Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Group 1: Participant was on antibiotics anytime during the past 2 weeks prior to the time of enrollment.

Tongue assessment, stool sample, and questionnaires done at baseline and once during Days 3-7 and once during Days 8-12.

Participants wear a Holter monitor for 20-24 hours at baseline and once during Days 3-7 and once during Days 8-12.

Participants given 2 tablespoons (33 cc) of yogurt each day for 12 days.

Group 2: Participant has not been on antibiotics in the past 2 weeks.

Tongue assessment, stool sample, and questionnaires done at baseline and once during Days 3-7 and once during Days 8-12.

Participants wear a Holter monitor for 20-24 hours at baseline and once during Days 3-7 and once during Days 8-12.

Participants given 2 tablespoons (33 cc) of yogurt each day for 12 days.

The coating on the top of the tongue assessed and categorized into three categories: no coating, thin coating and thick coating. The coating of the tongue may be related to the microorganisms in the intestine.

Tongue Assessment

Stool sample collected at baseline and once during Days 3-7 and once during Days 8-12.

Stool Sample

Participants complete 4 questionnaires about symptoms in the past 24 hours, irritable bowel syndrome (IBS), most recent stool, and quality-of-life. Questionnaires completed at baseline and once during Days 3-7 and once during Days 8-12. Questionnaires should take about 30 minutes total to complete.

Questionnaires

Participants wear a Holter monitor for 20-24 hours to check nervous system and heart function at baseline and once during Days 3-7 and once during Days 8-12.

Holter Monitor

Participants given 2 tablespoons (33 cc) of DannonÒ OikosÒ yogurt each day for 12 days.

Yogurt

An T. Ngo-Huang

The goal of this clinical research study is to learn if probiotics found in yogurt can help to decrease gastrointestinal (GI) symptoms in cancer patients. Probiotics are live bacteria and yeast that help with many of our functions and may help digestive problems. Researchers also want to learn if the bacteria in your stool change as your symptoms change while eating yogurt.

Baseline Tests:

If you agree to take part in this study, you will have the following tests and procedures when you enroll:

* The coating on your tongue will be checked. Researchers think that the thickness of the coating on your tongue may be related to the microorganisms in your stomach and/or intestines.
* A stool sample will be collected for bacteria testing.
* You will be asked about your diet and how often you eat yogurt.
* You will wear a monitoring device called a Holter monitor for 20-24 hours to check your nervous system and heart function.
* You will be asked to complete 4 questionnaires about your symptoms in the past 24 hours, your irritable bowel syndrome (IBS), your most recent stool, and your quality-of-life. These questionnaires should take about 30 minutes total to complete.

Study Procedures:

One (1) time during Days 3-7 and 1 time during Days 8-12:

* You will be asked to complete the same 4 questionnaires you completed at baseline.
* A stool sample will be collected by your bedside nurse for bacteria testing.
* You may wear a Holter monitor to check your heart function.

You will be given at least 2 tablespoons (33 cc) of DannonÒ OikosÒyogurt each day.

Length of Study:

Your participation in this study will be over after you complete the study procedures during Days 8 to 12.

If you are discharged before you complete the study procedures above, you will be called and asked about your symptoms and given a stool collection kit. This phone call should take about 30 minutes to complete. The study staff will give you more information about stool collection. Your sample will be collected for bacteria testing at your next clinic visit.

This is an investigational study. The use of probiotics in yogurt to treat GI symptoms in cancer patients is investigational. The study doctor can explain how the probiotics are designed to work.

Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms

Adherence rate calculated as percentage of times that a participant takes at least 2 table spoon (30 cc) of yogurt/day consumed for the 10±2 day prescription, as well as for the first 5±2 days, and will be summarized for each group using descriptive statistics. Regimen considered feasible for each group if at least 70% of participants in that group have reached at least 70% adherence rate in 10±2 days.

M.D. Anderson Cancer Center

Symptoms and General Pathology

All Conditions

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Neoplasms

Syndrome

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Neoplasms, Second Primary

Micronutrients

Trace Elements

175g probiotic yogurt / day 25% RDA for each nutrient

Probiotic Yogurt B: with various micronutrients

175g probiotic yogurt/ day 25% RDA for each nutrient

Probiotic Yogurt A: Kaiser micronutrients

175g yogurt/ day 25% RDA for each nutrient

Probiotic yogurt C: with basic micronutrients

Probiotic Yogurt D: Placebo -- no added micronutrients

Gregor Reid, PhD

We hypothesize that micronutrient fortified probiotic yogurt can improve nutritional status and enhance immunity parameters in subjects HIV/AIDS and other immunodeficiencies.

