One product, one panel, one record.
BiOptimizers P3-OM (sold as Probiotic Breakthrough) — label audit
The patent number printed on the current FDA-filed label — US 5,895,858 — is an Analog Devices accelerometer test system. The strain patent is US 5,895,758, one digit away; it was filed in 1997, expired in 2017, and the live page markets a "New patented strain".
This page is an audit of a label. It records what this product’s panel discloses, what of that could be checked against a primary record, and what could not. The score below ranks this product on that disclosure and on nothing else.
The record this page rests on
- NIH label record
- Label read on
- The most recent dated artefact behind this page. Labels change; this is how old our reading of it is.
- Cohort
- D₂₇ founding teardown One of the 27 products taken apart at label level. That cohort is frozen and dated, so the audit’s published percentages cannot silently move.
- How deep this went
- Full forensic teardown Panel transcribed, every strain designator queried, every certification chased to its issuer’s own register, and the literature behind each marketing claim opened and read.
The Label Verifiability Score for this product
59.7 out of 100
Rank 72 of the 154 products in this audit the rubric can score. This rank is shared with 7 other products — 8 products sit on 59.7 and are tied. They hold the position jointly; no tiebreaker is applied, because every tiebreaker available here would be a number the rubric deliberately refused to weigh, smuggled back in to make a list look tidier.
The score measures one thing: how much of what you are buying this company tells you, and how much of that survives being checked against a source that is not the company. It does not measure whether the product works — this site holds no efficacy data of its own, and 0 of 294 organism slots in the founding cohort carry a strain with a human randomised trial for any male-specific outcome, so nobody in this category has evidence that would support a ranking by effect.
Computed over 86% of the rubric by weight — the share of the five questions below this record could answer. The remaining question is unanswered, and unanswered is not nought: it leaves the divisor rather than dragging the score down. That share travels with the number and is never dropped — this score over 86% of the weight and the same score over all of it are different claims.
| Component | Weight | What was counted, and where | Fraction | Weight × fraction |
|---|---|---|---|---|
| Strain identity printed on the panel | 0.24 | 1 of 1 organism slot carries a printed strain designator. | 1 / 1 = 1.0000 | 0.2400 |
| Per-organism amount printed | 0.20 | 1 of 1 organism slot has an amount of its own; the rest are inside a blend total. | 1 / 1 = 1.0000 | 0.2000 |
| What the CFU count is measured against | 0.22 | Potency basis "none-stated": CFU figure printed yes, single basis stated no, basis reaches expiry no — 1 of 3. | 1 / 3 = 0.3333 | 0.073333 |
| Printed designators that lead to a human trial | 0.20 | 0 of 1 checked organism slot resolves to at least one human randomised trial under the designator exactly as printed. This counts whether the identity leads to a trial, never what the trial found. | 0 / 1 = 0.0000 | 0.0000 |
| Certification confirmed at the issuer’s own register | 0.14 | Every certification on this record is brand-asserted with the register unreachable, or not yet queried. An unreachable register is a fact about the verification infrastructure, not about this brand, so it may not move its position. | Not answered | — excluded from the divisor, not counted as nought |
0.513333 — the last column added up — divided by 0.86, the weight this record could answer, is 0.5969. Multiplied by 100 and rounded to one decimal, that is the 59.7 above.
See this product’s row in the full ranking, alongside the other 153 scored products, or read what each of the five components asks and how to check it .
What this label discloses
Everything in this table is what the product itself states — on the printed panel, on the brand’s own page, or in the label record the manufacturer filed. Nothing in it is checked yet; checking is the next section.
| Disclosure | As recorded |
|---|---|
| CFU as printed | 5 billion CFU per 2-capsule serving (2.5 billion per capsule) |
| What that count is measured against | No basis stated |
| Strain designators | All organisms coded |
| Organism slots transcribed here | 1 — the full panel |
| Marketed as | Unisex |
(5B CFU per serving) — printed with no qualifier. Neither DSLD record adds one, and a token search of the live page for "at time of manufacture", "through expir", "until expir" and "guaranteed" returns nothing in a CFU context.
The panel’s own words on potency, verbatim.
A CFU number appears with no temporal basis of any kind. A count with no basis is not a quantity; there is no date at which it is claimed to be true.
