DELIVERING NON-PATHOGENIC, INTESTINALLY BENEFICIAL BACTERIA TO A PATIENT HAVING A FEEDING TUBE
Devices and methods for delivering non-pathogenic, intestinally beneficial bacteria to a patient having a feeding tube. Examples of non-pathogenic, intestinally beneficial bacteria that could be used include Bifidobacterium species and Lactobacillus species. In one embodiment, the bacteria is contained in a bacteria infusion device that comprises: (a) an internal chamber; (b) an outlet in communication with the internal chamber; and (c) the non-pathogenic, intestinally beneficial bacteria contained in the internal chamber. Another embodiment is a feeding tube comprising a flexible tubing and coating on the outer surface of the flexible tubing. The coating comprises an antimicrobial agent. Also disclosed are methods of administering a non-pathogenic, intestinally beneficial bacteria to a patient.
1 . A bacteria infusion device comprising:
an internal chamber;
an outlet in communication with the internal chamber; and
a non-pathogenic, intestinally beneficial bacteria contained in the internal chamber.
2 . The device of claim 1 , wherein the bacteria is a Bifidobacterium species.
3 . The device of claim 1 or 2 , wherein the bacteria is B. breve, B. longum , or B. pseudocatenulatum.
4 . The device of any one of claims 1 - 3 , wherein the bacteria is B. longum of subspecies infantis.
5 . The device of claim 1 , wherein the bacteria is a Lactobacillus species
6 . The device of claim 1 or 5 , wherein the bacteria is L. plantarum, L. pentosus, L. sahvarius, L. crispatus, L. sakei, L. antri , or L. coleohominis.
7 . The device of any one of claims 1 - 6 , wherein the amount of bacteria is 0.1 billion to 100 billion live colony forming units.
8 . The device of any one of claims 1 - 7 , further comprising a bacteria-preserving agent mixed with the bacteria.
9 . The device of claim 8 , wherein the bacteria-preserving agent is trehalose, sorbitol, albumin, polyethylene glycol, polyvinylpyrrolidone, milk fractions, dimethyl sulfoxide, or glycerol.
10 . The device of any one of claims 1 - 9 , wherein the bacteria is in a solid form.
11 . The device of any one of claims 1 - 9 , wherein the bacteria is in a liquid medium.
12 . The device of claim 11 , wherein the volume of liquid medium is in the range of 0.3 ml to 5 ml.
13 . The device of claim 12 , wherein the volume of liquid medium is about 0.5 ml, about 1 ml, about 1.5 ml, about 2 ml, about 2.5 ml, about 3 ml, about 3.5 ml, about 4 ml, about 4.5 ml, or about 5 ml.
14 . The device of any one of claims 1 - 13 , wherein the device further comprises a liquid medium which comprises a nutritional ingredient.
15 . The device of claim 14 , wherein the nutritional ingredient is an oil, a mammalian milk, or an artificial nutritional formulation.
16 . The device of claim 15 , wherein the oil is a triglyceride oil.
17 . The device of claim 16 , wherein the oil is a medium chain triglyceride oil.
18 . The device of claim 15 wherein the nutritional formulation comprises bacterial supernatant.
19 . The device of any one of claims 1 - 18 , wherein the bacteria has surface structures that internalize milk glycans or derivative monomers of milk glycans.
20 . The device of any one of claims 1 - 19 , further comprising an outlet fitting for coupling the outlet to a feeding tube.
21 . The device of any one of claims 1 - 20 , further comprising an inlet and an inlet fitting for coupling the inlet to an enteral feed source.
22 . The device of claim 21 , wherein the inlet fitting, outlet fitting, or both are standardized medical connection fittings.
23 . The device of claim 22 , wherein the medical connection fitting comprises a threaded lock.
24 . A feeding tube comprising:
a flexible tubing;
a feed port on the flexible tubing; and
a bacteria infusion device of any one of claims 1 - 23 coupled to the feed port.
