSS ≥ 175). A four weeks screening phase is used to evaluate patients' IBS and their capability to report IBS symptoms using a patient diary. The screening phase is followed by treatment with one capsule per day of a nine-strain synbiotic (Vivatlac® Synbiotikum) or placebo for twelve weeks. Each capsule of Vivatlac® Synbiotikum contains a total of 4.5 x 10˄9 colony forming units (CFU) of nine different probiotic bacteria. Probiotic bacteria strains and their CFU amount per capsule are: Lactococcus lactis Ll-23, 9.00 x 10˄8 CFU; Lactobacillus helveticus SP 27, 9.00 x 10˄8 CFU; Bifidobacterium longum Bl-05, 6.75 x 10˄8 CFU; Bifidobacterium breve Bb-03, 4.50 x 10˄8 CFU; Lacticaseibacillus rhamnosus Lr-32, 4.50 x 10˄8 CFU; Streptococcus thermophiles St-21, 4.50 x 10˄8 CFU; Lacticaseibacillus casei Lc-11, 2.25 x 10˄8 CFU; Lactiplantibacillus plantarum Lp-115, 2.25 x 10˄8 CFU; Bifidobacterium bifidum Bb-02, 2.25 x 10˄8 CFU. Effects will be assessed by using the IBS Severity of Symptoms Scale (IBS-SSS), assessment of changes of IBS severity by using the IBS Global Improvement Scale (IBS-GIS) and assessment of IBS relief by using the IBS Adequate Relief scale (IBS-AR) every four weeks. Additional measures will be stool consistency using the Bristol Stool Scale, number of bowel movements, severity of pain, severity of bloating, stool pressure, feeling of incomplete evacuation of stool and adverse events using a patient diary.

Official Title
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Effects of Vivatlac Synbiotic in Patients With Irritable Bowel Syndrome - A Randomized, Double-Blind, Placebo-Controlled Clinical Trail

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Vivatlac Synbiotikum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed for Irritable Bowel Syndrome using the IBS questionnaire for health care providers of the World Global Gastroenterology Organization IBS-SSS ≥ 175 points Exclusion Criteria: patients currently taking products containing probiotics or have taken this kind of products during the last 3 months patients currently taking antibiotics or have taken antibiotics during the last 3 months patients having a concurrent severe illness (malignancies, uncontrolled hypertension or diabetes, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma or COPD, hyper- or hypothyroidism patients having chronic bowel disorders other than IBS, including inflammatory bowel disease, gastroenteritis, stomach and duodenal cancer, celiac disease patient being pregnant or are lactating patient being diagnosed to have a lactose intolerance patients using motility drugs or dietary fiber supplements withing 2 weeks before study start patient taking anti-coagulant medication patients have participated in another clinical trial within the last three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized allocation to verum or placebo group of similar size
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Pacebo<br>Capsules containing maize starch with identical appearance as verum. One capsule taken per day before bedtime. Treatment duration 12 weeks. | Dietary Supplement: Vivatlac Synbiotikum<br>* Each capsule of Vivatlac® Synbiotikum contains a total of 4.5 x 10˄9 colony forming units (CFU) of nine different probiotic bacteria. Probiotic bacteria strains and their CFU amount per capsule are: Lactococcus lactis Ll-23, 9.00 x 10˄8 CFU; Lactobacillus helveticus SP 27, 9.00 x 10˄8 CFU; Bifidobacterium longum Bl-05, 6.75 x 10˄8 CFU; Bifidobacterium breve Bb-03, 4.50 x 10˄8 CFU; Lacticaseibacillus rhamnosus Lr-32, 4.50 x 10˄8 CFU; Streptococcus thermophiles St-21, 4.50 x 10˄8 CFU; Lacticaseibacillus casei Lc-11, 2.25 x 10˄8 CFU; Lactiplantibacillus plantarum Lp-115, 2.25 x 10˄8 CFU; Bifidobacterium bifidum Bb-02, 2.25 x 10˄8 CFU. As a prebiotic component each capsule contains 63 mg of fructooligosaccharides.<br>|
| Experimental: Vivatlac Synbiotikum<br>Vivatlac Synbiotikum for twelve weeks. One capsule containing a mixture of nine different probiotic bacteria with a total amount of 4.5 x 10˄9 colony forming units taken per day before bedtime. Treatment duration 12 weeks. | Dietary Supplement: Vivatlac Synbiotikum<br>* Each capsule of Vivatlac® Synbiotikum contains a total of 4.5 x 10˄9 colony forming units (CFU) of nine different probiotic bacteria. Probiotic bacteria strains and their CFU amount per capsule are: Lactococcus lactis Ll-23, 9.00 x 10˄8 CFU; Lactobacillus helveticus SP 27, 9.00 x 10˄8 CFU; Bifidobacterium longum Bl-05, 6.75 x 10˄8 CFU; Bifidobacterium breve Bb-03, 4.50 x 10˄8 CFU; Lacticaseibacillus rhamnosus Lr-32, 4.50 x 10˄8 CFU; Streptococcus thermophiles St-21, 4.50 x 10˄8 CFU; Lacticaseibacillus casei Lc-11, 2.25 x 10˄8 CFU; Lactiplantibacillus plantarum Lp-115, 2.25 x 10˄8 CFU; Bifidobacterium bifidum Bb-02, 2.25 x 10˄8 CFU. As a prebiotic component each capsule contains 63 mg of fructooligosaccharides.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of IBS using Severity of Symptoms Scale (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 50 points is associated with a clinically meaningful improvement. | Change from baseline after 4, 8 and 12 weeks of treatment | 
| Changes of IBS severity using the IBS Global Improvement Scale (IBS-GIS) | IBS-Global Improvement Scale asseses changes of 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 | Change from baseline after 4, 8 and 12 weeks of treatment | 
| 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. | Change from baseline after 4, 8 and 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in type of stools | Average consistency of last week's stool assessed weekly before intervention and then weekly duing the treatment period. 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. | Change from baseline weekly for 12 weeks of intervention | 
| Average number of daily bowel movements during the last week | Average number of bowel movements per day assessed before intervention and then weekly during the treatment period. | Change from baseline weekly for 12 weeks of intervention | 
| Severity of pain using a five point scale of predefined severity levels | The severity of pain assessed before intervention and then weekly during the treatment period 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. | Change from baseline weekly for 12 weeks of intervention | 
| Severity of bloating using a five point scale of predefined severity levels | The severity of bloating assessed before intervention and then weekly during the treatment period using a patient-defined 5 point Linkert scale: point 0 - no bloating, and points1-4 with higher scores indicating worse bloating. | Change from baseline weekly for 12 weeks of intervention | 
| Stool pressure using a five point scale of predefined severity levels | The severity of stool pressure assessed before intervention and then weekly during the treatment period using a patient-defined 5 point Linkert scale: point 0 - no stool pressure, and points1-4 with higher scores indicating worse stool pressure. | Change from baseline weekly for 12 weeks of intervention | 
| Feeling of incomplete evacuation of stool | The feeling of incomplete evacuation of stool assessed before intervention and then weekly during the treatment period using a dichotomous single item that asks participants Please rate the feeling of incomplete evacuation of stool you have experienced during this week by selecting one of the two answers. Answer are NO SUCH FEELING or THERE IS AN INCOMPLETE BOWEL MOVEMENT. | Change from baseline weekly for 12 weeks of intervention |