This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA [2.5 mg] and ferrous fumarate [2.5 mg]) and galacto-oligosaccharides (GOS), 7.5 mg.

This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA [2.5 mg] and ferrous fumarate [2.5 mg]), bovine lactoferrin (bLF), 1.0 g.

This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA [2.5 mg] and ferrous fumarate [2.5 mg]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.

This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA [2.5 mg] and ferrous fumarate [2.5 mg]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).

Iron-deficiency

Galacto-oligosaccharides are classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, are components of cow's milk and have been used repeatedly in clinical trials without adverse effects.

Galacto-oligosaccharides

Bovine lactoferrin is classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, is a component of cow's milk and has been used repeatedly in clinical trials without adverse effects.

Bovine lactoferrin

The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg [(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg].

Multiple micronutrient powders with 5 mg iron

Jomo Kenyatta University of Agriculture and Technology

Swiss Federal Institute of Technology (ETH Zürich)

Prebiotic GOS and Lactoferrin With Iron Supplements

Prebiotic GOS and Lactoferrin for Beneficial Gut Microbiota With Iron Supplements

The primary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) to beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera in fecal microbiota as determined by quantitative polymerase chain reaction (qPCR) at 1 month.

A key secondary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) to beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera in fecal microbiota as determined by quantitative polymerase chain reaction (qPCR) at 6 months.

A key secondary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) to beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera in fecal microbiota as determined by quantitative polymerase chain reaction (qPCR) at 9 months.

A secondary outcome measure will be the microbiota composition among study groups as determined by quantitative polymerase chain reaction (qPCR) measures of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) and of beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera at 1, 6, and 9 months.

A secondary outcome measure will be the prevalence of diarrhea among study groups

A secondary outcome measure will be the prevalence of malaria among study groups

A secondary outcome measure will be the prevalence of anemia among study groups

A secondary outcome measure will be the prevalence of iron deficiency among study groups

A secondary outcome measure will be the prevalence of iron deficiency anemia among study groups

A secondary outcome measure will be the prevalence of inflammation among study groups

A secondary outcome measure will be the prevalence of other illnesses among study groups

Gary M Brittenham, MD

Professor of Pediatrics and Medicine

Columbia University

Swiss Federal Institute of Technology

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The study is a single-center, double-blinded, randomized, 9-month clinical trial with a 2X2 factorial design to determine the efficacy of galacto-oligosaccharides and bovine lactoferrin in preserving a beneficial gut microbiota during iron supplementation in Kenyan infants.

Stratified randomization will be carried out by the Trial Statistician using computer-generated randomly permuted blocks of size 2, 4 or 6 with stratification by gender and assignment of eligible infants to one of the 4 intervention groups using 4 color codes. Allocation will be known solely by the Trial Statistician and the Clinical Trial Safety Officer and concealed from all other study personnel.

VSL#3 is a mix of lactic acid bacteria and bifidobacteria (original De Simone's formulation)

HIV Seropositivity

VSL#3 sachets

Policlinico Umberto I Hospital

Effects of VSL#3 on Neuro-cognitive Profile of HIV Patients

Title Effect of Microbial Translocation and Supplementation With the Probiotic VSL#3 on Neuro-cognitive Functions of HIV Positive Patients Receiving HAART

HIV dementia-scale, Beck Depression Inventory BDI-II, State Trait Anxiety Inventory (STAI Y 1 - Y2), the questionnaire for the assessment of quality of life in persons with HIV infection (ISS-QoL)

Dott.ssa Gabriella D'Ettorre

Azienda Policlinico Umberto I

L-ornithine L-aspartate (6 ampules, each ampule containing 5 grams of the drug in 10 ml solution) to be diluted in 440 ml of Dextrose 5% (to make a total of 500 ml of solution), as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Placebo (sterile water, 6 ampuoles of 10 ml each) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Cirrhosis of Liver

Hepatic Encephalopathy

L-ornithine L-aspartate

Placebo (sterile water, 60 ml) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Placebo

Department of Gastroenterology, D.M.C. and Hospital

G.B. Pant Hospital

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

Efficacy of Intravenous 'L-ornithine L-aspartate' in Reversal of Overt Acute Hepatic Encephalopathy in Patients With Liver Cirrhosis: a Prospective, Randomized, Double-blind, Placebo Controlled Trial

Mental state grade according to West Haven criteria for Hepatic encephalopathy

Change in blood ammonia levels will be measured at baseline and after 5 days of treatment

Mortality rate in the two groups at 4 weeks will be compared

The total length of hospital stay (number of days) in each group will be compared.

Change in serum cytokine levels (Interleukin-1, Interleukin-6, Interleukin-10 and TNF-alpha will be measured at baseline and after 5 days of treatment.

organic acid/dijareja

Prebiotic GOS and Lactoferrin With Iron Supplements

Effects of VSL#3 on Neuro-cognitive Profile of HIV Patients

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

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