NCT04206410

Effectiveness of Probiotics Stabilized With Cryoprotection Technology in Patients With Irritable Bowel Syndrome

Completed NA Last updated 3 February 2021

What this trial tests

NA trial testing Probiotic in Irritable Bowel Syndrome in 80 participants. Completed in 10 December 2019.

Timeline

1 September 2018

Primary endpoint
10 September 2019

10 December 2019

Quick facts

Lead sponsor	Children's Memorial Health Institute, Poland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	1 September 2018
Primary completion	10 September 2019
Estimated completion	10 December 2019
Sites	1 location across Poland

Drugs / interventions tested

• Probiotic
• Maltodextrin (MALTODEXTRIN) — full drug profile →

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Children's Memorial Health Institute, Poland

Who can join

Adults 16 to 60, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Irritable bowel syndrome (IBS) is one of the most common diseases of the digestive tract in adults, which pathogenesis is not fully understood. It is assumed that intestinal dysbiosis affecting the functioning of the gut-brain axis may be important. Probiotics are live microorganisms that, when administered at the right dose, have a positive effect on human health. Probiotic mechanism of action is related to the modulation of intestinal microbiota. Clinical studies confirm that probiotics administered to patients with IBS have positive health effects. Clinical effects depend primarily on the selection of probiotic strains, but no less important is their viability and stability in the preparation administered to patients. Unfortunately, obtaining stability (a strictly defined number of live probiotic strains in the preparation throughout the shelf life of the preparation) is very technologically difficult. As shown by the audit of the Polish Supreme Audit Office (NIK), almost 90% of probiotics sold on the Polish market do not meet these criteria. There were probiotic preparations that by the end of their expiration date had less than 100 live bacterial cells from the declared number of about one billion. The only preparations that successfully passed NIK inspections turned out to be preparations in which the technology of double microcapsulation of bacteria was used. New technologies are constantly being sought that increase both the survival of bacterial strains in the preparation and the resistance of the strains to hydrochloric acid and bile, which in turn contributes to delivering the right dose of probiotics to the target site of activity, i.e. the small and large intestine. Recent developed an innovative technology called bacterial cryoprotection, which, compared to traditional lyophilization, leads to an increase in the stability of the bacterial cell wall membranes and protects them against negative factors both external (high temperature, humidity etc.) and internal (gastric acid, bile). Therefore, the purpose of the clinical trial is to assess the effectiveness of cryoprotected probiotics in patients with IBS.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Probiotics, prebiotics, and postbiotics in health and disease.
   Ji J, Jin W, Liu SJ, Jiao Z, et al · · 2023 · cited 198× · PMID 37929014 · DOI 10.1002/mco2.420
2. Efficacy of <i>Bifidobacterium longum</i> alone or in multi-strain probiotic formulations during early life and beyond.
   Mills S, Yang B, Smith GJ, Stanton C, et al · · 2023 · cited 70× · PMID 36896934 · DOI 10.1080/19490976.2023.2186098
3. Gut Microbiota Dysbiosis: Pathogenesis, Diseases, Prevention, and Therapy.
   Shen Y, Fan N, Ma SX, Cheng X, et al · · 2025 · cited 69× · PMID 40255918 · DOI 10.1002/mco2.70168
4. The Effectiveness of Synbiotic Preparation Containing <i>Lactobacillus</i> and <i>Bifidobacterium</i> Probiotic Strains and Short Chain Fructooligosaccharides in Patients with Diarrhea Predominant Irritable Bowel Syndrome-A Randomized Double-Blind, Placebo-Controlled Study.
   Skrzydło-Radomańska B, Prozorow-Król B, Cichoż-Lach H, Majsiak E, et al · · 2020 · cited 68× · PMID 32635661 · DOI 10.3390/nu12071999
5. Synbiotics as Treatment for Irritable Bowel Syndrome: A Review.
   Sommermeyer H, Piątek J. · · 2024 · cited 4× · PMID 39065261 · DOI 10.3390/microorganisms12071493
6. The Occurrence of Gluten-Related Antibodies, Sensitization to Selected Food Allergens, and Antibodies against Intrinsic Factor in Adult Patients with Diarrhea-Predominant Irritable Bowel Syndrome.
   Bierła JB, Cukrowska B, Skrzydło-Radomańska B, Prozorow-Król B, et al · · 2023 · cited 2× · PMID 37511778 · DOI 10.3390/jpm13071165