Lactobacillus rhamnosus Rosell-11 (R0011)

Lacticaseibacillus rhamnosus R0011 (CNCM I-1720)
Evidence Level
Preliminary
1 Clinical Trial
6 Documented Benefits
1/5 Evidence Score

Lactobacillus rhamnosus Rosell-11 (R0011), now classified as Lacticaseibacillus rhamnosus, is a probiotic strain from Lallemand Health Solutions (formerly Institut Rosell), isolated from a dairy starter culture and deposited as CNCM I-1720. Most human research gives it in blends: as about 95% of Lacidofil® with Lactobacillus helveticus R0052, with Bifidobacterium bifidum HA-132 in Prenatis™, and with L. paracasei R0215; those results belong to the blends and are not credited to R0011 here. Tested alone in one placebo-controlled trial, 1 billion live cells a day for 4 weeks did not improve sinus and nasal quality-of-life scores in 77 people with long-standing sinus inflammation. Small tracking studies found it passes through the gut alive, and its other findings come from cell studies.

Studied Dose Alone: 500 million live cells in a chewable tablet twice daily (1 billion a day) for 4 weeks in the one placebo-controlled trial. In blends it is dosed with partner strains, for example as about 95% of 2 to 8 billion CFU a day in Lacidofil®; see that page.
Active Compound Live Lacticaseibacillus rhamnosus R0011 (Rosell-11, CNCM I-1720), formerly named Lactobacillus rhamnosus, counted in live cells or colony-forming units (CFU).

Benefits

Sinus and nasal quality-of-life scores

In a placebo-controlled trial in 77 patients aged 15 to 70 with chronic rhinosinusitis, chewable tablets of 500 million R0011 cells twice daily for 4 weeks did not improve sinonasal quality-of-life scores compared with placebo at 4 or 8 weeks, and symptom frequency and medication use did not differ. It is the only published placebo-controlled trial of R0011 alone.

Survival through the digestive tract

In an open study in 14 healthy volunteers taking capsules of an R11 rhamnosus strain with a little of an R52 strain for 12 days, the rhamnosus strain was found in every stool sample at the end, and the main gut bacterial groups did not shift. In a 17-person crossover study, an R0052 plus R0011 capsule raised stool detection of both strains.

Role inside the Lacidofil® blend

Most human trials that include R0011 test Lacidofil® (Lactobacillus rhamnosus R0011 and Lactobacillus helveticus R0052), in which R0011 is about 95% of each dose. In its largest trial, 886 young children with stomach illness did no better than on placebo. Those results belong to the blend, are covered on its own page and cannot be credited to R0011 alone.

Mother and infant health with a two-strain pregnancy blend

In 180 healthy pregnant women, one capsule a day of 5 billion CFU of R0011 with Bifidobacterium bifidum HA-132 (Prenatis™) from late pregnancy to 4 to 6 weeks after birth did not significantly lower diagnosed infections in the mothers, the main outcome. Fewer women had any infection (8 vs 18) and infants had fewer infection days. The maker funded it.

Vaccine antibody response in older adults with a two-strain blend

In 592 adults aged 65 to 89, one capsule a day of R0011 with L. paracasei R0215 (6 billion CFU in all) for 30 days around a COVID-19 mRNA booster did not change the share without detectable spike antibodies at 6 months, the main outcome, and self-reported infections did not differ significantly. Lallemand supplied the capsules.

Gut cell binding and pathogen contact (lab work)

In human intestinal cell cultures, R0011 bound to the cells and, in a model with a mucus layer, settled in the mucus and reduced Campylobacter jejuni attachment and invasion. In another cell line it did not reduce Campylobacter invasion, while R0052 did. These are laboratory findings and do not show protection in people.

Mechanism of action

1

Calming inflammatory signals in gut cells (lab work)

In HT-29 intestinal cells, R0011 changed cytokine output more broadly than other lactic acid bacteria tested, and substances it secretes lowered the activity of genes in the NF-κB and MAPK pathways and inflammatory signals after TNF-α or Salmonella secretions, while raising the immune brakes DUSP1, ATF3 and TRIB3. No human outcome has been tied to this.

