Table 4.

Completed and ongoing clinical trials with 951 subjects in 6 countries: Germany, Ireland, Russia, Romania, China, and India on the safety and efficacy of L. reuteri DSM 17648 strain.

	Country	Study design	Result	Research institutes	Reference
1	Germany	27 subjects; strain safety and efficacy studies	Validate strain screening and testing methods and verify strain safety	HealthTwiST GmbH, Berlin, Germany; Experimental and Clinical Research Center, Berlin, Germany	Holz et al., 2015
		250mg of Pylopass daily for 2 weeks	Significant reduction in the number of H. pylori in the body
2	Germany	22 subjects; strain efficacy study	Significant reduction in the number of H. pylori in the body	HealthTwiSt GmbH, Germany	Mehling and Busjahn, 2013
		200mg of Pylopass daily for 2 weeks	Improvement was still observed 6 months after the end of the trial
3	Russia	30 subjects; strain efficacy study	Significant reduction in the number of H. pylori in the body	The Loginov Moscow Clinical Scientific Center, Moscow, Russia	Bordin, 2015
		200mg of Pylopass daily for 4 weeks	Reduced inflammatory infection in 25% of cases; improved indigestion symptoms
4	Ireland	24 subjects; strain efficacy study	Significant reduction in the number of H. pylori in the body	Atlantia Food Clinical Trials, Heron House Offices First Floor, Blackpool Retail Park, Cork T23 R50R, Ireland	Buckley et al., 2018
		200mg of Pylopass daily for 4 weeks	Significant relief of stomach discomfort
5	Romania	70 subjects; strain efficacy study	The eradication rate was 54.3% in the Pylopass group and 77.1% in the antibiotic group (p = 0.042)	Institute of Gastroenterology and Hepatology, “Grigore T. Popa” University of Medicine and Pharmacy, “Sf. Spiridon” Clinical Hospital, Iaşi, Romania	Mihai, 2019
		Combined triple therapy, 200 mg of Pylopass daily for 4 weeks	Significantly lower side effect rate in the Pylopass group (2.9% vs. 17.1%, p = 0.037)
6	Romania	46 subjects; strain efficacy study	H. pylori eradication rate: 65.22% in the probiotic group and 73.91% in the antibiotic group, with no significant difference between the two groups (p=0.75)	Department of Internal Medicine, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania	Muresan et al., 2019
		Combined triple therapy, 200 mg of Pylopass daily for 4 weeks	In both groups, eradication of H. pylori was associated with improved dyspeptic symptoms and anxiety scores in patients, with no significant differences between the two groups
7	Russia	60 subjects; strain efficacy study	Pylopass in combination with antibiotics increased eradication rate by 10%	Pavlov First Saint Petersburg State Medical University City Clinical Elizabethan Hospital, Saint Petersburg, Russia	Uspienskiy, 2016
		The antibiotic group received pantoprazole for 30 days in combination with amoxicillin and clarithromycin for 14 days; the probiotic group received pantoprazole in combination with probiotics twice daily for 8 weeks. H. pylori fecal antigen testing was performed after 30 days of treatment.	Pylopass significantly improves quality of life when used in combination with antibiotics
8	India	90 subjects; strain efficacy study	Pylopass significantly increased the eradication rate of H. pylori and reduced the intensity of gastrointestinal symptoms and treatment-related side effects; the eradication rate of Pylopass combined with triple therapy was 82.69%, significantly higher than the 68.42% in the placebo group	Department of Pharmacy, College of Pharmaceutical Sciences, Dayananda Sagar University, Bengaluru, India	Parth et al., 2021
		Combined triple therapy, 200 mg of Pylopass daily for 2 weeks	H. pylori eradication rates were lower in the 60+ age group than in the adult age group
9	China	200 subjects; strain efficacy study	The eradication rate of Pylopass combined with triple therapy was 86.2%.	Department of Gastroenterology, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China	Yang et al., 2021
		Combined triple therapy, 200 mg of Pylopass daily for 4 weeks	Significantly lower side effects in the Pylopass group, such as reduced risk of bloating and diarrhea
10	Russia	49 subjects aged 9-17 years; population-specific efficacy study	H. pylori eradication rate of 50%	National Research Tomsk Polytechnic University, Russia	Parolova et al., 2015
		200mg of Pylopass daily for 4 weeks	60% eradication rate when combined with antibiotics, and significant reduction in antibiotic side effects and discomfort
11	Russia	103 subjects aged 9-17 years; population-specific efficacy study	Pylopass in combination with antibiotics increased eradication rate by 9%	Gastroenterology Department of Saint Petersburg State Pediatric Medical University, Russia	Kornienko et al., 2020
		200 mg of Pylopass twice daily in 2 subgroups for 28 and 56 days in a controlled trial	Significant reduction in ammonia levels in the Pylopass group, demonstrating possible eradication of H. pylori
			Significantly lower side effects in the Pylopass group, such as reduced incidence of diarrhea and abdominal pain
12	Russia	200 subjects; strain efficacy study	Validation of H. pylori eradication rate	N/A	Ongoing
		Combined triple therapy, 200 mg of Pylopass daily for 4 weeks	Validation of the relief of gastrointestinal symptoms in the pre-test, placebo group and test group