Effects of Vivatlac Synbiotikum in Patients With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— ViIBS  

Official title:

Effects of Vivatlac Synbiotic in Patients With Irritable Bowel Syndrome - A Randomized, Double-Blind, Placebo-Controlled Clinical Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05731232
• Other study ID #: Kalisz 2023-02
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: The President Stanislaw Wojciechowski State University of Applied Sciences in Kalisz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Poland	Family doctor's outpatient clinic "Panacea"	Krynki
Poland	Family doctor's clinic	Stawiszyn

Sponsors (1)

Lead Sponsor	Collaborator
The President Stanislaw Wojciechowski State University of Applied Sciences in Kalisz

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Change from baseline weekly for 12 weeks of intervention
Secondary	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.	Change from baseline weekly for 12 weeks of intervention
Secondary	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.	Change from baseline weekly for 12 weeks of intervention
Secondary	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.	Change from baseline weekly for 12 weeks of intervention
Secondary	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.	Change from baseline weekly for 12 weeks of intervention
Secondary	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.	Change from baseline weekly for 12 weeks of intervention