Every organism on the panel carries a printed strain designator. Whether those designators lead anywhere is a separate question, answered below.
| Organism as printed | Designator as printed | Quantity as printed | What the designator resolves to | The query we ran |
|---|---|---|---|---|
| Lactobacillus plantarum (correct name: Lactiplantibacillus plantarum) | OM | 500 mg per 2-capsule serving (5 billion CFU) | No records | "Lactobacillus plantarum OM" |
What of that is verifiable
A disclosure is verifiable when a reader can open a record that neither we nor the brand controls and see the same thing. Below is every dated artefact this page rests on. What is absent from this list is not verified, however reasonable it sounds.
- NIH Dietary Supplement Label Database record — DSLD 320990 (opens in a new tab) captured Entered 2024-10-24, on-market, UPC 0 010709 984266. The current record — and the one printing the accelerometer patent number.
- NIH Dietary Supplement Label Database record — DSLD 284049 (opens in a new tab) captured Entered 2023-02-21, UPC 0 010709 984259. Prints the correct patent number, US 5895758 A.
- Photograph of the printed panel — Probiotic-Breakthrough-Supplements-Facts-07https://static-v1.cdn-bio.com/bio-shop/2025/split-tests/Probiotic-Breakthrough-Supplements-Facts-07.jpg — Address given, not linked: this site does not link out to the products it audits. captured The brand's own Supplement Facts JPEG, read directly and cross-checked against the DSLD record at the per-capsule level.
How many of its strains have a human trial for what it is sold for
Across the frozen founding cohort, 0 of 294 organism slots (0.0%) carry an organism with a human randomised controlled trial for any male-specific outcome. Not for this product — for all 27 of the founding teardowns, taken together. That is the number to hold against any men’s probiotic, including this one.
Two further founding-cohort figures for context: only 43 of 294 organism slots carry a strain with any human RCT at all under the exact code printed on the label, and only 2 of 27 products have a published human trial of the finished formula — the thing actually in the bottle. All three figures divide by the frozen cohort of 27 teardowns and 294 organism slots, never by every teardown on this site.
For this product specifically, 0 organism slots carry a strain with a human RCT under the exact designator printed on the label.
A word on what a designator has to clear before it counts here. The organism must be named with the exact strain code that appears in the trial, the trial must be in humans, and the code must return that trial when a reader searches it. A species name does not qualify: the trials in this field are of strains, and a species contains thousands of them.
What it costs per day
$2.50 a day at the dose the label itself instructs.
- Price
- $74.99 USD
- What that buys
- 120-capsule bottle (30 days at the panel's own four-capsule Per Day column)
- Price checked
- — the source we read it fromhttps://bioptimizers.com/shop/products/probiotic-breakthrough — Address given, not linked: this site does not link out to the products it audits.
What certification it holds, checked at the issuer’s own register
A badge on a bottle is a claim like any other. Every row below was checked — or not checked — at the certifier’s own public register, never at the badge. Across the frozen founding cohort, 2 of 27 products hold a certification we could confirm at the issuer — a founding-cohort figure, not a count over every teardown on this site.
| Programme | Status at the issuer | Checked |
|---|---|---|
| None claimed | Not checked | not checked |
None claimed
We have not queried this register for this product. It does not mean the product holds nothing.
A token census across the live page returns zero for COA, Certificate, third-party, third party, NSF, Informed, Labdoor, cGMP, GMP and tested. An icon asset named manufacturing-coa.png exists in the page's image set but is a 150x150 greyscale glyph, not a document. No certification is asserted, so there is nothing to verify.
How it differs from the same brand’s women’s version
Across the fourteen same-brand men’s-versus-women’s label diffs run inside the frozen founding cohort, zero men’s or default formulas contain a probiotic strain, identified by designator, that was selected on male-specific evidence. In eight of the fourteen the sex-specific differentiator is a botanical or a mineral, and in five of the fourteen the women’s SKU is better-specified, cheaper, or both — “better-specified” meaning the panel that discloses more, never the panel with more in it. The rule behind each of those counts, and all fourteen pairs classified against it , are published in full. Diffs run on teardowns added since sit outside this fourteen, and outside the sentence above.
This brand sells no women’s counterpart to this product, so there is no diff to run.
Every finding on this page, with the record behind it
Finding 1 wrong-patent-number-on-the-fda-filed-label
The 2024 government label record for this product prints, verbatim: "P3-OM is proteolytic probiotic with its own patent # US 5895858 A." US 5,895,858 is titled "Integrated accelerometer test system", assigned to Analog Devices Inc, priority 1997-03-10 — 278 occurrences of "accelerometer" in the document and zero of "plantarum". The correct number, printed on the brand's own 2023 record, is US 5,895,758, "Strain of lactobacillus Plantarum". A single transposed digit — but it is on the label, it is the version on file, and it is the one a consumer or reviewer would look up.
