Benefits
Breath test readings in adults carrying a stomach bacterium
In two small single-blind studies in adults with H. pylori but no symptoms, 20 billion non-living cells a day for 14 days lowered urea breath test values. Against placebo the difference was significant in one study (p = 0.026) and only a trend in the other (p = 0.084). Breath test values are lab markers of infection, and this is not a treatment for H. pylori infection and does not replace prescribed therapy.
Breath test and symptom scores over 28 days in adults with mild indigestion
In 24 adults with H. pylori and mild indigestion, 28 days of placebo followed by 28 days of Pylopass (200 mg a day) gave no significant drop in breath test values during the Pylopass phase (p = 0.130) and no significant symptom difference between the phases (p = 0.200). The study was funded by the supplier at the time. It is not a treatment for H. pylori infection.
Clearance rates when added to prescribed antibiotics
In three placebo-controlled trials in adults with H. pylori taking prescribed antibiotics, adding DSM 17648 raised clearance in two (96.7% vs 86.0% per protocol; 91.1% vs 68.9%) and not in the largest (81.8% vs 83.7%). This is drug co-treatment of an infection, not a supplement benefit, and it does not replace prescribed therapy.
Digestive side effects during prescribed antibiotic courses
During antibiotic therapy for H. pylori, digestive side effects were fewer with DSM 17648 than placebo in two trials: less abdominal distention (5.1% vs 16.3%) and diarrhea (11.1% vs 23.5%) in one, and fewer digestive side effect cases (25 vs 34) in another, where the share with any side effect did not differ. A third saw less headache and abdominal pain. It does not replace prescribed therapy.
Digestive symptom scores alongside prescribed therapy
In two placebo-controlled trials in adults on antibiotic therapy for H. pylori, symptom questionnaire scores fell more with DSM 17648. In a third, restricted to people with functional dyspepsia, symptoms and quality of life improved in both groups with no difference between them. These are infected patients on drugs, so the results do not show a general digestive benefit, and it does not replace prescribed therapy.
With an acid reducer in place of antibiotics: one small trial without placebo
In 46 adults with functional dyspepsia and H. pylori, Pylopass twice daily with the acid reducer pantoprazole for 8 weeks cleared the infection in 65% versus 74% on pantoprazole plus two antibiotics (p = 0.75). With no placebo, no reported blinding and 23 people per group, the trial cannot show the two are equal. It does not replace prescribed therapy.
Occasional upper digestive discomfort in healthy adults: trial unpublished
The only trial in generally healthy adults, sponsored by Novozymes, gave one capsule a day or placebo for 8 weeks to 324 people with occasional heartburn or upper abdominal discomfort, scored with a reflux and indigestion questionnaire. It was completed in May 2026, but no results had been posted or published when this record was written.
Mechanism of action
Clumping with stomach bacteria in lab tests
Among 700 Lactobacillus strains screened by the developer, DSM 17648 was one of eight that clumped (co-aggregated) with spiral H. pylori cells, within seconds, in artificial gastric juice across pH 2 to 8. It did not clump with Campylobacter jejuni or tested gut commensals. The developers propose that clumped bacteria lose their grip on the stomach lining and are flushed out; this was not shown in people.
Activity of non-living cells
The binding activity survived freeze-drying and spray-drying (spray-dried cells gave no viable counts in lab tests), so the developers attribute it to surface structures of the strain rather than to live probiotic growth. Because the product is non-living, findings for live L. reuteri strains such as DSM 17938 do not apply to it, and vice versa.
Gut bacteria shifts during antibiotic therapy
In one trial during triple antibiotic therapy, stool samples at week 2 showed about 4.0-fold more Proteobacteria and 8.1-fold more Escherichia-Shigella in the placebo group than with DSM 17648, and Faecalibacterium and some other genera rose with DSM 17648. These are stool microbiome markers in infected patients on drugs.
Clinical trials
Single-blind placebo-controlled pilot; within 6 concordant twin pairs treatment was randomized, while 4 discordant twin pairs and 4 singletons took placebo for 14 days, then active tablets for 14 days, in a fixed order; four 250 mg tablets a day giving 20 billion freeze-dried non-living cells; not registered; five of seven authors from Organobalance, one holding its stock (Holz et al. 2015, Probiotics Antimicrob Proteins)
20 adults positive for H. pylori by breath test, without symptoms (both twins of 6 twin pairs, the infected twin of 4 discordant pairs, and 4 singletons), analyzed as 14 treatment units; recruited from a German twin and general population screen of 128 people.
Breath test values fell more after active tablets than after placebo (change -4.9 vs -0.6, p = 0.026); absolute values were 14.1 at baseline, 12.7 after placebo and 11.9 after active treatment. Values 4 to 6 weeks later did not differ from the end of treatment. No side effects were reported. Breath test values are lab markers of infection.
