CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Probiotic Yogurt B: with various micronutrients +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00517803
NCT00517803N/ACompleted

Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies: A Randomized, Placebo-controlled Trial

In Brief

A clinical study evaluating Probiotic Yogurt B: with various micronutrients, Probiotic Yogurt A: Kaiser micronutrients, and 2 other interventions for HIV Infections and Cancer, Second Primary. Completed, enrolled 24 participants across 1 site.

Detailed Summary

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 \[Kaiser, et.al 2006\].

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 17, 2007
Enrollment StartSep 7, 2007
Primary CompletionMar 2, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.9 years ago

Interventions

Probiotic Yogurt B: with various micronutrientsdietary

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

Probiotic Yogurt A: Kaiser micronutrientsdietary

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

Probiotic yogurt C: with basic micronutrientsdietary

175g yogurt/ day 25% RDA for each nutrient

Probiotic Yogurt D: Placebo -- no added micronutrientsdietary

175g/day probiotic yogurt