Methods and compositions for bowel cleansing before a medical procedure

• US 9,655,919 B2
• Filed: 07/09/2009
• Issued: 05/23/2017
• Est. Priority Date: 07/09/2008
• Status: Active Grant

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Korzenik, Joshua, Siegel, Corey A., Knuth, Douglas
• Primary Examiner(s): Ricci, Craig
• Application Number:
  US13/002,887
• Publication Number:
  US 20110288180A1
• Time in Patent Office: 2,875 Days
• Field of Search: None
• CPC Class Codes: A23L 2/52 Adding ingredients adding preservatives A23L2/44
• CPC Class Codes: A23L 33/10 using additives addition of substantially indigestible substances A23L33/21
• CPC Class Codes: A23L 33/30 Dietetic or nutritional methods, e.g. for losing weight A23L33/10 takes precedence
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A61K 31/765 Polymers containing oxygen
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61P 1/10 Laxatives

Abstract

Described are kits, food compositions and methods for cleaning the bowel, e.g., in preparation for a medical procedure, e.g., a diagnostic or treatment procedure, such as an endoscopic or surgical procedure, or radiologic imaging such as CT colography.

Claims

1. A method of preparing a subject for a colonoscopy, the method comprising providing to a subject in need thereof a plurality of food items to be ingested by the subject between 24 hours and 14 hours immediately prior to the colonoscopy,

wherein said food items comprise low fiber solid and liquid foods having incorporated therein an amount of a laxative agent comprising polyethylene glycol sufficient to induce in the subject the production of watery yellow stools with a light yellow effluent,

wherein said food items are prepared by mixing at least one food ingredient with polyethylene glycol, and

wherein said food items comprise a shelf stable mixture of said at least one food ingredient and said polyethylene glycol.

2. The method of claim 1, further comprising providing all beverages to be ingested by the subject during the 24 hours prior to the medical procedure, and wherein at least one of the beverages to be ingested by the subject during the 24 hours prior to the medical procedure comprises a laxative agent.

3. The method of claim 1, wherein the plurality of food items that are provided comprise all of the foods to be ingested by the subject during the 24 hours prior to the medical procedure.

4. The method of claim 3, wherein each of the food items comprises a total of 0-6 g fiber.

5. The method of claim 4, wherein each of the food items further comprises a total of 0.3-15 g Total Fats;

0-150 mg Cholesterol;

100-500 g of carbohydrates and 10-80 g of protein.

6. The method of claim 1, wherein the medical procedure is selected from the group consisting of colonoscopy, intestinal surgery, virtual colography, and barium studies.

7. The method of claim 1, wherein the polyethylene glycol is PEG 3350.

8. The method of claim 2, wherein all the beverages to be ingested by the subject during the 24 hours prior to the medical procedure have a total volume that is less than 2.5 liters.

9. The method of claim 2, wherein all the beverages to be ingested by the subject during the 24 hours prior to the medical procedure have a total volume that is less than 2 liters.

10. The method of claim 1, wherein the method does not include whole bowel irrigation.

11. The method of claim 1, wherein the food items comprise at least one liquid food item.

12. The method of claim 11, wherein the at least one liquid food item is a smoothie.

13. The method of claim 11, wherein no laxative agent other than the laxative agent mixed with food items is provided to the subject for ingestion prior to the procedure.

14. The method of claim 1, wherein the food items provide a delivery vehicle for the laxative agent.

15. The method of claim 1, wherein the method eliminates or reduces side effects associated with administering to the subject food and laxative separately.

16. The method of claim 1, wherein the side effects comprise one or more of dizziness, dehydration, nausea, vomiting, and taste fatigue.

17. The method of claim 1, wherein the at least one laxative is provided in an amount sufficient to induce the presence of watery yellow stools with light yellow or clear effluent within about 6-8 hours after ingestion of the at least one food item by the subject.

18. The method of claim 1, wherein the plurality of food items provide calories to the subject when ingested.