DRAFT MOCKUP, not live
Microbiome Restoration Protocol

Dysbiosis, addressed with one defined protocol.

A defined protocol, guided by precision testing: deep sequencing at baseline, a donor matched to your patient from that baseline, four bottles manufactured for your named patient, and follow-up sequencing at the end. The same steps for every case, so implementation stays simple and results are documented consistently.

The protocol at a glance

Microbiome Restoration Protocol

Who it’s for
Patients whose licensed practitioner has assessed them for dysbiosis and decided microbiome restoration is appropriate. Patient selection always remains the practitioner’s clinical decision.
What’s included
4 bottles, manufactured on demand for a named patient, plus a CM Bio baseline test, donor matching based on that baseline, and a CM Bio follow-up test using deep shotgun metagenomic sequencing.
Donor matching
Precision-matched FMT: your patient’s baseline sequencing is matched to a donor from our screened donor pool using our proprietary donor matching algorithm, designed for the best possible match.
Typical duration
A defined four-bottle protocol: recommended pre-treatment, three months of FMT, then a re-test one month after FMT ends.
Schedule
● Registered practitioners only
The full four-bottle schedule is in the Protocol Book, available after registration and login.
Phases
5 phases: Baseline test & match, Pre-treatment, Restore (three months), Re-test (one month after FMT), Maintain
Format
Predominantly oral capsules, or our patented oral powder for pediatric patients. No procedure suite required. (U.S. Patent No. 12,064,451)
What you receive
The Protocol Book, patient handouts, onboarding with Sarah, case support from our clinical team, and both sequencing reports.
Dosing
Dosing and administration are provided only inside the practitioner portal and determined by the treating practitioner.
● Pricing and specifications for registered practitionersRegister to view pricing →
Five phases

A protocol, not a one-time procedure.

Each phase has a clear purpose and a clear handoff. Our team is available at every decision point.

Phase 1

Baseline test & match

CM Bio deep shotgun metagenomic sequencing, then precision donor matching from the result.

Phase 2

Pre-treatment

Pre-treatment is recommended before FMT starts, directed by the practitioner. [verify: pre-treatment details, practitioner area]

Phase 3

Restore, three months

Three months of FMT: four bottles, manufactured per patient from the matched donor and shipped cold chain.

Phase 4

Re-test, one month after

CM Bio follow-up sequencing one month after FMT ends, compared against baseline.

Phase 5

Maintain

Ongoing support options chosen by the practitioner. [verify: postbiotic maintenance products, launch timing]

Illustrative structure only, not a recommendation. Dosing and timing are determined by the treating practitioner for the individual patient.

Precision donor matching

Not just any donor. A matched donor.

The protocol is the same for every case. The donor is not. Conventional FMT pairs any screened donor with any patient. Novel Biome matches the donor to the patient’s own baseline microbiome.

CONVENTIONAL FMT

One size fits all.

Any screened donor, any patient. The donor is chosen without looking at the patient’s own microbiome.

NOVEL BIOME / PRECISION DONOR MATCHING

The donor is matched to the patient.

Each patient’s baseline deep sequencing is matched to a donor using our proprietary donor matching algorithm, built on current microbiome science, which improves as more patients are treated. Designed for the best possible match, aiming for the best possible outcomes. [Foley Hoag: review “proprietary algorithm that improves as more patients are treated”]

01 / PATIENT PROFILE

Baseline sequencing

Deep shotgun metagenomic sequencing describes your patient’s gut microbial community before anything starts.

02 / DONOR POOL

Screened donors

Only donors who pass every round of safety screening enter the matching pool.

03 / MATCH

Proprietary matching algorithm

Built on current microbiome science and improving as more patients are treated, our algorithm matches the patient profile to a donor, designed for the best possible match.

04 / MANUFACTURE

Made for your patient

The four bottles are manufactured on demand from the matched donor, for your named patient, and released against specification.

Donor matching is part of how product is selected for each patient. It is not a diagnosis and does not predict an individual result. Clinical decisions remain with the treating practitioner.

Pre and post testing

Deep genome sequencing, at both ends.

Every protocol starts and ends with the same test, so you compare like with like.

BASELINE

CM Bio stool test, before

Deep shotgun metagenomic sequencing characterizes your patient’s gut microbial community before the protocol begins and is used to match them to a donor. You and your patient receive the report.

FOLLOW-UP

CM Bio stool test, after

The same sequencing after the course shows how the community has changed. You interpret it alongside your own clinical assessment.

WHO RUNS IT

Sequencing by CM Bio (Cmbio), a microbiome laboratory group. [verify: CM Bio description and naming approved by CM Bio]

ORDERING

Test kits are ordered through your practitioner account and can ship to the clinic or the patient.

PRICING

Test pricing, and how the baseline test applies toward the protocol, are shown to registered practitioners.

● Register to view pricing

Standardized outcome data

The same steps produce comparable records.

Because every case follows the same protocol and the same pre and post sequencing, practitioners can document cases consistently. A practitioner outcome tracking tool is being scoped for a later phase.

01

Same protocol

Four bottles, five phases, one Protocol Book, and donor matching for every patient.

02

Same test

CM Bio sequencing at baseline and follow-up.

03

Same record

A consistent case template for your notes. [outcome tracking app: scoping, not in this launch]

Formats

Oral first. No procedure required.

Manufactured for a named patient and shipped to the clinic or the patient’s door. Full specifications are in the practitioner portal.

Novel Biome oral capsules packaging. Photo from current novelbiome.com, to be replaced by Malin’s shoot.
Photo from current novelbiome.com, to be replaced by Malin’s shoot

Oral capsules

The predominant format. Taken at home on the practitioner’s schedule. No clinic visit, no sedation, no scope.

● Register to view pricing

Novel Biome oral powder packaging. Photo from current novelbiome.com, to be replaced by Malin’s shoot.
Photo from current novelbiome.com, to be replaced by Malin’s shoot

Patented oral powder

Mixed and taken by mouth, for pediatric patients. (U.S. Patent No. 12,064,451)

● Register to view pricing

StorageRefrigerated

Ideal for long-term storage.

ShippingCold chain

To the clinic or the patient’s door.

Shelf life2 years

From manufacture.

MadeOn demand

Per named patient. Nothing sits on your shelf.

Practitioner questions

Before you register.

Can I see pricing before registering?

Pricing for the protocol and CM Bio testing is shown only inside approved practitioner accounts. Registration takes a few minutes, and Sarah follows up to schedule your onboarding call.

Why one standardized protocol instead of condition-specific ones?

A single defined protocol is simpler to implement, easier to explain to patients and produces records that can be compared across cases. Patient selection remains your decision.

How is the donor chosen for my patient?

From your patient’s baseline CM Bio sequencing. Our proprietary donor matching algorithm matches that profile to a donor from our screened donor pool, designed for the best possible match. Matching happens quickly once baseline results are in, before the four bottles are manufactured. Practitioners do not receive donor details, but our team is happy to discuss the match with you. Clinical decisions remain with you.

Where is the dosing information?

In the Protocol Book inside the practitioner portal. Dosing is determined by the treating practitioner for the individual patient.

Who can order?

Licensed healthcare practitioners, after qualification and an onboarding call.