# US 2021/0239696 A1 · Method for measuring and improving gut health

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- Number: US 2021/0239696 A1
- Document ID: US20210239696A1
- Status: Published application
- Kind: A1
- Application number: 17/054,089
- Filed: 2019-05-09
- Published: 2021-08-05
- Earliest claimed: 2018-05-09
- Assignees: Carbiotix AB
- Applicants: Carbiotix AB
- Inventors: Peter FALCK; Kristofer COOK
- Web page: https://patentgrep.com/patent/US20210239696A1

## CPC

- G01N 33/56911: {Bacteria}
- A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 20/60: relating to nutrition control, e.g. diets
- G01N 2469/10: Detection of antigens from microorganism in sample from host
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to a method for measuring gut health comprising the steps of: a) collecting or receiving at least one, preferably two faecal samples, preferably three or more faecal samples from a human or animal, and the sample comprises markers; b) using the sample of step a), to generate output databased on a composition and/or function and/or metabolic activity of gut microbiota; c) measuring output data in relation to level and/or stability of one or more marker sand/or relation between different markers to generate a result on gut health.

## Claims

### Claim 1

Method for measuring gut health comprising the steps of:
a) collecting or receiving at least one, preferably two faecal samples, preferably three or more faecal samples from a human or animal, and the sample comprises markers;
b) using the sample of step a), to generate output data based on a composition and/or function and/or metabolic activity of gut microbiota;
c) measuring output data in relation to level and/or stability of one or more markers and/or relation between different markers to generate a result on gut health.

### Claim 2 (depends on 1)

Method according to claim 1, further comprising the step:
d) using the result on gut health to diagnose, prevent or treat disease, improve the quality of life, recommend a diet, lifestyle change, supplement or medication.

### Claim 3 (depends on 2)

Method according to claim 2, wherein the output data comprises quantities of at least one bacteria, gene and/or metabolite, preferably two, preferably three or more.

### Claim 4 (depends on 3)

Method according to claim 3, wherein the at least one bacteria are a member of the microbiota, preferably member of the fiber degrading or metabolizing bacteria, preferably belonging to Bacteroidetes, Firmicutes, Actinobacteria or Verrucomicrobia.

### Claim 5 (depends on 3)

Method according to claim 3, wherein the marker is gene activity or metabolic activity displayed by any of the microbiota members, preferably gene or metabolic activity related to fiber metabolism, preferably gene or metabolic activity related to short chain fatty acid biosynthesis, preferably gene or metabolic activity related to propionic and/or butyric acid production.

### Claim 6 (depends on 1)

Method according to claim 1, wherein one marker is used in conjunction with at least one other marker, preferably to monitor interactions between different bacteria, preferably to monitor cross-feeding interactions, preferably cross-feeding of organic acids such as short chain fatty acids and lactic acid between different bacteria, preferably cross-feeding interaction between acetate and lactic acid producing bacteria, and butyric producing bacteria, preferably cross-feeding interaction between Bifidobacterium or Lactobacilli and Faecalibacterium prausnitzii.

### Claim 7 (depends on 1)

Method according to claim 1, wherein the result is grouped into different categories based on results from an intervention with a fiber and/or probiotic and/or dietary change and/or lifestyle change to determine an individual's response and optimal gut health.

### Claim 8 (depends on 1)

Method according to claim 1, wherein the result is used to determine a baseline and/or an acute inflammation.

### Claim 9 (depends on 8)

Method according to claim 8, wherein a change in the level and/or stability and/or relation between different markers is indicative of inflammation in the host.

### Claim 10 (depends on 4)

Method according to claim 4, wherein the level of Faecalibacterium prausnitzii is used to indicate an optimal gut health in the intervals 50-0.1%, preferably 35-0.1%, preferably 20-0.5%.

### Claim 11 (depends on 4)

Method according to claim 4, wherein the level of Bifidobacterium is used to indicate an optimal gut health in the intervals 0.1-50%, preferably 1-50%, preferably 2-50%, preferably 5-50%, preferably 10-50%.

### Claim 12 (depends on 6)

Method according to claim 6, wherein the relation between Faecalibacterium prausnitzii and Bifidobacterium is used to indicate an optimal gut health and the ratio between Faecalibacterium prausnitzii and Bifidobacterium is between 100-0.01 preferably 50-0.02, preferably 25-0.04, preferably 10-0.1, preferably 5-0.2.

### Claim 13 (depends on 8)

Method according to claim 8, wherein the inflammation is indicative of development or onset of metabolic or chronic disease.

