Home Ingredients Lactobacillus paracasei IJH-SONE68 (Heat-Killed)
Respiratory Health

Lactobacillus paracasei IJH-SONE68 (Heat-Killed)

Lacticaseibacillus paracasei IJH-SONE68 (formerly Lactobacillus paracasei)
Evidence Level
Limited
2 Clinical Trials
6 Documented Benefits
2/5 Evidence Score

Lacticaseibacillus paracasei IJH-SONE68 is a lactic acid bacterium that Hiroshima University researchers isolated from a fig leaf and deposited in Japan's NITE patent depositary as NITE P-02242. The tested ingredient is pineapple juice fermented with the strain, heat-treated and spray-dried, so the cells are not alive; the strain makes exopolysaccharides that its developers propose as the active part. Two 12-week placebo-controlled trials used four capsules a day. In 60 adults with year-round allergy symptoms, a self-rated nose, eye and head symptom score improved more than on placebo, while a rating of difficulty in daily life and total IgE did not differ. In 80 adults with overweight, visceral fat, the main outcome, did not differ from placebo. Both trials were run by the developers and funded by Sone Farm Co., Ltd. according to the papers (the trial registries name Asahi Kohsan Co., Ltd.), and no retail product name was found.

Studied Dose Four capsules a day for 12 weeks in both published trials: 1,040 mg of heat-killed IJH-SONE68 powder with about 5x10^5 cells in total (about 1.3x10^5 cells per 260 mg capsule). The trial registry records list 1,000 mg a day.
Active Compound Heat-killed Lacticaseibacillus paracasei IJH-SONE68 (NITE P-02242) with its culture broth: the strain is grown in pineapple juice, and the broth is heat-treated, spray-dried and combined with dextrin in capsules. The strain makes an acidic exopolysaccharide made mainly of mannose and a neutral one built from α-1,6-linked N-acetylglucosamine chains.

Benefits

Self-rated nasal, eye and head comfort

In a small trial of 60 adults with year-round allergy symptoms, a self-rated score of nose, eye and head symptoms, one of two main outcomes, improved more than on placebo over 12 weeks (p = 0.008), mainly sneezing, nose-blowing, watery eyes and head dullness. The other main outcome, a rating of difficulty in daily life, did not differ (p = 0.380). The trial stopped at 60 of 100 planned participants.

Supported by Trial 1

IgE antibody levels

In the same 60-person trial, total serum IgE, a secondary outcome, did not change differently from placebo (p = 0.361). Allergen-specific IgE was also planned as an outcome, but too few participants tested positive for any single allergen for the authors to analyze it.

Supported by Trial 1

Liver enzyme blood markers

In 80 adults with overweight, changes in the liver enzymes AST and ALT, secondary outcomes, did not differ significantly from placebo (p = 0.054). In the allergy trial, AST, ALT, ALP and cholinesterase fell more than on placebo, but these were safety checks rather than planned outcomes, and participants had not been selected for raised levels.

Supported by Trial 2, Trial 1

Visceral fat and body weight measures

In 80 adults with a BMI of 25 to 29.99, visceral fat area, the main outcome, fell similarly on the capsules and on placebo over 12 weeks (p = 0.830). BMI, body fat percentage, waist size, blood glucose and blood lipids also did not differ. The authors noted the human dose was far below the amount that reduced fat gain in mice.

Supported by Trial 2

Gut bacteria composition

In the overweight trial, the share of the butyrate-producing genus Anaerostipes in stool rose more than on placebo (p < 0.05), a secondary measure; no other genus discussed by the authors differed significantly. Whether this shift affects health was not tested.

Supported by Trial 2

Inflammation responses in mouse studies (lab and animal work)

In mice, the strain's exopolysaccharide given by mouth reduced ear swelling, IL-4 activity and IgE in a skin contact allergy model, and eased stool and colon changes in a chemically induced colon inflammation model. These are animal results from the developers' laboratory and have not been tested as outcomes in people.

Supported by Trial 2, Trial 1

Mechanism of action

1

Exopolysaccharides

IJH-SONE68 secretes an acidic exopolysaccharide made mainly of mannose and a neutral one made of α-1,6-linked N-acetylglucosamine chains, a structure its discoverers reported as new in bacteria. The developers report that these polysaccharides inhibit the enzyme hyaluronidase in laboratory tests and propose them as the active part of the heat-killed powder.

2

Th2 immune signaling in animal models

In mice, the exopolysaccharide lowered IL-4 activity and serum IgE in a contact allergy model, and in a colon inflammation model it lowered the inflammatory signal MIP-2 and raised IL-10. In the contact allergy model, heat-killed cells reduced swelling under conditions where living cells did not. Cytokines were not measured in the human trials.

