Effects of Vivatlac Synbiotikum in Patients With Irritable Bowel Syndrome (ViIBS)

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Vivatlac Synbiotikum

Study type: Interventional

Funder types: Other

Identifiers

NCT05731232

Kalisz 2023-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 2 patient groups, including a placebo group

Pacebo

Placebo Comparator group

Description:

Capsules containing maize starch with identical appearance as verum. One capsule taken per day before bedtime. Treatment duration 12 weeks.

Treatment:

Dietary Supplement: Vivatlac Synbiotikum

Vivatlac Synbiotikum

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vivatlac Synbiotikum