2

A sequenced, dairy-derived strain

R0011 was isolated from a dairy starter culture in 1976, deposited at the Institut Pasteur collection as CNCM I-1720 and kept its strain code when the species moved from Lactobacillus to Lacticaseibacillus in 2020. Its draft genome has about 2.9 million bases. The strain code, not the species name, identifies this material.

3

Strain-specific results

Probiotic effects differ between strains: in the same cell test, R0052 limited Campylobacter invasion and R0011 did not. Results for other L. rhamnosus strains, such as GG, HN001 or HA-114, should not be assumed for R0011, and blend results should not be assumed for R0011 on its own.

Clinical trials

1
R0011 Alone in Chronic Rhinosinusitis, 4 Weeks
PubMed

Randomized, double-blind, placebo-controlled parallel trial (NCT00396162); chewable tablet of 500 million live R0011 cells or matched placebo twice daily for 4 weeks, with follow-up to 8 weeks; primary outcome change in SNOT-20 sinonasal quality-of-life score; University of Michigan sponsor with Institut Rosell as registered collaborator (Mukerji et al. 2009, Otolaryngol Head Neck Surg)

77 patients with chronic inflammatory rhinosinusitis without bacterial sinus infection (39 probiotic, 38 placebo); registry eligibility ages 15 to 70; 37 and 35 analyzed at 8 weeks

SNOT-20 change from baseline did not differ between groups at 4 weeks (P = 0.79) or 8 weeks (P = 0.23); the registry gives mean reductions of 1.8 on R0011 and 5.5 on placebo at 8 weeks. Scores improved within the R0011 group at 4 weeks (P = 0.002) but not at 8. Symptom frequency, medication use and side effects did not differ. The abstract does not state the funder; Institut Rosell, now part of Lallemand, is a registered collaborator.

Side effects and drug interactions

Common Potential side effects

In the 4-week trial of R0011 alone, no serious adverse events occurred, and bloating, diarrhea, loose stools or abdominal pain were reported by 14 of 39 people on R0011 and 17 of 38 on placebo.
In 180 pregnant women taking R0011 with B. bifidum HA-132, adverse events were similar to placebo, and the 8 serious events (2 on the probiotic, 6 on placebo) were judged unrelated to it.
Serious adverse events from probiotics have been reported in severely ill or immunocompromised children, including those with central venous catheters; avoid live probiotics in these settings unless the medical team advises them.
Pregnancy and breastfeeding: R0011 was studied in pregnancy only inside one maker-funded two-strain blend trial; ask your doctor first.
Long-term safety: the only trial of R0011 alone lasted 4 weeks, so there is little information on longer use of the strain by itself.

Important Drug interactions

Antibiotics: no trial of R0011 alone tested timing with antibiotics; ask your pharmacist how to space a live probiotic around antibiotic doses.
Immunosuppressants and chemotherapy: the R0011 trial excluded people with weakened immune systems, including those on oral steroids; people taking these medicines should use live probiotics only with medical advice.
Nasal steroid sprays and antibiotics for sinus symptoms: in the R0011 trial, medication use did not differ from placebo; it was tested alongside usual care and does not replace it.
No other drug interactions have been studied for R0011 alone.

Frequently asked questions about Lactobacillus rhamnosus Rosell-11 (R0011)

What is Lactobacillus rhamnosus R0011?

R0011, also called Rosell-11, is a probiotic strain of Lacticaseibacillus rhamnosus (formerly Lactobacillus rhamnosus) from Lallemand Health Solutions, formerly Institut Rosell. It was isolated from a dairy starter culture in 1976 and deposited as CNCM I-1720. Results for other L. rhamnosus strains, such as GG or HA-114, do not carry over to it.

Has R0011 been studied on its own?

