An interventional study of Vivatlac Synbiotikum in Irritable Bowel Syndrome, sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz. Completed at 2 sites in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz · Not applicable, Interventional, and Treatment
Multi-centre, randomized, double-blind, placebo-controlled trial investigating the effects of a nine-strain synbiotic (Vivatlac Synbiotikum) in IBS patients.
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's enrollment of 201 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Capsules containing maize starch with identical appearance as verum. One capsule taken per day before bedtime. Treatment duration 12 weeks.
Dietary Supplement: Vivatlac Synbiotikum
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
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.
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.
Time frame: 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
Time frame: 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.
Time frame: Change from baseline after 4, 8 and 12 weeks of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline weekly for 12 weeks of intervention
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz