Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05731232
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2023-01-31
Brief Title:
Effects of Vivatlac Synbiotikum in Patients With Irritable Bowel Syndrome
Sponsor:
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Organization:
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Study Overview
Official Title:
Effects of Vivatlac Synbiotic in Patients With Irritable Bowel Syndrome - A Randomized Double-Blind Placebo-Controlled Clinical Trail
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ViIBS
Brief Summary:
Multi-centre randomized double-blind placebo-controlled trial investigating the effects of a nine-strain synbiotic Vivatlac Synbiotikum in IBS patients
Detailed Description:
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 Organisations 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 45 x 109 colony forming units CFU of nine different probiotic bacteria Probiotic bacteria strains and their CFU amount per capsule are Lactococcus lactis Ll-23 900 x 108 CFU Lactobacillus helveticus SP 27 900 x 108 CFU Bifidobacterium longum Bl-05 675 x 108 CFU Bifidobacterium breve Bb-03 450 x 108 CFU Lacticaseibacillus rhamnosus Lr-32 450 x 108 CFU Streptococcus thermophiles St-21 450 x 108 CFU Lacticaseibacillus casei Lc-11 225 x 108 CFU Lactiplantibacillus plantarum Lp-115 225 x 108 CFU Bifidobacterium bifidum Bb-02 225 x 108 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None