Rarely. In the one placebo-controlled trial of R0011 alone, 77 people with long-standing sinus inflammation took 1 billion live cells a day for 4 weeks, and their sinus and nasal quality-of-life scores did not improve more than on placebo. Most other human studies give it in blends with other strains.

How does R0011 relate to Lacidofil?

Lacidofil® blends R0011 with Lactobacillus helveticus R0052 at about 95 to 5, so most of each dose is R0011. The blend has its own page, because its trial results, including several that found no benefit, cannot be credited to either strain alone. R0011 also appears with other partner strains in Prenatis™ and other Lallemand blends.

How much R0011 was used in studies?

The trial of R0011 alone used one chewable tablet of 500 million live cells twice daily, or 1 billion a day, for 4 weeks. Blends dose it with partner strains, for example as about 95% of 2 to 8 billion CFU a day in Lacidofil®. Follow the product label.

What is Lactobacillus rhamnosus Rosell-11?

Lactobacillus rhamnosus Rosell-11 (R0011), now classified as Lacticaseibacillus rhamnosus, is a probiotic strain from Lallemand Health Solutions (formerly Institut Rosell), isolated from a dairy starter culture and deposited as CNCM I-1720.

What is Lactobacillus rhamnosus Rosell-11 used for?

NutraSmarts does not list Lactobacillus rhamnosus Rosell-11 under a health category. What the research covers: In a placebo-controlled trial in 77 patients aged 15 to 70 with chronic rhinosinusitis, chewable tablets of 500 million R0011 cells twice daily for 4 weeks did not improve sinonasal quality-of-life scores compared with placebo at 4 or 8 wee…

Is Lactobacillus rhamnosus Rosell-11 safe, and does it have side effects?

Side effects and cautions reported for Lactobacillus rhamnosus Rosell-11 include: In the 4-week trial of R0011 alone, no serious adverse events occurred, and bloating, diarrhea, loose stools or abdominal pain were reported by 14 of 39 people on R0011 and 17 of 38 on placebo. In 180 pregnant women taking R0011 with B. It may also interact with some medications. Lactobacillus rhamnosus Rosell-11 is not right for everyone, so check with a healthcare provider first if you are pregnant or breastfeeding, have a medical condition, or take prescription medication.

Does Lactobacillus rhamnosus Rosell-11 interact with any medications?

Possible interactions include: Antibiotics: no trial of R0011 alone tested timing with antibiotics; ask your pharmacist how to space a live probiotic around antibiotic doses. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Lactobacillus rhamnosus Rosell-11?

