Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients

Официальное название

Effects of Vivatlac Synbiotic on the Gut Microbiota of Patients With Irritable Bowel Syndrome - A Randomized, Double-blind, Placebo-Controlled, 12 Weeks Clinical Trial

Обзор

Multi-center, randomized, double-blind, placebo-controlled, 12 weeks trial investigating the effects of a nine-strain synbiotic (Vivatlac Synbiotikum) on the gut microbiota of IBS patients

Подробное описание

The study design is a multi-centre, randomized, double-blind, placebo-controlled clinical trial in patients diagnosed with Irritable Bowel Syndrome (IBS). Diagnosis of IBS is performed with the World Gastroenterology Organisation's IBS questionnaire for health care providers. Assessment of the severity of IBS is done by using the IBS Severity Scoring System (IBS-SSS). IBS patients with moderate to severe IBS will be included in the study (IBS-SSS ≥ 175). A four-week treatment-free screening phase is used to evaluate the patients' IBS symptoms and stool characteristics using a patient diary.

The screening phase is followed by treatment with one capsule per day of a nine-strain synbiotic (Vivatlac® Synbiotikum) or with an identical-looking 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 longum ES-1, 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. In addition, each capsule contains 68 mg of fructooligosaccharides (FOS).

Treatment effects on severity of IBS symptoms is assessed by using the IBS-Severity Scoring System (IBS-SSS), before the start of treatment and after 4, 8, and 12 weeks of treatment. Changes of IBS severity is assessed by using the IBS-Global Improvement Scale (IBS-GIS), before the start of treatment and after 4, 8, and 12 weeks of treatment. Patients are assessed for IBS adequate relief by using the IBS-Adequate Relief scale (IBS-AR), after 4, 8, and 12 weeks of treatment. Stool form characteristics is assessed with the Bristol Stool Form Scale (BSFS), at the start of the screening phase, at the start of treatment, and after 4, 8, and 12 weeks of treatment.

Stool samples are taken from all patients before the start of treatment and after 12 weeks of treatment. Fecal samples will be analyzed for gut microbiota profiles using 16S rRNA sequencing (taxonomic identification of bacterial genera) and/or nanopore shotgun sequencing (species-level identification). The presence of gut inflammation will be assessed by measuring fecal calprotectin as a biomarker for gut inflammation.

Вмешательства

• Пищевая добавка Vivatlac Synbiotic
  Vivatlac Synbiotic containing 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 longum ES1, 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 case
• Пищевая добавка Placebo
  Capsule containing maize starch with identical appearance as verum.

Первичные конечные точки

• Changes of gut-microbiota composition using 16S rRNA sequencing (taxonomic identification of bacterial genera) [Срок оценки: Measured before the start of treatment and at the end of the 12-week treatment.]
• Changes of gut-microbiota composition using nanopore shotgun sequencing (species-level identification) [Срок оценки: Measured before the start of treatment and at the end of the 12-week treatment]

Вторичные конечные точки (5)

• Measurement of calprotectin levels in fecal samples [Срок оценки: Measured before the start of treatment and at the end of the 12-week treatment.]
• Severity of IBS using the IBS-Severity Scoring System (IBS-SSS) [Срок оценки: Measured at enrollment, start of the treatment phase, and after 4, 8, and 12 weeks of treatment.]
• Changes of IBS severity using the IBS Global Improvement Scale (IBS-GIS) [Срок оценки: Measured at the start of the treatment phase, and after 4, 8, and 12 weeks of treatment.]
• Changes in adequate relief of IBS-symptoms (IBS-AR) [Срок оценки: Measured at the start of the treatment phase, and after 4, 8, and 12 weeks of treatment.]
• Changes of stool form characteristics with the Bristol Stool Form Scale (BSFS) [Срок оценки: Measured at the start of the treatment phase, and after 4, 8, and 12 weeks of treatment.]

Критерии участия

Критерии включения

• diagnosed for Irritable Bowel Syndrome using the IBS questionnaire for Health Care Providers of the World Global Gastroenterology Organization
• IBS severity assessed with the IBS-Severity Scoring System (IBS-SSS) being ≥ 175 points (indicating medium or severe IBS).

Критерии исключения

• 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 tested positive for presence of Clostridioides difficile
• patient being pregnant, lactating, or planning to become pregnant during the next 3 months
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Польша · 2 центра

• State Hospital Jarocin — Jarocin
• State Hospital Jarocin — Jarocin

Публикации

• 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
• 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
• 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
• Sommermeyer H, Piatek J. Synbiotics as Treatment for Irritable Bowel Syndrome: A Review. Microorganisms. 2024 Jul 21;12(7):1493. doi: 10.3390/microorganisms12071493. PMID 39065261
• Sommermeyer H, Chmielowiec K, Bernatek M, Olszewski P, Kopczynski J, Piatek J. Results from a Cross-Sectional Observational Study Examining Irritable Bowel Syndrome Patients Six Months After Finishing Their Participation in the ViIBS Trial. Nutrients. 2024 Nov 15;16(22):3911. doi: 10.3390/nu16223911. PMID 39599697
• 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

Идентификаторы

NCT: NCT07235228 · Kalisz 2025-02 ViIBS Trial III

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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