3

Gut microbiota shift (proposed)

The developers propose that a rise in Anaerostipes, seen in the overweight trial, could explain the lower AST and ALT readings, which did not differ significantly from placebo (p = 0.054). This is a hypothesis from one trial's secondary data and has not been tested directly.

Clinical trials

1
Heat-killed IJH-SONE68 in adults with year-round nasal and eye allergy symptoms: 12-week RCT
PubMed

Double-blind, randomized, placebo-controlled parallel trial at Hiroshima University (May 2019 to July 2021) of four capsules a day of heat-killed IJH-SONE68 grown in pineapple juice (1,040 mg of powder with about 5x10^5 cells) or dextrin placebo for 12 weeks; people with pineapple hypersensitivity or on regular medication were excluded; registered UMIN000036317 (Noda et al. 2021, Nutrients).

60 adults aged 21 to 70 with year-round allergy symptoms who met symptom-score and daily-life rating thresholds; 29 took IJH-SONE68 and 31 placebo, and 57 completed.

Self-assessed symptom scores, one of two primary outcomes, improved more than with placebo (p = 0.008; change of -3.6 versus -1.9 points), driven by head dullness, watery eyes and nose-blowing and sneezing. The visual analogue scale for difficulty in daily life, the other primary outcome, did not differ (p = 0.380), and total IgE did not change (p = 0.361). Adverse events did not differ between groups. The trial ended at 60 of the 100 participants planned, which the authors attributed to time, funding and COVID-19 limits. Funded by Sone Farm according to the paper, while the trial registry names Asahi Kohsan Co., Ltd. as the funding source; no author listed a Sone Farm affiliation.

2
Heat-killed IJH-SONE68 in adults with overweight: 12-week RCT
PubMed

Double-blind, randomized, placebo-controlled parallel trial at Hiroshima University (May 2019 to July 2021) of four capsules a day of heat-killed IJH-SONE68 with its pineapple-juice culture broth (about 1.3x10^5 cells per 260 mg capsule) or dextrin placebo for 12 weeks; registered UMIN000036318 (Danshiitsoodol et al. 2022, Nutrients).

80 adults aged 23 to 70 with a BMI of 25 to 29.99 (39 on the test capsules, 41 on placebo); 77 completed.

Visceral fat area, the primary outcome, fell similarly in both groups (p = 0.830), and BMI, body fat, waist size, blood glucose and blood lipids did not differ. Changes in AST and ALT, secondary outcomes, did not differ significantly (p = 0.054). The stool share of the genus Anaerostipes rose more than on placebo (p < 0.05). Adverse events did not differ. Enrollment stopped at 80 of the 100 planned. Funded by Sone Farm according to the paper, while the trial registry names Asahi Kohsan Co., Ltd.; co-author Tomoyuki Uchida, credited in the paper with funding acquisition and listed with a Sone Farm affiliation in the group's 2021 mouse study, is listed here with a Hiroshima University affiliation only.

Side effects and drug interactions

Common Potential side effects

In two 12-week trials (60 and 80 adults), adverse events graded with standard criteria did not differ between the heat-killed IJH-SONE68 capsules and placebo.
The powder is made from fermented pineapple juice, and both trials excluded people with pineapple hypersensitivity.
Both trials excluded pregnant or breastfeeding women and people taking regular medication, so safety in these groups has not been studied.
Both trials were run by the strain's developers and funded by Sone Farm Co., Ltd. according to the papers (the registry records name Asahi Kohsan Co., Ltd. as the funding source); no independent trial has been published.

Important Drug interactions

No interaction studies have been published.
Allergy medicines: the allergy trial excluded people taking medicines, supplements or functional foods that may affect allergy symptoms, so use alongside them has not been studied.
Both trials excluded people on regular medication; discuss use with your clinician if you take prescription medicines.

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Frequently asked questions about Lactobacillus paracasei IJH-SONE68 (Heat-Killed)

Is IJH-SONE68 a live probiotic?

No. In the published trials the strain was grown in pineapple juice and the broth was heat-treated and spray-dried, so the capsules contained killed cells and their exopolysaccharides. Preparations of inactivated microbes like this fall under what an international expert panel calls postbiotics.

How much was used in the studies?

Both trials used four capsules a day for 12 weeks, together 1,040 mg of powder with about 5x10^5 heat-killed cells. No retail product name or label dose was found, so check that any product names the strain IJH-SONE68.

What did the trial in people with year-round nose and eye symptoms find?

In 60 adults, a self-rated symptom score improved more than on placebo over 12 weeks, mainly sneezing, nose-blowing, watery eyes and head dullness. A second main outcome, difficulty in daily life, and total IgE did not differ. The trial ended early at 60 of 100 planned participants and was funded by Sone Farm. Discuss ongoing symptoms with your clinician.

