A dosage form contains a) a core, containing a biologically active ingredient, which is stable to a degree of at least 95% at a pH of 3 for 2 hours at 22° C.; b) an intermediate coating layer (ICL) onto or above the core, containing an alkaline agent; and c) an enteric coating layer (ECL) onto or above the intermediate coating layer, containing an enteric polymer. The relation in percent of the alkaline agent in the ICL to the enteric polymer in the ECL is 5 to 95% when calculated by the formula:

[00001]$\frac{\begin{array}{cc}\mathrm{quantity}\mathrm{of}\mathrm{alkaline}\mathrm{agent}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ICL}& \times 100\end{array}}{\left(\mathrm{quantity}\mathrm{of}\mathrm{alkaline}\mathrm{agent}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ICL}+\mathrm{quantity}\mathrm{of}\mathrm{enteric}\mathrm{polymer}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ECL}\right).}$

Compositions and methods for treating or preventing the progression of neurodegenerative diseases are provided herein. Exemplary compositions include bacterial compositions having an effective amount of viable, non-pathogenic microbes, viable, non-pathogenic bacteria, wherein at least one of the bacteria is a predatory bacteria such as Bdellovibrio bacteriovorus. The disclosed bacterial compositions can be used to treat or prevent the progression of neurodegenerative diseases such as ALS, Alzheimer's disease, Huntington's disease, and Parkinson's disease.

Compositions and methods for treating or preventing the progression of neurodegenerative diseases are provided herein. Exemplary compositions include bacterial compositions having an effective amount of viable, non-pathogenic microbes, viable, non-pathogenic bacteria, wherein at least one of the bacteria is a predatory bacteria such as Bdellovibrio bacteriovorus. The disclosed bacterial compositions can be used to treat or prevent the progression of neurodegenerative diseases such as ALS, Alzheimer's disease, Huntington's disease, and Parkinson's disease.

A composition of fecal material is prepared and administered to a subject suffering from alcohol craving, alcohol consumption and/or alcohol use disorder. The donor fecal material is enriched in beneficial microbiota associated with reduced alcohol craving and/or consumption and supplies beneficial microbiota in which the recipient is deficient, and reduces harmful microbes. Methods of preparing and administering are disclosed, along with the identification of beneficial and harmful microbiota families. The treatment is also useful for delivery of microbiota that are short chain fatty acid producers to reduce alcohol craving and/or consumption in subjects deficient in short chain fatty acids.

A composition of fecal material is prepared and administered to a subject suffering from alcohol craving, alcohol consumption and/or alcohol use disorder. The donor fecal material is enriched in beneficial microbiota associated with reduced alcohol craving and/or consumption and supplies beneficial microbiota in which the recipient is deficient, and reduces harmful microbes. Methods of preparing and administering are disclosed, along with the identification of beneficial and harmful microbiota families. The treatment is also useful for delivery of microbiota that are short chain fatty acid producers to reduce alcohol craving and/or consumption in subjects deficient in short chain fatty acids.

The present disclosure relates to methods and products for reducing side effects associated with immunotherapy using immune agonist antibodies. In certain embodiments, the present disclosure provides a method of reducing one or more side effects associated with immunotherapy using an immune agonist antibody alone, or in combination with an immune checkpoint inhibitor, in a subject suffering from a cancer, the method comprising modifying the gut microbiota in the subject and thereby reducing the one or more side effects associated with the immunotherapy in the subject.

The present disclosure relates to methods and products for reducing side effects associated with immunotherapy using immune agonist antibodies. In certain embodiments, the present disclosure provides a method of reducing one or more side effects associated with immunotherapy using an immune agonist antibody alone, or in combination with an immune checkpoint inhibitor, in a subject suffering from a cancer, the method comprising modifying the gut microbiota in the subject and thereby reducing the one or more side effects associated with the immunotherapy in the subject.

The subject invention provides compositions and methods for treating human dermatological conditions by employing a microbiome-centered treatment approach. Preferred embodiments of the invention provide pharmaceutical and cosmetic compositions, and the methods of using the same, comprising a strain of Lactobacillus fermentum bacterium, or bioactive extracts thereof, derived from human microbiota and capable of growing in biofilm phenotype.

The subject invention provides compositions and methods for treating human dermatological conditions by employing a microbiome-centered treatment approach. Preferred embodiments of the invention provide pharmaceutical and cosmetic compositions, and the methods of using the same, comprising a strain of Lactobacillus fermentum bacterium, or bioactive extracts thereof, derived from human microbiota and capable of growing in biofilm phenotype.

Disclosed herein are methods of terminally sterilizing bacterial minicells or compositions comprising bacterial minicells by exposure to ionizing irradiation. Also disclosed are terminally sterilized bacterial minicells, pharmaceutical compositions comprising the bacterial minicells, and methods of use the bacterial minicells and pharmaceutical compositions.