We have developed a micronutrient-fortified probiotic yogurt that has safe and beneficial levels of micronutrients for human consumption. This has been undertaken with the guidance of Edward Farnworth, a senior research scientist at Agri-Food Canada-Food Research and Development Centre, St. Hyacinthe, Quebec

We will now measure nutritional parameters (height, weight, serum albumin, serum nutrient levels, blood urea, liver function tests (AST, ALT)) to determine if there is a statistically significant difference between the various levels of fortified probiotic yogurt and the placebo on the nutritional parameters of the subjects consuming the yogurt.

We will measure immunological parameters (CD4 lymphocyte count, CBC, levels of TNFα, IL-12, IL-10, and G-CSF \[Kim, et.al. 2006\]) in order to determine if there is a statistically significant difference using fortified probiotic yogurt compared to a placebo.

In addition, we will determine if the micronutrient-fortified probiotic yogurt has a significant impact on the overall quality of life for the subjects using the "linear analogue self assessment" tool \[Kaiser, et.al 2006\].

Drs. Reid and Hekmat have recently developed a fermented milk product (yogurt) containing Lactobacillus GR-1 and RC-14 and concluded that such dairy products are suitable vehicles for these beneficial microorganisms \[Hekmat, S. \& Reid, G. 2006\].

The strains Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 have a proven efficacy to treat and protect against gastrointestinal and urogenital infections \[Anukam, K. et. al. 2006; 2007\]. In one study, the supplementation of yogurt with these probiotics was shown to eradicate diahrea and increase the CD4 T-lymphocyte counts in HIV subjects \[Anukam, K. et.al. 2006\]. HIV infected subjects often suffer diarrheal episodes, and consequently experience malabsorption of certain nutrients \[Cunningham-Rundles, 2000\]. A study conducted by Cunningham et. al \[2000\] found that probiotic Lactobacillus plantarum 299 had a positive impact on the immunity of 10/17 children and on the growth of all of the children who were HIV-positive.

It is estimated that 75 percent of immune function is localized in the gastrointestinal tract, which may explain why oral administration of probiotics is an excellent tool for immunomodulation \[Olah, A. et. al. 2002\]. In a study of 45 patients with acute pancreatitis, 22 were given probiotic Lactobacillus plantarum 299 and 10g of oat fibre with regular enteral nutrition; and 23 were given a placebo in the form of regular enteral nutrition. Significantly fewer (n=1 versus n=7) patients in the probiotic/fibre group experienced septic complications requiring surgery, highlighting the safety and potential hospitalized benefits that could be accrued for critical care nutrition.

A study has recently shown in 40 HIV-infected patients taking a stavudine and/or didanosine-based HAART regimen plus micronutrients twice daily for twelve weeks, that the absolute CD4 count increased by an average of 24% versus 0% in the placebo group (p=0.01). The mean HIV-1 RNA decreased in the micronutrient supplementation group \[Kaiser, et.al. 2006\]. This is significant for the HIV/AIDS pandemic in Africa and for the many people in Canada living with HIV/AIDS. In addition, this may be related to other immunodeficiencies in hospitalized patients from chemotherapeutic and radiological treatments, organ transplantation, controlling diabetes, and other chronic ailments.

Clinical malnutrition is a heterogenous group of disorders including macronutrient deficiencies that lead to body cell mass depletion and micronutrient deficiencies, and these often coexist with infectious and inflammatory processes \[Hughes,S. \& Kelly, P. 2006\]. Diverse factors affect bioavailability, such as the nutritional status of individuals, the presence in the diet of substances which facilitate or inhibit its absorption, interactions among micronutrients, illnesses, and chemical characteristics of the compound used for fortification. There is good evidence that specific micronutrients, particularly zinc and vitamin A, influence immunity, while iron supplementation is often not effective in Africa \[Hughes, S. \& Kelly, P. 2006\].

More than 20% of older adults may have marginal or frank vitamin B12 deficiency \[Park, et.al. 2006\], while folic acid is often deficient in children and reproductive aged females. Glutamine, arginine, fatty acids, and vitamin E provide additional benefits to immunocompromised persons or patients who suffer from various infections, while long-chain polyunsaturated n-3 fatty acids, vitamin E, vitamin C, selenium, and nucleotides can modulate immunity to fight infection \[Field, et.al. 2002\]. In order to produce energy, the use of glucose by nervous tissue requires vitamin B1; this vitamin modulates cognitive performance, especially in the elderly. Vitamin B9 preserves brain during its development and memory during ageing. Vitamin B6 is likely to benefit in treating premenstrual depression. Vitamins B6 and B12, among others, are directly involved in the synthesis of some neurotransmitters \[Bourre, JM. 2006\]. Thus, three formulations added to L. rhamnosus GR-2 supplemented yogurt, will be tested at the Brescia College Tasting Centre where volunteers will score the products for taste and texture \[Hekmat, S. \& Reid, G. 2006\]