25 . The feeding tube of claim 24 , wherein the feeding tube is a naso-gastric feeding tube.
26 . A feeding tube comprising:
a flexible tubing comprising an outer surface; and
a coating on the outer surface of the flexible tubing, the coating comprising an antimicrobial agent.
27 . The feeding tube of claim 26 , wherein the feeding tube is a naso-gastric feeding tube.
28 . The feeding tube of claim 26 or 27 , wherein the antimicrobial agent is a protein.
29 . The feeding tube of any one of claims 26 - 28 , wherein antimicrobial agent is a milk protein.
30 . The feeding tube of any one of claims 26 - 29 , wherein the antimicrobial agent is lactoferrin or lysozyme.
31 . The feeding tube of any one of claims 26 - 30 , wherein the antimicrobial agent is a naturally-occurring compound.
32 . The feeding tube of claim 31 , wherein the antimicrobial agent is allicin, catechin, citricidal, cinnamaldehyde, or carvacrol.
33 . The feeding tube of claim 26 or 27 , wherein the antimicrobial agent is a synthetic compound.
34 . The feeding tube of any one of claims 26 - 33 , wherein the antimicrobial agent is covalently immobilized to the outer surface of the flexible tubing.
35 . The feeding tube of any one of claims 26 - 34 , further comprising a bacteria infusion device of any one of claims 1 - 23 .
36 . A kit comprising:
a feeding tube, optionally according to any one of claims 24 - 35 ; and
a bacteria infusion device of any one of claims 1 - 23 .
37 . The kit of claim 36 , wherein the bacteria infusion device further comprises an outlet fitting for coupling the outlet to the feeding tube.
38 . A method of assembling the kit of claim 36 or 37 , wherein the bacteria infusion device has a proximal end and a distal end, the method comprising coupling the distal end to the feeding tube.
39 . The method of claim 38 , further comprising coupling the proximal end to an enteral feed source.
40 . A method of administering a non-pathogenic, intestinally beneficial bacteria to a patient having a feeding tube inserted into the gastrointestinal tract, the method comprising infusing a non-pathogenic, intestinally beneficial bacteria into the patient's gastrointestinal tract.
41 . The method of claim 40 , wherein the infusion of bacteria is performed through the feeding tube.
42 . The method of claim 40 or 41 , wherein the bacteria is in a liquid medium.
43 . The method of claim 42 , wherein the volume of liquid medium is in the range of 0.3 ml to 5 ml.
44 . The method of any one of claims 40 - 43 , further comprising, prior to use, storing the bacteria at a temperature that is below 20° C.
45 . The method of any one of claims 40 - 44 , further comprising repeating the step of infusing the bacteria into the gastrointestinal tract.
46 . The method of claim 45 , wherein continued infusion of bacteria is for the duration that enteral feeding is required.
47 . The method of claim 45 or 46 , wherein the repeated infusion is performed within 12 hours to 72 hours after the initial infusion.
48 . The method of any one of claims 40 - 47 , wherein the bacteria is infused simultaneously with infusion of an enteral feed.
49 . The method of any one of claims 40 - 48 , wherein the enteral feed comprises an oligosaccharide found in mammalian milk.
50 . The method of any one of claims 40 - 49 , further comprising coupling a bacteria infusion device of any one of claims 1 - 23 to the feeding tube, and wherein the bacteria and/or its supernatant is infused out from the internal chamber through the outlet.
51 . The method of claim 50 , further comprising coupling an enteral feed source to the bacteria infusion device.
52 . The method of claim 51 , further comprising infusing the enteral feed source through the bacteria infusion device and into the feeding tube.
53 . The method of claim 51 or 52 , further comprising detaching the bacteria infusion device after the enteral feed infusion is complete.
54 . The method of any one of claims 40 - 53 , wherein the feeding tube comprises:
an outer surface; and
a coating on the outer surface of the feeding tube, the coating comprising an antibacterial agent.
55 . The method of any one of claims 40 - 54 , wherein the patient is a preterm infant.