NutraSmarts rates the evidence for Lactobacillus rhamnosus Rosell-11 as Preliminary (1 out of 5). It is backed by 1 study summary and 15 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(15 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Mukerji SS, Pynnonen MA, Kim HM, Singer A, Tabor M, Terrell JE. Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial. Otolaryngol Head Neck Surg. 2009;140(2):202-8. doi: 10.1016/j.otohns.2008.11.020.PubMedUsed to support: Randomized, double-blind, placebo-controlled trial in 77 patients with chronic inflammatory rhinosinusitis: L. rhamnosus R0011 (500 million active cells per tablet twice daily, n = 39) or placebo (n = 38) for 4 weeks. Within the probiotic group, SNOT-20 scores improved from baseline at 4 weeks (P = 0.002) but not at 8 weeks (P = 0.37), and the rhinological domain improved 9.3% at 4 weeks before returning to baseline. Changes did not differ between probiotic and placebo from baseline to 4 weeks (P = 0.79) or 8 weeks (P = 0.23). Symptom frequency, medication use and side effects did not differ. The authors concluded that R0011 did not improve sinonasal quality of life compared with placebo. The abstract lists the first author at Baylor College of Medicine and does not state the funder; PubMed lists the publication type Research Support, Non-U.S. Gov't.
  2. U.S. National Library of Medicine, ClinicalTrials.gov. Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis (NCT00396162), study record. ClinicalTrials.gov. 2026;Registry record NCT00396162, accessed 2026..SourceUsed to support: Trial registry record, not PubMed-indexed, read in 2026. Lists the University of Michigan as lead sponsor and Institut Rosell as collaborator, 77 enrolled, triple masking, and a chewable tablet of 500 million active R0011 cells twice daily for 4 weeks against matched placebo tablets. The primary outcome was the mean reduction in SNOT-20 score from baseline to 8 weeks: 1.8 (SD 12) on the probiotic (n = 37) and 5.5 (SD 14) on placebo (n = 35), P = 0.23. No serious adverse events occurred; 14 of 39 on the probiotic and 17 of 38 on placebo reported bloating, diarrhea, loose stools or abdominal pain. The registry states the principal investigator is not a sponsor employee.
  3. Auclair-Ouellet N, Tremblay A, Kassem O, Caballero-Calero SE, Bronner S, Binda S. Probiotics as Adjuvants to Standard Helicobacter pylori Treatment: Evidence for the Use of Lacidofil(®), an Established Blend of Thoroughly Characterized Strains. Microorganisms. 2025;13(10):2223. doi: 10.3390/microorganisms13102223.PubMedUsed to support: Review written by Lallemand Health Solutions employees. States that L. rhamnosus Rosell-11 was isolated from a dairy starter culture in 1976 and deposited as I-1720 at the Institut Pasteur CNCM (Paris), that it was identified as Lactobacillus rhamnosus before the 2020 reclassification of the Lactobacillus genus, and that Lacidofil, available since 1995, blends L. rhamnosus Rosell-11 and L. helveticus Rosell-52 at a 95:5 ratio.
  4. Tompkins TA, Barreau G, de Carvalho VG. Draft genome sequence of probiotic strain Lactobacillus rhamnosus R0011. J Bacteriol. 2012;194(4):902. doi: 10.1128/JB.06584-11.PubMedUsed to support: Genome announcement by Institut Rosell-Lallemand scientists: R0011 is described as a commercially available probiotic widely used in dietary supplements and pharmaceutical products; its draft genome has 10 contigs totaling 2,900,620 bases with a G+C content of 46.7%. Laboratory data only.
  5. Firmesse O, Mogenet A, Bresson JL, Corthier G, Furet JP. Lactobacillus rhamnosus R11 consumed in a food supplement survived human digestive transit without modifying microbiota equilibrium as assessed by real-time polymerase chain reaction. J Mol Microbiol Biotechnol. 2008;14(1-3):90-9. doi: 10.1159/000106087.PubMedUsed to support: Open (uncontrolled) study in 14 healthy volunteers: after 3 weeks without fermented products, they took 4 capsules a day, which the abstract states contained 2 x 10^9 L. rhamnosus R11 and 1 x 10^8 L. acidophilus R52, for 12 days, then a 12-day washout. At the end of intake, R11 was detected in every volunteer's stool at a mean 7.1 log10 CFU equivalents per gram, while R52 was found in only 1 volunteer. The dominant fecal bacterial groups did not change. The abstract does not name the product supplier. Cited as an other-product reference: the capsule contained two strains.
