METHODS AND COMPOSITIONS RELATED TO GUT TRANSIT MEASUREMENT

Abstract

Disclosed herein are methods and compositions related to determining gut transit time. The composition comprises a blue dye, which can be used to measure transit time from consumption to elimination as a waste product.

Claims

1. A composition for measuring gut transit time, the composition comprising: a. 3 egg whites from large eggs (100 ml/99 grams) or other equal protein amount b. ½ teaspoon cream of tartar c. 1 tablespoon sugar d. 2 tablespoons jam e. 2 tablespoons of Gluten-Free Flour or other substitute of equal caloric amount f. 1½ teaspoons soy, whey or other equal protein g. 1 teaspoon blue food coloring

2. The composition of claim 1, wherein the jam is a seedless fruit jam.

3. A method for preparing the composition of claim 1, the method comprising pre-heating an oven to 350° F., beating egg whites with cream of tartar and sugar for 1 minute or until soft peaks form; add jam and continue to beat for 30 seconds; add flour 1 tablespoon at a time and beat for a full minute after each addition; add protein powder and beat until incorporated; pouring into oven-safe container; cook 30 minutes or until kitchen thermometer reads 206° F.

4. A method of determining gut transit time, the method comprising feeding a subject the composition of claim 1, and determining when the composition has been eliminated by monitoring the subject's stool until blue color is seen.

5. A kit comprising at least two of the ingredients used to make the composition of claim 1.

Description

BRIEF DESCRIPTION OF FIGURES

[0011] FIG. 1 shows a graph of transit times in patients, and corresponds to Table 3.

[0012] FIG. 2A-B shows blue cake before and after baking.

[0013] FIG. 3 shows average time from ingestion to stooling, as measured by blue cakes.

[0014] FIG. 4A-E shows (A) process of obtaining information and measuring transit time; (B) transit time measurements; (C) distribution of the four transit time classes; (D) Bristol stool types; and (E) bowel movements.

DETAILED DESCRIPTION

[0015] The disclosed composition and method is a straightforward approach that allow for the evaluation of both children and adults for their entire gut transit. This is done by swallowing of 2 blue dye muffin meals that can then be detected in the stool once patient has a bowel movement. This new technique is more easily ingested by patients who have GI motility disorders with symptoms of abdominal pain, nausea, vomiting, diarrhea or constipation. This is derived from the study done in patients who had short gut syndrome and who were given this diet meal to evaluate the gut transit through the ostomies. This new technique can be done in both pediatrics and adults, and does not lead to capsule retention, and has the added advantage of not exposing patients to radioactive material.

[0016] The disclosed “blue muffin meal” mechanism for studying gut transit avoids the high cost of testing, is a more tasty option for patients with disturbed gut health and for healthy subjects and allows for mass production in several facilities around the country. These methods are compared below in Table 1.

TABLE-US-00001 TABLE 1 Methods of Determining Gut Transit Time Test Method Limitations Radiology Plain x ray Radiation exposure Barium with small bowel For Cine-MRI - follow through (SBFT) Validation of clinical Computerized tomography utility pending (CT)-CTE (Cost?0 Cine-MRI *Whole gut scintigraphy *only Scintigraphy is validated for whole gut transit Conventional/ Multi-lumen catheter Low specificity and High (Water perfused or solid invasive Resolution state) Not standardized Manometry Determines if neurogenic Requires trained or myogenic expertise in motility Can determine obstruction Poor correlation with from motility disorder histopathology Picks up artifacts (cardiac or pulmonary) High cost Wireless motility Determines intraluminal Risk of capsule capsule pressure and pH (transit) - retention Whole gut transit and small Contraindicated if bowel transit Crohns or hx 15%-30% of patients with obstruction or gastroparesis have colonic dysphagia transit or small bowel High Cost transit abnormalities Breath testing Not validated for colonic Not gold standard transit FDA approved in Children for gastric transit only. Radioopaque Not validated for stomach Radiation exposure and markers or small bowel transit not valid for stomach or bowel transit Histopathology Full thickness small bowel London Classification biopsy, stomach or colon only. No clinical biopsy is invasive and has consensus reached but to be done surgically evolving technique (can differentiate myopathy, neuropathy, from loss of ganglion or decrease and ICC loss) Invasive