Single-blind study with a fixed order: 14 days of placebo tablets, then 14 days of spray-dried non-living DSM 17648 (four 250 mg tablets, 20 billion cells a day), with breath tests up to 24 weeks after; registered ISRCTN70607306; the authors thank Organobalance for support and declare no conflict (Mehling and Busjahn 2013, Nutrients)
22 adults (5 men, 17 women, mean age 47) with H. pylori and breath test values above 12, without symptoms, from a screen of 364 people in Berlin.
Median breath test values were 20 at baseline, 18 after placebo and 16 after Pylopass. Pylopass versus baseline was significant (p = 0.011), but Pylopass versus placebo was not (p = 0.084, a trend). The authors report the lowering was still detectable 24 weeks later. No side effects and no changes in blood safety markers.
Single-blind study with a fixed order: 28 days of placebo, then 28 days of Pylopass tablets (100 mg Pylopass, about 10 billion spray-dried cells, per tablet; two a day); registered NCT02051348; funded by Lonza, then the supplier (Buckley et al. 2018, BMC Nutr)
24 adults (13 women, 11 men, median age 43.5) with H. pylori and mild dyspepsia in Cork, Ireland.
The main outcome did not reach significance: breath test values fell 3.14 during the Pylopass phase (p = 0.130) after rising 3.79 during placebo. Overall GSRS symptom scores did not differ between phases (p = 0.200); the fall from day 1 to day 56, spanning both phases, was significant (p = 0.005). No side effects were reported.
Randomized double-blind placebo-controlled trial; non-living DSM 17648 or placebo for 4 weeks, the last 2 together with 14-day standard triple therapy; dose not given in the abstract; Europe PMC lists a grant from Vita Medical Science and Technology Co., Ltd. (Yang et al. 2021, Helicobacter)
200 treatment-naive adults with H. pylori in Guangzhou, China (100 per group).
The primary outcome was null: eradication was 81.8% with DSM 17648 and 83.7% with placebo (intention to treat, p = 0.730). As secondary results, mean GSRS after treatment was lower (1.9 vs 2.7, p = 0.030), with less abdominal distention (5.1% vs 16.3%) and diarrhea (11.1% vs 23.5%). Drug co-treatment of an infection.
Randomized double-blind placebo-controlled trial; 2 weeks of standard triple therapy, then one 200 mg DSM 17648 capsule or a corn starch placebo a day for 4 weeks (dose from the registry, NCT05399862, posted after completion); viability of the cells not stated in the abstract; collaborator and one author from Y.S.P. Industries (M) Sdn. Bhd. (Ismail et al. 2023, Helicobacter)
90 treatment-naive adults with H. pylori in Kuala Lumpur (45 per group).
Eradication at week 8 was 91.1% vs 68.9% (intention to treat, p = 0.007). GSRS total scores fell more with DSM 17648 (12.41 vs 4.24 points, p = 0.004), and fewer reported headache (0% vs 15.6%) and abdominal pain (0% vs 13.3%). The placebo group's clearance after triple therapy was low. Drug co-treatment of an infection.
Randomized double-blind placebo-controlled multicenter trial; Helinorm capsules with 200 mg Pylopass (20 billion inactivated cells) or dextrin placebo twice daily for 28 days, the first 14 with esomeprazole, amoxicillin and clarithromycin; registered ISRCTN20716052; sponsored by Novozymes A/S and Parusin GmbH, which employed one author (Ivashkin et al. 2024, Clin Transl Gastroenterol)
129 adults aged 18 to 65 in Russia with functional dyspepsia and H. pylori; 117 analyzed per protocol (60 Pylopass, 57 placebo).
Per-protocol eradication was 96.7% vs 86.0% (p = 0.039). Symptoms and quality of life improved in both groups with no difference between them. Any adverse effect: 30.3% vs 38.0% (p = 0.228); total digestive adverse effect cases were fewer (25 vs 34, p = 0.049). No serious adverse effects. Drug co-treatment of an infection.
Randomized trial without placebo, blinding not reported; Pylopass (Remedia Laboratories) twice daily plus pantoprazole 40 mg a day for 8 weeks, versus pantoprazole with amoxicillin and clarithromycin; dose in mg and funding not stated (Muresan et al. 2019, Med Pharm Rep)
46 adults (13 men, 33 women, mean age 48.8) in Cluj-Napoca, Romania, with functional dyspepsia and H. pylori found on biopsy; 23 per group.
Eradication by stool antigen 30 days after therapy was 65.22% with Pylopass plus pantoprazole and 73.91% with triple therapy (p = 0.75). The authors call the efficacy similar, but the trial was small, reported no blinding and had no placebo, so it cannot show the regimens are equal.