### Claim 14 (depends on 1, 13)

Method according to claims 1 and 13, wherein the results on gut health are used for diagnosis and/or prevention, and/or treatment of a disease, wherein the disease is selected from the group consisting of metabolic disease, gastrointestinal health, Crohn's disease, Ulcerative colitis, Multiple sclerosis, IBS, IBD, ADHD, Alzheimer's disease, muscle disease, non-alcoholic fatty liver disease, cardiovascular disease, allergy, asthma, diabetes, eczema and skin diseases, obesity, cancer, neurological health issues, endocrine system conditions, clostridium difficile associated conditions, locomotor system conditions, cutaneous condition, autoimmune system conditions, mental health associated conditions, skin related conditions, infectious disease and other health conditions associated with antibiotic usage, thyroid health issues, cerebro-craniofacial health, arthritis, dementia, and kidney disease.

### Claim 15 (depends on 1)

Method according to claim 1, wherein the result is used to base a recommendation, where in the recommendation is a healthier diet, preferably a more fiber-rich diet or a fiber supplement or a probiotic supplement or a medication.

### Claim 16 (depends on 1)

Method according to claim 1, wherein the recommended fiber supplement comprises non- or partially digestible polysaccharides and/or oligosaccharides and/or disaccharides consisting of modified or unmodified starch and partial hydrolysates thereof, inulin or partially hydrolyzed inulin, natural oligofructoses, fructo-oligosaccharides (FOS), lactulose, lactosucrose, soybean-oligosaccharides (SOS), galactomannan and suitable partial hydrolysates thereof, manno-oligosaccharides (MOS), indigestible polydextrose, acemannan, various gums and pectin and partial hydrolysates thereof, indigestible dextrin and partial hydrolysates thereof, trans-galacto-oligosaccharides (GOS), xylo-oligosaccharides (XOS), xylan, arabinoxylan, arabinogalactan, arabino-xylooligosaccharides (AXOS), beta-glucan and partial hydrolysates thereof, chito-oligosaccharides (COS), glucomano-oligosaccharides (GMOS), arabinooligosaccharides (AOS), pectin-oligosaccharides (POS), laminar-oligosaccharides, human milk oligosaccharides (HMO), bovine milk oligosaccharides (BOS), cellulose derived oligosaccharides.

### Claim 17 (depends on 10)

Method according to claim 10, wherein the level of Faecalibacterium prausnitzii is used to diagnose diabetes, where Faecalibacterium prausnitzii is less than 10%, more specifically less than 7%.

### Claim 18 (depends on 10)

Method according to claim 10, wherein the level of Faecalibacterium prausnitzii is used in the treatment of diabetes, where Faecalibacterium prausnitzii level is increased to more than is more than 7%, specifically more than 10%, specifically more than 14%.

### Claim 19 (depends on 10)

Method according to claim 10, wherein the level of Faecalibacterium prausnitzii is used to diagnose arthritis, where Faecalibacterium prausnitzii is less than 10%.

### Claim 20 (depends on 10)

Method according to claim 10, wherein the level of Faecalibacterium prausnitzii used in the treatment of arthritis, where Faecalibacterium prausnitzii level is increased to more than is more than 10%, specifically more than 14%.

### Claim 21 (depends on 11)

Method according to claim 11, wherein the level of Bifidobacterium is used to diagnose IBD, where the level of Bifidobacterium is unstable and is reduced below 4%, more specifically 3%, more specifically below 2%, more specifically in 3 month's time.

### Claim 22 (depends on 11)

Method according to claim 11, wherein the level of Bifidobacterium is used in the treatment of IBD, where the level of Bifidobacterium is stabilized above 2%, more specifically above 3%, more specifically above 4%.

### Claim 23 (depends on 10)

Method according to claim 10, wherein the level of Faecalibacterium prausnitzii is used to diagnose cutaneous condition, more specifically acne, where the level of Faecalibacterium prausnitzii is unstable and is reduced below 14%, more specifically in 3 month's time.

### Claim 24 (depends on 10)

Method according to claim 10, wherein the level of Faecalibacterium prausnitzii is used in the treatment of cutaneous condition, more specifically acne, where the level of Faecalibacterium prausnitzii is stabilized above 14%, more specifically in 3 month's time.

### Claim 25 (depends on 16, 17, 18, 19, 20, 21, 22, 23, 24)

Method according to any claim 17-24 where soluble fiber, more specifically soluble fiber mentioned in claim 16 is used to treat the aforementioned conditions in claims 17-24.