The record: DSLD 320990 versus DSLD 284049 · Google Patents US5895858A and US5895758A — open it (opens in a new tab)
Finding 2 new-patented-strain-where-the-patent-expired-in-2017
The live page markets a "New patented strain that helps support better protein digestion and assimilation". US 5,895,758 was filed 1997-06-10, granted 1999-04-20, and Google Patents records its legal status as "Expired - Lifetime" with an anticipated expiry of 2017-06-10. It is nine years out of force. Calling the strain "new" is not supportable; calling it "patented" is, at best, past tense.
The record: Google Patents US5895758A — open it (opens in a new tab)
Finding 3 label-points-at-a-patent-asserting-anti-tumoral-properties
US 5,895,758's abstract asserts the strain has "proteolytic, anti-viral, anti-retroviral, anti-bacterial, anti-microbial, and anti-tumoral characteristics and uses". Printing that patent number on a dietary supplement label, immediately adjacent to a structure/function claim, functions as a pointer to claims that could not lawfully be printed directly.
The record: Google Patents US5895758A — open it (opens in a new tab)
Finding 4 zero-human-trials-of-the-only-active-ingredient
Searched from four directions across PubMed and ClinicalTrials.gov. There is no human randomised controlled trial of Lactobacillus plantarum OM, for any outcome, in either database. The strain's patent inventor has no PubMed publications on it. Nine PubMed and PMC links appear in the page source; all are general probiotic, synbiotic and gut-barrier literature, and none is a trial of this strain.
The record: PubMed and ClinicalTrials.gov queries re-run 2026-07-30, all counts reproduced exactly
Finding 5 cfu-basis-unstated-and-the-bottle-carries-a-manufacture-date
The panel prints "(5B CFU per serving)" with no qualifier, and neither government record adds one. The FAQ says: "The date listed on the Probiotic Breakthrough is the MFD (Manufacturing Date)… The product expires 2 years after MFD." So the bottle is stamped with a manufacturing date and the consumer must add 24 months themselves. Printing MFD rather than a best-by date is legal; doing it while declining to state whether the CFU count is at manufacture or through expiry is the finding.
The record: DSLD 320990 · DSLD 284049 · brand FAQ, verified live 2026-07-30
Finding 6 panel-per-day-column-is-half-the-maximum-directed-dose
The Supplement Facts "Per Day" column declares 1 g — four capsules, 10 billion CFU. The directions, on the live page and on both government records, read: "Take 1-2 capsules with each meal and take 1-2 capsules at night before bed." Three meals plus bedtime at two capsules each is eight capsules a day, twenty billion CFU — double what the panel's own Per Day column declares.
The record: DSLD 320990 · brand page directions, verified live 2026-07-30
Finding 7 multi-strain-products-compete-claim-is-uncited
"We use only one strain of probiotics because it's a hyper-aggressive strain… Taking multiple or combined strains is not recommended since they can often compete against each other, don't survive the gastrointestinal tract, or upset the balance of the microbiome." No citation is offered for any part of that, and none was found. It is a marketing rationalisation of a single-ingredient formula presented as a scientific principle.
The record: bioptimizers.com product page, verified live 2026-07-30
Finding 8 leaky-gut-repair-and-virus-control-claims
"Probiotic Breakthrough can support the leaky gut repair process" and "Helps Maintain the Growth Control of Bad Bacteria, Viruses, and Yeasts in the Gut". "Leaky gut" is not an FDA-recognised disease, which is precisely why it is usable, but "repair process" implies treatment of a pathological state; and claiming control of viruses and yeasts implies antiviral and antifungal action. Read alongside the label's pointer to a patent asserting anti-viral and anti-retroviral properties, these are the highest-exposure claims on the page.
The record: bioptimizers.com product page, verified live 2026-07-30
Finding 9 vaginal-flora-claim-on-a-mens-list-regular
"Support healthy vaginal flora… As a powerful lactobacillus, Probiotic Breakthrough can support your vaginal flora and health." This product is routinely listed as a top men's probiotic.
The record: bioptimizers.com product page, verified live 2026-07-30
Finding 10 product-renamed-skus-unchanged
P3-OM is now marketed as Probiotic Breakthrough, and the original URL 301s and then 302s to the new handle. The rename is cosmetic at the fulfilment layer — every cart SKU still carries the old name. Any comparison table listing "P3-OM" and "Probiotic Breakthrough" as separate products is double-counting one SKU.