Does it change body fat or liver markers?

In 80 adults with overweight, visceral fat and other body measures did not differ from placebo. Liver enzymes AST and ALT did not differ significantly in that trial, and a drop in the allergy trial came from safety checks rather than a planned outcome, so these markers remain untested as a main result.

Do results for other L. paracasei strains apply to IJH-SONE68?

No. Each strain is tested separately with its own form and dose. Other heat-killed L. paracasei strains, such as KW3110, have their own studies, and the species page summarizes several strains side by side.

What is Lactobacillus paracasei IJH-SONE68?

Lacticaseibacillus paracasei IJH-SONE68 is a lactic acid bacterium that Hiroshima University researchers isolated from a fig leaf and deposited in Japan's NITE patent depositary as NITE P-02242.

What is Lactobacillus paracasei IJH-SONE68 used for?

Lactobacillus paracasei IJH-SONE68 is researched primarily for Respiratory Health. In a small trial of 60 adults with year-round allergy symptoms, a self-rated score of nose, eye and head symptoms, one of two main outcomes, improved more than on placebo over 12 weeks (p = 0.

Is Lactobacillus paracasei IJH-SONE68 safe, and does it have side effects?

Side effects and cautions reported for Lactobacillus paracasei IJH-SONE68 include: In two 12-week trials (60 and 80 adults), adverse events graded with standard criteria did not differ between the heat-killed IJH-SONE68 capsules and placebo. The powder is made from fermented pineapple juice, and both trials excluded people with pineapple hypersensitivity. It may also interact with some medications. Lactobacillus paracasei IJH-SONE68 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 paracasei IJH-SONE68 interact with any medications?

Possible interactions include: No interaction studies have been published. Allergy medicines: the allergy trial excluded people taking medicines, supplements or functional foods that may affect allergy symptoms, so use alongside them has not been studied. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Lactobacillus paracasei IJH-SONE68?

