# US 11,439,674 B2 · Use of lactic acid bacteria to treat or prevent at least one of postnatal depression and postnatal anxiety

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- Number: US 11,439,674 B2
- Document ID: US11439674B2
- Status: Granted
- Kind: B2
- Application number: 16/617,813
- Filed: 2017-06-02
- Published: 2020-06-18
- Granted: 2022-09-13
- Earliest claimed: 2017-06-02
- Assignees: University of Otago
- Applicants: University of Otago
- Inventors: Rebecca Slykerman; Edwin Arthur Mitchell; Thorsten Villiers Stanley
- Web page: https://patentgrep.com/patent/US11439674B2

## CPC

- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A23L 33/135: Bacteria or derivatives thereof, e.g. probiotics
- A23L 33/21: Addition of substantially indigestible substances, e.g. dietary fibres
- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- C12N 1/205: Bacterial isolates
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A23V 2400/175: Rhamnosus
- C12R 2001/225: Lactobacillus
- 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)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- C12R: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS

## Abstract

The present invention provides methods of treating or preventing at least one of postnatal depression (PND) and postnatal anxiety (PNA), and risks and sequelae thereof, by administering Lactobacillus rhamnosus HN001 or derivatives thereof, in addition to uses, compositions, and medicaments comprising Lactobacillus rhamnosus HN001 or derivatives thereof to treat or prevent at least one of PND and PNA, and risks and sequelae thereof.

## Claims

### Claim 1

A method of treating or reducing the risk of preventing at least one of postnatal depression (PND) and postnatal anxiety (PNA) in a human adult female subject in need thereof, the method comprising administration of an effective amount of Lactobacillus rhamnosus HN001, deposited at the Australian Government Analytical Laboratories (AGAL) on Aug. 18, 1997, under deposit number NM97/09514, to the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the method comprises administering a composition comprising the L. rhamnosus HN001 and a physiologically acceptable diluent, adjuvant, carrier or excipient.

### Claim 3 (depends on 1)

The method of claim 1, wherein the method comprises administering a food composition comprising the L. rhamnosus HN001.

### Claim 4 (depends on 3)

The method of claim 3, wherein the food composition is selected from cultured milk, yoghurt, cheese, milk drink and milk powder.

### Claim 5 (depends on 1)

The method of claim 1, wherein the method comprises administering a pharmaceutical composition comprising the L. rhamnosus HN001 and a pharmaceutically acceptable diluent, adjuvant, carrier or excipient.

### Claim 6 (depends on 1)

The method of claim 1, wherein the method comprises administering a composition comprising the L. rhamnosus HN001, wherein the composition is a maternal formula, a maternal supplement, or a dietetic product.

### Claim 7 (depends on 1)

The method of claim 1, wherein the L. rhamnosus HN001 is in a reproductively viable form.

### Claim 8 (depends on 1)

The method of claim 1, wherein the L. rhamnosus HN001 is killed, lysed, fractionated or attenuated.

### Claim 9 (depends on 1)

The method of claim 1, wherein the subject has an increased risk of at least one of PND or PNA.

### Claim 10 (depends on 9)

The method of claim 9, wherein one or more factors leading to the increased risk are selected from prenatal depression or anxiety, a personal or family history of depression, moderate to severe premenstrual symptoms, maternity blues, birth-related psychological trauma, birth-related physical trauma, previous stillbirth or miscarriage, formula-feeding rather than breast-feeding, cigarette smoking, low self-esteem, childcare or life stress, low social support, poor marital relationship or single marital status, low socioeconomic status, infant temperament problems and colic.

### Claim 11 (depends on 1)

The method of claim 1, wherein the subject is pregnant and the L. rhamnosus HN001 is administered after the first trimester of pregnancy.

### Claim 12 (depends on 1)

The method of claim 1, wherein the subject is pregnant and the L. rhamnosus HN001 is administered between 14 and 16 weeks gestation.

### Claim 13 (depends on 1)

The method of claim 1, wherein the subject is pregnant and the L. rhamnosus HN001 is administered from 14 to 16 weeks gestation until delivery.

### Claim 14 (depends on 1)

The method of claim 1, wherein the subject is pregnant and the L. rhamnosus HN001 is administered from 14 to 16 weeks gestation to 6 months post- partum.

### Claim 15 (depends on 1)

The method of claim 1, wherein the method further comprises simultaneous or sequential administration of a prebiotic.

### Claim 16 (depends on 15)

The method of claim 15, wherein the prebiotic comprises fructooligosaccharides, galactooligosaccharides, or human milk oligosaccharides, or a combination thereof.

### Claim 17 (depends on 1)

The method of claim 1, wherein administration of the L. rhamnosus HN001 results in a score of less than 13 in the Edinburgh Postnatal Depression Scale (EPDS).

### Claim 18 (depends on 1)

The method of claim 1, wherein administration of the L. rhamnosus HN001 results in a score of less than 15 in the Stategrait Anxiety Inventory, 6 item version (STAI-6).

### Claim 19 (depends on 1)

The method of claim 1, wherein
the subject is pregnant,
the subject is pregnant and is 35 years or older,
the subject is pregnant and has a history of at least one of PND and PNA, or
the subject is pregnant, is 35 years or older, and has a history of at least one of PND and PNA.

### Claim 20

A method of reducing one or more risks associated with, or sequelae, at least one of postnatal depression (PND) and postnatal anxiety (PNA) in a human fetal, neonatal, infant, or child subject in need thereof, the method comprising administration of an effective amount of Lactobacillus rhamnosus HN001, deposited at AGAL on Aug. 18, 1997 under deposit number NM97/09514 dated 18 Aug. 1997, to the mother of the human fetal, neonatal, infant, or child subject.

### Claim 21 (depends on 20)

The method of claim 20, wherein
the subject is a fetal subject and the L. rhamnosus HN001 is administered to the subject's mother, or
the subject is a neonatal, infant, or child subject, and the L. rhamnosus HN001 is administered to the subject's mother.

### Claim 22 (depends on 20)

The method of claim 20, wherein the one or more risks associated with, or sequelae of, at least one of PND and PNA in the fetal, neonatal, infant, or child subject are selected from higher rates of emotional problems, behavioural problems, psychiatric diagnoses, and hyperactivity.
