Clinical trial NCT05731232: Effects of Vivatlac Synbiotikum in Patients With Irritable Bowel Syndrome
Official title: Effects of Vivatlac Synbiotic in Patients With Irritable Bowel Syndrome - A Randomized, Double-Blind, Placebo-Controlled Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized allocation to verum or placebo group of similar size
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Severity of IBS using Severity of Symptoms Scale (IBS-SSS)
timeFrame: Change from baseline after 4, 8 and 12 weeks of treatment
measure: Changes of IBS severity using the IBS Global Improvement Scale (IBS-GIS)
timeFrame: Change from baseline after 4, 8 and 12 weeks of treatment
measure: Changes in adequate relief of IBS symptoms (IBS-AR)
timeFrame: Change from baseline after 4, 8 and 12 weeks of treatment
Secondary outcomes:
measure: Changes in type of stools
timeFrame: Change from baseline weekly for 12 weeks of intervention
measure: Average number of daily bowel movements during the last week
timeFrame: Change from baseline weekly for 12 weeks of intervention
measure: Severity of pain using a five point scale of predefined severity levels
timeFrame: Change from baseline weekly for 12 weeks of intervention
measure: Severity of bloating using a five point scale of predefined severity levels
timeFrame: Change from baseline weekly for 12 weeks of intervention
measure: Stool pressure using a five point scale of predefined severity levels
timeFrame: Change from baseline weekly for 12 weeks of intervention
measure: Feeling of incomplete evacuation of stool
timeFrame: Change from baseline weekly for 12 weeks of intervention
Other outcomes:
Locations:
city: Krynki
country: Poland
facility: Family doctor's outpatient clinic "Panacea"
city: Stawiszyn
country: Poland
facility: Family doctor's clinic
Study officials:
affiliation: Calisia University, Kalisz, Poland
name: Jacek Piatek, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piatek J, Sommermeyer H, Bernatek M, Ciechelska-Rybarczyk A, Oleskow B, Mikkelsen LS, Barken KB. Persistent infection by Salmonella enterica servovar Typhimurium: are synbiotics a therapeutic option? - a case report. Benef Microbes. 2019 Mar 13;10(2):211-217. doi: 10.3920/BM2018.0080. Epub 2018 Dec 21.
citation: Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332.
citation: Sommermeyer H, Pituch HM, Wultanska D, Wojtyla-Buciora P, Piatek J, Bernatek M. Inhibition of Quinolone- and Multi-Drug-Resistant Clostridioides Difficile Strains by Multi Strain Synbiotics-An Option for Diarrhea Management in Nursing Facilities. Int J Environ Res Public Health. 2021 May 30;18(11):5871. doi: 10.3390/ijerph18115871.