NutraSmarts rates the evidence for Lactobacillus paracasei IJH-SONE68 as Limited (2 out of 5). It is backed by 2 study summaries and 11 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(11 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. Noda M, Kanno K, Danshiitsoodol N, Higashikawa F, Sugiyama M. Plant-Derived Lactobacillus paracasei IJH-SONE68 Improves Chronic Allergy Status: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2021;13(11):4022. doi: 10.3390/nu13114022.PubMedUsed to support: 60 adults aged 21 to 70 with year-round allergy symptoms took four capsules a day of heat-killed IJH-SONE68 powder (1,040 mg with about 5x10^5 cells, grown in pineapple juice) or dextrin placebo for 12 weeks. The self-assessed symptom score, a co-primary outcome, improved more than on placebo (p = 0.008); the daily-life VAS, the other co-primary, did not differ (p = 0.380), and total IgE did not change. AST, ALT, ALP and cholinesterase fell in safety monitoring. Registered UMIN000036317; stopped at 60 of 100 planned. Funded by Sone Farm.
  2. Danshiitsoodol N, Noda M, Kanno K, Uchida T, Sugiyama M. Plant-Derived Lactobacillus paracasei IJH-SONE68 Improves the Gut Microbiota Associated with Hepatic Disorders: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial. Nutrients. 2022;14(21):4492. doi: 10.3390/nu14214492.PubMedUsed to support: 80 adults with a BMI of 25 to 29.99 took four capsules a day of heat-killed IJH-SONE68 with its pineapple-juice culture broth or dextrin placebo for 12 weeks. Visceral fat area, the primary outcome, did not differ (p = 0.830), nor did other body measures, glucose or lipids; AST and ALT changes did not reach significance (p = 0.054), and stool Anaerostipes rose more than on placebo. Registered UMIN000036318; funded by Sone Farm.
  3. Noda M, Sultana N, Hayashi I, Fukamachi M, Sugiyama M. Exopolysaccharide Produced by Lactobacillus paracasei IJH-SONE68 Prevents and Improves the Picryl Chloride-Induced Contact Dermatitis. Molecules. 2019;24(16):2970. doi: 10.3390/molecules24162970.PubMedUsed to support: Mouse study: the exopolysaccharide made by IJH-SONE68, given by mouth, reduced ear swelling, ear IL-4 expression and the rise in serum IgE in a chemically induced contact allergy model, and heat-killed cells reduced swelling where living cells did not. The paper describes the strain as fig-leaf derived and reports that its exopolysaccharide inhibits hyaluronidase. One author was from Asahi Kohsan Co., Ltd. No human data.
  4. Noda M, Danshiitsoodol N, Kanno K, Uchida T, Sugiyama M. The Exopolysaccharide Produced by Lactobacillus paracasei IJH-SONE68 Prevents and Ameliorates Inflammatory Responses in DSS-Induced Ulcerative Colitis. Microorganisms. 2021;9(11):2243. doi: 10.3390/microorganisms9112243.PubMedUsed to support: Mouse study: the IJH-SONE68 exopolysaccharide given by mouth improved stool consistency, bleeding and colon shortening in a chemically induced colon inflammation model, lowered MIP-2 expression and raised IL-10. The methods state the strain is deposited as NITE P-02242, and co-author Uchida T is listed with a Sone Farm Co., Ltd. affiliation. No human data.
  5. Noda M, Sugimoto S, Hayashi I, Danshiitsoodol N, Fukamachi M, Sugiyama M. A novel structure of exopolysaccharide produced by a plant-derived lactic acid bacterium Lactobacillus paracasei IJH-SONE68. J Biochem. 2018;164(2):87-92. doi: 10.1093/jb/mvy048.PubMedUsed to support: Laboratory study: IJH-SONE68, isolated from a fig leaf, makes an acidic exopolysaccharide composed mainly of mannose and a neutral one of α-1,6-linked N-acetylglucosamine chains, reported as new in bacteria; the strain's genome was sequenced. No health outcomes.
  6. Ma Q, Noda M, Danshiitsoodol N, Sugiyama M. Atractylodes Japonica Rhizome Extract Fermented with a Plant-Derived Lacticaseibacillus paracasei (Lactobacillus paracasei) IJH-SONE68 Improves the Wheat Gliadin-Induced Food Allergic Reaction in Mice. Nutrients. 2025;17(7):1151. doi: 10.3390/nu17071151.PubMedUsed to support: Mouse study of a different product: an Atractylodes japonica rhizome extract fermented with IJH-SONE68 lowered anaphylaxis scores, total IgE and IL-4 and raised IFN-gamma in gliadin-sensitized mice. It shows the strain is also used to ferment herbal extracts; it says nothing about the heat-killed capsule powder in people.
  7. Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021;18(9):649-667. doi: 10.1038/s41575-021-00440-6.PubMedUsed to support: Expert consensus defining a postbiotic as a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host, which is the category heat-killed bacterial preparations such as IJH-SONE68 powder fall under; it does not evaluate this strain.
  8. Hiroshima University (sponsor); WHO International Clinical Trials Registry Platform (accessed 2026). Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status (UMIN000036317) UMIN Clinical Trials Registry, via WHO ICTRP. 2019;Trial ID JPRN-UMIN000036317; first enrollment 7 May 2019; accessed 2026..SourceUsed to support: Registry record, not PubMed-indexed. Lists two primary outcomes (change in the self-evaluated allergy score and in the daily-life difficulty VAS), total and specific IgE as secondary outcomes, a target of 100 participants, 4 capsules (1,000 mg) a day of sterilized IJH-SONE68-fermented pineapple juice powder for 12 weeks, and Asahi Kohsan Co., Ltd. as funding source.
  9. Hiroshima University (sponsor); WHO International Clinical Trials Registry Platform (accessed 2026). Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on overweight (UMIN000036318) UMIN Clinical Trials Registry, via WHO ICTRP. 2019;Trial ID JPRN-UMIN000036318; registered 28 March 2019; accessed 2026..SourceUsed to support: Registry record, not PubMed-indexed. Lists visceral fat area as the primary outcome and gut flora, body measures, glucose, lipids, AST, ALT and gamma-GTP as secondary outcomes, a target of 100 participants, 4 capsules (1,000 mg) a day for 12 weeks, and Asahi Kohsan Co., Ltd. as funding source.
  10. Hiroshima University. News release on the IJH-SONE68 overweight trial (in Japanese), 2 November 2022 Hiroshima University news release. 2022;Hiroshima University public relations office, 2 November 2022; accessed 2026..SourceUsed to support: University news release, not PubMed-indexed. States that the fig-leaf strain grows well in pineapple juice, that the powdered fermented juice was put into capsules for the trial, and that a supplement product is being developed; it names no product or brand.
  11. Hiroshima University. News release on the IJH-SONE68 exopolysaccharide mouse study (in Japanese), 19 November 2021 Hiroshima University news release. 2021;Hiroshima University public relations group, 19 November 2021; accessed 2026..SourceUsed to support: University news release, not PubMed-indexed. Lists co-author Tomoyuki Uchida with a Sone Farm Co., Ltd. affiliation, states that the research group's plant-derived library holds more than 1,000 strains, and describes plans to develop supplement and drug products from the strain's exopolysaccharide; it names no product.