NCT03100162

Effect of Oral Supplementation With Probiotics

Completed NA Last updated 6 May 2020

What this trial tests

NA trial testing Probiotic in Obesity in 81 participants. Completed in 2 February 2018.

Timeline

27 February 2016

Primary endpoint
4 January 2018

2 February 2018

Quick facts

Lead sponsor	Poznan University of Medical Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	81
Start date	27 February 2016
Primary completion	4 January 2018
Estimated completion	2 February 2018
Sites	1 location across Poland

Drugs / interventions tested

• Probiotic
• Placebo

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Poznan University of Medical Sciences

Who can join

Adults 45 to 70, female only, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Effect of oral supplementation with probiotics on cardiometabolic risk factors, microflora and intestinal epithelial permeability, mineral content and lifestyle in obese women with postmenopausal metabolic syndrome: double-blind, randomized clinical trial.

Publications & conference data

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

1. Gut microbiota in the pathogenesis and therapeutic approaches of diabetes.
   Crudele L, Gadaleta RM, Cariello M, Moschetta A. · · 2023 · cited 147× · PMID 37804567 · DOI 10.1016/j.ebiom.2023.104821
2. Dose-Dependent Effects of Multispecies Probiotic Supplementation on the Lipopolysaccharide (LPS) Level and Cardiometabolic Profile in Obese Postmenopausal Women: A 12-Week Randomized Clinical Trial.
   Szulińska M, Łoniewski I, van Hemert S, Sobieska M, et al · · 2018 · cited 117× · PMID 29914095 · DOI 10.3390/nu10060773
3. Multispecies Probiotic Supplementation Favorably Affects Vascular Function and Reduces Arterial Stiffness in Obese Postmenopausal Women-A 12-Week Placebo-Controlled and Randomized Clinical Study.
   Szulińska M, Łoniewski I, Skrypnik K, Sobieska M, et al · · 2018 · cited 71× · PMID 30400570 · DOI 10.3390/nu10111672
4. The Potential Role of Probiotics in Controlling Overweight/Obesity and Associated Metabolic Parameters in Adults: A Systematic Review and Meta-Analysis.
   Wang ZB, Xin SS, Ding LN, Ding WY, et al · · 2019 · cited 49× · PMID 31118956 · DOI 10.1155/2019/3862971
5. The effect of multistrain probiotic supplementation in two doses on iron metabolism in obese postmenopausal women: a randomized trial.
   Skrypnik K, Bogdański P, Sobieska M, Suliburska J. · · 2019 · cited 28× · PMID 31384878 · DOI 10.1039/c9fo01006h
6. Treatment With Multi-Species Probiotics Changes the Functions, Not the Composition of Gut Microbiota in Postmenopausal Women With Obesity: A Randomized, Double-Blind, Placebo-Controlled Study.
   Kaczmarczyk M, Szulińska M, Łoniewski I, Kręgielska-Narożna M, et al · · 2022 · cited 19× · PMID 35360106 · DOI 10.3389/fcimb.2022.815798
7. Human gut microbiome: Therapeutic opportunities for metabolic syndrome-Hype or hope?
   Horvath A, Zukauskaite K, Hazia O, Balazs I, et al · · 2024 · cited 15× · PMID 37771199 · DOI 10.1002/edm2.436
8. Bacterial live therapeutics for human diseases.
   Frutos-Grilo E, Ana Y, Gonzalez-de Miguel J, Cardona-I-Collado M, et al · · 2024 · cited 6× · PMID 39443745 · DOI 10.1038/s44320-024-00067-0