Trial record 12 of 22 for:    " August 01, 2007":" August 31, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Lawson Health Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00517803
First received: August 16, 2007
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

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].


Condition Intervention
HIV Infections
Cancer, Second Primary
Dietary Supplement: Probiotic Yogurt B: with various micronutrients
Dietary Supplement: Probiotic Yogurt A: Kaiser micronutrients
Dietary Supplement: Probiotic yogurt C: with basic micronutrients
Dietary Supplement: Probiotic Yogurt D: Placebo -- no added micronutrients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies: A Randomized, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Statistically significant improvement of immune status (CD4) Statistically significant improvement of nutritional status [ Time Frame: Baseline and Follow-up for each yogurt type ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improved quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Probiotic Yogurt B: with various micronutrients
175g probiotic yogurt / day 25% RDA for each nutrient
Dietary Supplement: Probiotic Yogurt A: Kaiser micronutrients
175g probiotic yogurt/ day 25% RDA for each nutrient
Dietary Supplement: Probiotic yogurt C: with basic micronutrients
175g yogurt/ day 25% RDA for each nutrient
Placebo Comparator: 2 Dietary Supplement: Probiotic Yogurt D: Placebo -- no added micronutrients
175g/day probiotic yogurt

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinically tested CD4 lymphocyte count between 200-400cells/mL (HIV population)
  • Confirmed cancer by physician (cancer population)
  • Confirmed HIV by physician (HIV population)

Exclusion Criteria:

  • Opportunistic infection
  • Mental illness impairing ability to comply with study
  • Pregnancy
  • Currently consuming micronutrient supplement or probiotic
  • Clinical history of lactose-intolerance or cow's milk allergies
  • Require surgery, radiation or chemotherapy during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517803

Locations
Canada, Ontario
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Gregor Reid, PhD Lawson Health Research Institute
  More Information

Additional Information:
Publications:
Cunningham-Rundles, S.,Ahrne, S. Bengmark, S. Johann-Liang, R. Marshall, F., Metakis,L, Califano, C.,Dunn, A., Grassey, C. Hinds, G. & Cervia, J. 2000 Probiotics and Immune Response, American Journal of Gastroenterology. 1 (95) 22-25

Responsible Party: Dr. Gregor Reid, University of Western Ontario
ClinicalTrials.gov Identifier: NCT00517803     History of Changes
Other Study ID Numbers: R-07-220, 13468
Study First Received: August 16, 2007
Last Updated: July 6, 2009
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
micronutrients
immunodeficiency
probiotics
yogurt
Healthy
Acquired Immunodeficiency Syndrome
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Neoplasms, Second Primary
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Neoplasms
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014