  6. Dahl WJ, Ford AL, Coppola JA, Lopez D, Combs W, Rohani A, Ukhanova M, Culpepper T, Tompkins TA, Christman M, Mai V. Calcium phosphate supplementation increases faecal Lactobacillus spp. in a randomised trial of young adults. Benef Microbes. 2016;7(1):3-10. doi: 10.3920/BM2014.0168.PubMedUsed to support: Two small randomized, double-blind crossover studies in healthy young adults. In study 2 (n = 17), 2 capsules a day of L. helveticus R0052 with L. rhamnosus R0011, alone or with calcium carbonate or calcium phosphate, for 2-week periods all increased stool detection of both strains, with no difference among treatments; fecal Lactobacillus counts rose from baseline only with calcium phosphate, and stool frequency did not change. One author is from Lallemand Health Solutions. Cited as an other-product reference: it tests the two-strain capsule.
  7. Foster LM, Tompkins TA, Dahl WJ. A comprehensive post-market review of studies on a probiotic product containing Lactobacillus helveticus R0052 and Lactobacillus rhamnosus R0011. Benef Microbes. 2011;2(4):319-34. doi: 10.3920/BM2011.0032.PubMedUsed to support: Post-market review of Lacidofil, a combination of L. helveticus R0052 and L. rhamnosus R0011 sold in Europe, Asia and North America since 1995, co-written by a scientist at the maker. In cell work the strains adhered to human gut lining cells, helped maintain barrier function, blocked adhesion of several pathogens and lowered IL-1β, IL-8 and TNF-α. Its summary of clinical benefits predates the larger null trials of the blend and covers the blend, not R0011 alone.
  8. Freedman SB, Williamson-Urquhart S, Farion KJ, Gouin S, Willan AR, Poonai N, Hurley K, Sherman PM, Finkelstein Y, Lee BE, Pang XL, Chui L, Schnadower D, Xie J, Gorelick M, Schuh S, PERC PROGUT Trial Group. Multicenter Trial of a Combination Probiotic for Children with Gastroenteritis. N Engl J Med. 2018;379(21):2015-2026. doi: 10.1056/NEJMoa1802597.PubMedUsed to support: Cited as an other-product reference: the 886-child trial of L. rhamnosus R0011 with L. helveticus R0052 (registered as Lacidofil, about 95 to 5), 4 billion CFU twice daily for 5 days, which did not reduce moderate-to-severe gastroenteritis within 14 days (26.1% vs 24.7%, P=0.72); results are covered on the Lacidofil page. It does not test R0011 alone.
  9. Binda S, Chow-Shi-Yée M, El Salti S, Auclair-Ouellet N, Oula ML, Carton T, Leuillet S, Tomassi D, Hemmings R, Kadoch IJ. The Effect of Probiotics on Health in Pregnancy and Infants: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2025;17(11):1825. doi: 10.3390/nu17111825.PubMedUsed to support: Cited as an other-product reference. Randomized, double-blind, placebo-controlled trial (NCT03310853) in 180 healthy pregnant women given one capsule a day of Prenatis (5 billion CFU of L. rhamnosus Rosell-11 with Bifidobacterium bifidum HA-132; the strain proportions are not stated) or placebo from 28 weeks of pregnancy for about 18 weeks, through 4 to 6 weeks after birth. The primary outcome, the number of diagnosed infections in the women, showed only a trend (p = 0.07). Fewer women on the probiotic had one or more infections (8 vs 18, p = 0.05), and infants had fewer days with infections in the first month (4.7 vs 10.5, p = 0.03). Vaginal microbiota did not differ; adverse events were similar, and 8 serious adverse events (2 probiotic, 6 placebo) were judged unrelated. Funded by Lallemand Health Solutions, which supplied the product; four authors are Lallemand employees and three were paid Lallemand consultants.
