Effects of Vivatlac Synbiotikum in Patients With Irritable Bowel Syndrome

NCT05731232 | Completed

• 1 other identifier: Kalisz 2023-02
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Changes in type of stools

  Change from baseline weekly for 12 weeks of intervention

• Average number of daily bowel movements during the last week

  Change from baseline weekly for 12 weeks of intervention

• Severity of pain using a five point scale of predefined severity levels

  Change from baseline weekly for 12 weeks of intervention

• Severity of bloating using a five point scale of predefined severity levels

  Change from baseline weekly for 12 weeks of intervention

• Stool pressure using a five point scale of predefined severity levels

  Change from baseline weekly for 12 weeks of intervention

Study Arms (2)

Pacebo

PLACEBO COMPARATOR

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

EXPERIMENTAL

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

Interventions

Vivatlac Synbiotikum DIETARY_SUPPLEMENT

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.

Pacebo; Vivatlac Synbiotikum

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed for Irritable Bowel Syndrome using the IBS questionnaire for health care providers of the World Global Gastroenterology Organization
• IBS-SSS ≥ 175 points

You may not qualify if:

• 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

Sponsors & Collaborators

• The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz: lead

Study Sites (2)

Family doctor's outpatient clinic "Panacea"

Krynki, 27-230, Poland

Location

Family doctor's clinic

Stawiszyn, 62-820, Poland

Location

Related Publications (4)

• 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.

  PMID: 30574800 BACKGROUND

• 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.

  PMID: 32403297 BACKGROUND

• 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.

  PMID: 34070727 BACKGROUND

• Sommermeyer H, Chmielowiec K, Bernatek M, Olszewski P, Kopczynski J, Piatek J. Effectiveness of a Balanced Nine-Strain Synbiotic in Primary-Care Irritable Bowel Syndrome Patients-A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024 May 16;16(10):1503. doi: 10.3390/nu16101503.

  PMID: 38794741 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jacek Piatek, Prof. Dr.

  Calisia University, Kalisz, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized allocation to verum or placebo group of similar size

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 16, 2023
• Study Start: February 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)