The record: bioptimizers.com redirect chain and cart SKUs, verified 2026-07-30
What we could not verify
Every gap below is published rather than deleted. Most are derived automatically from the empty fields in this page’s own record, so a gap cannot be hidden by leaving a box blank.
- None claimed status
- A token census across the live page returns zero for COA, Certificate, third-party, third party, NSF, Informed, Labdoor, cGMP, GMP and tested. An icon asset named manufacturing-coa.png exists in the page's image set but is a 150x150 greyscale glyph, not a document. No certification is asserted, so there is nothing to verify.
- The bottle price, at second hand
- The $74.99 published above was decoded from a base64 data-cart-item payload in the live page source during the teardown pass, alongside $21.99 for 30 capsules and $39.99 for 60. The audit did not re-decode those payloads, so the figure was read once and not re-checked — unreproduced rather than refuted.
- Which of the brand's two doses a cost per day should use
- The Supplement Facts "Per Day" column declares four capsules; the directions permit up to eight. The cost per day above uses the panel's own four-capsule column. At the maximum directed dose the 120-capsule bottle is a 15-day supply and the cost is $5.00 a day.
- Whether the strain multiplies in the gut as claimed
- "Can multiply inside your gut so you don't need as many colony-forming units (CFUs) as other probiotics" is uncited, and no supporting source was found. It is the load-bearing justification for a 5-billion-CFU product competing against 25–60-billion products, and as written it is unfalsifiable — it converts a low number into a feature.
- Material-connection disclosure for the page's testimonials
- The page is influencer- and testimonial-heavy. No material-connection disclosure was located. Recorded as not found, not as absent.
- Any CFU basis
- None is stated. The bottle is stamped with a manufacturing date rather than an expiry date and the FAQ tells the buyer to add two years themselves, so a buyer has no way to know what fraction of 5 billion is alive in the capsule being swallowed.
How to check every line of this page yourself
Nothing on this page requires trusting us. Every claim above resolves to a record you can open:
- Open the NIH Dietary Supplement Label Database record linked at the top of this page. It is the label the manufacturer filed, not our transcription of it.
- Compare the CFU line and the suggested-use line against the disclosure table above. If they disagree with us, we are wrong and we want to know.
- Take any strain designator from the panel and run the query printed beside it. The query is published precisely so you can get a different answer than we did.
- Divide the price by the number of days the label’s own dose instructions make the container last. That arithmetic is the whole of the cost-per-day row.
- Search the certifier’s own register for this product, not for the brand. A company can participate in a programme without this product being on its list.
Type the patent number off the label into Google Patents and you get an accelerometer test rig.
BiOptimizers files its label with the NIH Dietary Supplement Label Database, and the 2024 record — the current one — carries this sentence verbatim: “P3-OM is proteolytic probiotic with its own patent # US 5895858 A.” US 5,895,858 is titled Integrated accelerometer test system, assigned to Analog Devices Inc. The word “accelerometer” appears 278 times in it. The word “plantarum” appears zero times.
The strain patent is US 5,895,758 — one transposed digit — and the brand’s own earlier 2023 record prints it correctly. So this is a typo, not a fabrication. But it is a typo on the label, on the version the government holds, and it is the number a consumer or a reviewer would look up.
Look up the right one and a second problem appears. US 5,895,758 was filed in 1997 and expired in 2017. The live page markets a “New patented strain.”
And a third, which matters more than either. The product contains exactly one active ingredient: Lactobacillus plantarum OM. Searched from four directions across PubMed and ClinicalTrials.gov, there is no human randomised controlled trial of this strain, for any outcome. The sixteen PubMed hits for the strain name are pig fermentation, rat oral mucositis, mouse lysates, corn and grape silage, and one EPR-ENDOR physics paper. The patent’s inventor has no PubMed publications on it. Nine PubMed and PMC links appear in the page source; none is a trial of this strain.
What holds the whole value proposition up is a single uncited sentence: “Can multiply inside your gut so you don’t need as many colony-forming units (CFUs) as other probiotics.” No source is offered and none was found. It is also unfalsifiable as written — it converts a low number into a feature.
In fairness: the 365-day money-back guarantee is real and unusually generous, subscription pricing is shown side by side with one-time pricing on every bottle size at a modest and honestly labelled discount, and no forced-continuity language was found. On subscription mechanics this is the cleanest brand in its batch.