  10. Pasquier JC, Chaillet N, Plourde M, Boivin G, Hamelin MÈ, Allard-Chamard H, Piché A, Baron G, Laforest-Lapointe I, Généreux M, Mâsse B, Robitaille J, Beaulieu JF, Fülöp T, Bilodeau S, Ramanathan S. Effect of probiotics on humoral responses to COVID-19 vaccination in older adults: a randomized, placebo-controlled trial (PIRATES-COV study). Gut Microbes. 2026;18(1):2699456. doi: 10.1080/19490976.2026.2699456.PubMedUsed to support: Cited as an other-product reference. Randomized, placebo-controlled trial (PIRATES-COV, NCT05195151) in 592 adults aged 65 to 89 in Quebec receiving an mRNA COVID-19 booster: one capsule a day of L. rhamnosus Rosell-11 with L. paracasei Rosell-215 (6 billion CFU per capsule in total) or placebo for 30 days, from 15 days before to 15 days after vaccination. The primary outcome, the share without detectable anti-S1-RBD antibodies at 6 months, did not differ (1.2% placebo vs 1.6% probiotic), and anti-S1-RBD levels were comparable. Anti-nucleocapsid seropositivity was lower on the probiotic at 6 months (OR 0.6, p = 0.02), and self-reported COVID-19 infection did not differ significantly (19.1% vs 13.9%, p = 0.134). Funded by the Canadian Institutes of Health Research; Lallemand Health Solutions provided the capsules and placebo. No author lists a Lallemand affiliation.
  11. Wallace TD, Bradley S, Buckley ND, Green-Johnson JM. Interactions of lactic acid bacteria with human intestinal epithelial cells: effects on cytokine production. J Food Prot. 2003;66(3):466-72. doi: 10.4315/0362-028x-66.3.466.PubMedUsed to support: Cell culture study comparing lactic acid bacteria strains on the human intestinal cell line HT-29: some strains suppressed the chemokine RANTES and IL-8, depending on growth medium, and L. rhamnosus R0011 generally had the broadest effects on cytokine production and bound to the cells most effectively. Laboratory work only.
  12. Jeffrey MP, MacPherson CW, Mathieu O, Tompkins TA, Green-Johnson JM. Secretome-Mediated Interactions with Intestinal Epithelial Cells: A Role for Secretome Components from Lactobacillus rhamnosus R0011 in the Attenuation of Salmonella enterica Serovar Typhimurium Secretome and TNF-α-Induced Proinflammatory Responses. J Immunol. 2020;204(9):2523-2534. doi: 10.4049/jimmunol.1901440.PubMedUsed to support: Cell culture study: substances secreted by L. rhamnosus R0011 (its secretome) dampened gene activity in the NF-κB and MAPK inflammatory pathways and lowered proinflammatory cytokines and chemokines in HT-29 intestinal cells challenged with TNF-α or with Salmonella Typhimurium secretions, and raised the negative immune regulators DUSP1, ATF3 and TRIB3. Three authors are from the Rosell Institute for Microbiome and Probiotics. Laboratory work only.
  13. Alemka A, Clyne M, Shanahan F, Tompkins T, Corcionivoschi N, Bourke B. Probiotic colonization of the adherent mucus layer of HT29MTXE12 cells attenuates Campylobacter jejuni virulence properties. Infect Immun. 2010;78(6):2812-22. doi: 10.1128/IAI.01249-09.PubMedUsed to support: Cell culture study in HT29MTXE12 cells, which carry an adherent mucus layer: L. rhamnosus R0011, L. helveticus R0052, their Lacidofil combination and other strains colonized the mucus, bound to the cells and reduced Campylobacter jejuni association, invasion and passage across the cell layer. Live bacteria and longer pre-colonization were needed. One author is from Lallemand. Laboratory work only.
  14. Wine E, Gareau MG, Johnson-Henry K, Sherman PM. Strain-specific probiotic (Lactobacillus helveticus) inhibition of Campylobacter jejuni invasion of human intestinal epithelial cells. FEMS Microbiol Lett. 2009;300(1):146-52. doi: 10.1111/j.1574-6968.2009.01781.x.PubMedUsed to support: Cell culture study: pretreatment with L. helveticus R0052 reduced Campylobacter jejuni invasion of human colon T84 cells by 35 to 41%, whereas L. rhamnosus R0011 did not reduce invasion. The authors conclude that protection depends on the pathogen strain, the probiotic strain and the cell type. Laboratory work only.
  15. Goldenberg JZ, Lytvyn L, Steurich J, Parkin P, Mahant S, Johnston BC. Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane Database Syst Rev. 2015;(12):CD004827. doi: 10.1002/14651858.CD004827.pub4.PubMedUsed to support: Safety source: the Cochrane review found no serious adverse events attributable to probiotics in the 16 pediatric trials (2,455 children) that reported adverse events, but notes serious adverse events in severely debilitated or immunocompromised children with risk factors including central venous catheters, and advises avoiding probiotics in at-risk children. R0011 was not studied.