[0017] Disclosed herein is a composition for measuring gut transit time, the composition comprising: 3 egg whites from large eggs (100 mL/99 grams); ½ teaspoon cream of tartar; 1 tablespoon sugar; 2 tablespoons jam (can be any flavor, preferably fruit jam, one example is seedless raspberry jam); 2 tablespoons of Gluten-Free Flour (one example is King Arthur Brand); 1½ teaspoons soy or whey protein; and 1 teaspoon blue food coloring. This composition can be referred to as “blue muffins.”

[0018] The composition disclosed herein can be made using the following method: pre-heating the oven to 350° F., beating egg whites with cream of tartar and sugar for 1 minute or until soft peaks form; add jam and continue to beat for 30 seconds; add flour 1 tablespoon at a time and beat for a full minute after each addition; add protein powder and beat until incorporated; pouring into oven-safe container; cook 30 minutes or until kitchen thermometer reads at least 206° F.

[0019] It is noted that 1 teaspoon of blue food coloring (also referred to herein as dye) is a significantly higher amount than that found in typical recipes for an added food coloring. It is surprising and unexpected that one can best determine transit time using this amount of food coloring.

[0020] The method and composition disclosed herein can be used to measure gut transit time. This method can comprise administering by feeding to a subject the composition disclosed herein, and determining when the composition has been eliminated as waste by monitoring the subject's stool until first blue color is seen (whole gut transit) and all subsequent blue stools (lag phase). Whole gut transit can help to determine if the subject is suffering from gastroparesis, for example while lag phase provides a measure of whole gut emptying. It is noted that the composition disclosed herein is not inflammatory and can be used as part of a “gastroparesis diet.”

[0021] Gastroparesis is a condition that affects the normal spontaneous movement of the muscles (motility) in the stomach. Ordinarily, strong muscular contractions propel food through your digestive tract. But with gastroparesis, this movement is slowed down or doesn't work at all, preventing proper emptying and leading to symptoms such as nausea, vomiting, stomach pain, distension and fullness with bloating and constipation.

[0022] Gastroparesis can be caused by diabetes. It can also be present in a subject after surgery or due to vital illnesses. Certain medications, such as opioid pain relievers, some antidepressants, and high blood pressure and allergy medications, can lead to slow gastric emptying and cause similar symptoms. Diabetes is another common cause of gastroparesis. Gastroparesis may also be linked to gastrointestinal distress common in Autism Spectrum Disorders.

[0023] Gastroparesis can interfere with normal digestion, cause nausea, vomiting, abdominal pain and constipation. It can also cause problems with blood sugar levels and nutrition.

TABLE-US-00002 TABLE 2 NUTRITIONAL COMPONENTS OF BLUE MUFFINS Egg Protein white Sugar Jam Flour powder Butter/oils Totals Carbs 45 100 38.7 183.7 Protein 51 1.6 10 62.6 Fat 5.1 5.1 Fiber 3.2 3.2 Total 254.6

TABLE-US-00003 TABLE 3 BLUE MARKER TRANSIT TIME IN MINUTES Blue Marker Blue Marker Blue Marker (fasted + (fasted + Patient (fasted) breakfast) lactulose) 1 ND 53 60 ND 50 ND 2 ND 60 70 ND ND ND 3 70 175 65 70 60 30 4 10 50 65 30 180 10 5 35 125 75 210 60 430 6 320 NS 535 406 513 250 7 ND NS NS ND NS ND 8 ND 1685 NS ND 720 NS ND: not done; NS: not seen. Note that patients 1, 2, 7, and 8 did not participate in the study with blue marker fasted.

[0024] It will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the invention. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the methods disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.