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Compositions and methods for improvement of iron metabolism and gut microbiome health

A composition and microbial technology, applied in drug combination, pharmaceutical formulation, food science, etc., can solve problems such as iron deficiency and treatment non-response

Pending Publication Date: 2021-03-19
SIDERO BIOSCI LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Additionally, many (indeed most) patients with iron deficiency do not respond to oral iron therapy, rendering them iron deficient

Method used

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  • Compositions and methods for improvement of iron metabolism and gut microbiome health
  • Compositions and methods for improvement of iron metabolism and gut microbiome health
  • Compositions and methods for improvement of iron metabolism and gut microbiome health

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0227] Figure 4 The experimental protocol is exemplified in . Figure 5 The study schedule is displayed in . Subjects were pre-screened and only non-anemic patients (hemoglobin >8 g / dL) were selected to participate in the study. All subjects were instructed to stop taking iron supplements and / or iron-containing multivitamins, if available, four weeks prior to study initiation.

[0228] Thirty-four subjects (demographics reported in Table 1) suffering from iron deficiency (transferrin saturation (TSAT) <20% and serum ferritin <50 ng / mL) were instructed to take 1.5 g of Composition A / day, provided as four 375mg capsules for two weeks. Ingest the capsules directly with water. The iron content in composition A is about 57 mg iron / gram of composition A, resulting in an initial intake level of 85.5 mg iron per day, which is an iron salt such as ferrous sulfate (per day 165-195mg) of approximately 50% of the daily recommended standard of care.

[0229] Table 1: Study Demograp...

Embodiment 2

[0279] Figure 28 The experimental protocol is exemplified in . Subjects were pre-screened and only non-anemic patients (hemoglobin >8 g / dL) were selected to participate in the study. All subjects were instructed to stop taking iron supplements and / or iron-containing multivitamins, if available, four weeks prior to study initiation.

[0280] Six non-pregnant, non-postpartum female subjects suffering from iron deficiency were instructed to take 3.0 g / day of Composition B, provided in eight 375 mg capsules, for twelve weeks. The composition A content is about 74 mg iron / gram, and the intake level is 222 mg iron per day, which is the daily recommendation for iron salts such as ferrous sulfate (165-195 mg per day) for subjects suffering from iron deficiency Approximately 114% of standard of care.

[0281] Tolerability of Composition B was monitored by direct questioning and recording of adverse events and by completing weekly gastrointestinal discomfort questionnaires.

[0282...

Embodiment 3

[0286]Using a standard preclinical animal model of iron deficiency, we demonstrate that ferritin-expressing, iron-supplemented yeast is superior to the standard regimen of administering ferrous sulfate to treat iron deficiency.

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Abstract

Disclosed is a composition comprising a microbe expressing ferritin. The composition also comprises elemental iron in an amount of at least 3% by weight on a dry matter basis of the microbe expressingferritin and the elemental iron. Also disclosed are ingestibles, dietary supplements, and pharmaceutical compositions comprising the composition. Also disclosed are methods for treating a subject comprising administering the composition to the subject. Also disclosed are methods of altering the composition of the gut bacterial microbiome in a subject, the method comprising administering the composition to the subject.

Description

[0001] cross reference [0002] This application claims priority to U.S. Provisional Application No. 62 / 680,238, filed June 4, 2018, entitled "Composition and Method for Treatment of Iron Deficiency." technical field [0003] The present disclosure relates to the management of nutrient deficiency and subsequent symptoms or diseases, and the management and modulation of the gut microbiome. Background technique [0004] Iron deficiency is the most common and prevalent nutritional disorder worldwide, affecting as many as 2 billion people. Iron is one of the most important non-organic substances in life and plays a major role in oxygen transport, short-term oxygen storage and energy production, which are some of its fundamental roles in biological physiology. Deficiency in iron absorption or excess iron loss results in suboptimal blood and / or tissue iron levels with a variety of symptoms. [0005] Current iron replacement options are clearly insufficient, and new strategies ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/26C12N1/19A61P25/28
CPCA61P25/28A61K33/26A23L33/14A23L33/16A23L33/165A23V2002/00A23L33/30A61K35/66A61K35/74A61K38/1709A61K45/06A61P7/06A23V2200/3204A23V2250/1592A23V2250/762A61K2300/00A23L33/17A61K36/06
Inventor D·沃尔夫詹姆斯·科纳
Owner SIDERO BIOSCI LLC
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