Thirty test subjects will be recruited during the first four months of the study, for inclusion in a trial starting at the 4-6 month time-point, with completion by 10-12 months. A crossover study will be performed in London in which 10 HIV positive volunteers with CD4 counts between 200 and 400 on their standard treatment (including Highly Active Antiretroviral Therapy), and 10 subjects with Cancer who are in the recovery stages and not currently receiving chemotherapy or radiation therapy, and 10 healthy adults (aged 18-30) will randomly be assigned to receive one cup of Yogurts 1, 2 or 3 and a control unsupplemented yogurt 4, daily for one month, followed by a two week washout where no yogurt will be consumed, then one month on the second yogurt, two weeks off etc for 162 days. Subjects will not be receiving antibiotics, not have any mental illness that would affect compliance, or not be requiring surgery during the study. No restrictions will be placed on subjects continuing prescribed or other remedies, but none will consume any other probiotic product during the study. The volunteers will be gender matched and a randomization scheme will ensure that subjects are blinded and different yogurts are distributed at each time (thus, for example two subjects will receive yogurt 1, two yogurt 2, three yogurt 3 and three yogurt 4 on day sample day one). The two week washout period will be used, as probiotic organisms do not persist for longer than that. Various measurements will be taken on the day of consuming the first and last batches of yogurt (days 0, 30, 44, 74, 88, 118, 132, 162). These will include weight, height, and from blood samples the CD4 count, CBC, levels of TNFα, IL-12, IL-10 and G-CSF \[Kim, et.al. 2006\], liver function test (AST, ALT), serum albumin, total protein, blood urea, serum zinc levels, serum selenium levels and HIV-1 RNA. A linear analogue self-assessment tool will be used to assess the subject's energy levels, daily activities and overall quality of life \[Kaiser, et.al. 2006\].

The present project is an important step in developing new yogurts, supplemented with micronutrients and probiotic lactobacilli for malnourished children, adults, and seniors in Canada, as well as surgical, transplant, and hospitalized patients, and HIV/AIDS subjects in Canada and in Africa. The following formulations will be used to supplement the yogurt:

1. The Kaiser micronutrient formula \[14\]: N-Acetyl cysteine (NAC) 300 mg, Acetyl L-carnitine 250 mg, Magnesium 92.5 mg, Alpha lipoic Acid 100 mg, Selenium 13.8 µg, Beta carotene + Vitamin A 5666 IU, Zinc 2.4 mg, Vitamin C 21 mg, Copper 0.225 mg, Vitamin B1 0.3 mg, Boron 0.5 mg, Vitamin B2 0.3 mg, Potassium 1200 mg, Pantothenic acid 1.3 mg, Iron 3.3 mg, Niacinamide 3.8 mg, Manganese 0.5 mg, Inositol 15 mg, Biotin 7.5 µg, Vitamin B6 0.3 mg, Chromium 7.5 µg, Vitamin B12 0.6 µg, Molybdenum 11.3 µg, Vitamin D 52 IU, Choline 121.9 mg, Vitamin E 5.7 IU, Bioflavonoid complex 75 mg, Folic acid 100 µg, L-Glutamine 25 mg, Betaine HCL 37.5 mg;
2. A multi-component formula containing zinc 30mg, vitamins A + beta carotene 5666 IU , C 21mg and E 5.7 IU, selenium 13.8µg, iron 3.3mg, folic acid 100µg, vitamin B12 0.6 µg, vitamin B6 0.3 mg, vitamin B1 0.3mg
3. A basic supplement containing zinc 30mg, vitamins A 666 IU, vitamin C 21mg and E 5.7 IU, and folic acid 100µg and 16 mg docosahexaenoic acid (DHA-Omega 3 Fatty Acid) and 24mg eicosapentaenoic acid (EPA-Omega 3 Fatty Acid) \[Austin, J. et.al 2006 \& Alan DD, et.al 2006\].

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms	NCT03177681	Malignant Neopl...	Tongue Assessme... Stool Sample Questionnaires Holter Monitor Yogurt	18 Years -	M.D. Anderson Cancer Center
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies	NCT00517803	HIV Infections Cancer, Second ...	Probiotic Yogur... Probiotic Yogur... Probiotic yogur... Probiotic Yogur...	18 Years - 85 Years	Lawson Health Research Institute
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies	NCT00517803	HIV Infections Cancer, Second ...	Probiotic Yogur... Probiotic Yogur... Probiotic yogur... Probiotic Yogur...	18 Years - 85 Years	Lawson Health Research Institute
The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms	NCT03177681	Malignant Neopl...	Tongue Assessme... Stool Sample Questionnaires Holter Monitor Yogurt	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for yogurt

Every month we try and update this database with for yogurt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for yogurt

Every month we try and update this database with for yogurt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for yogurt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.