Synbiotic Approach to Immunity and Metabolism in the Elderly Study
Maneno muhimu
Kikemikali
Maelezo
The aim of this study is to investigate the effect of probiotic Lactobacillus rhamnosus GG (commercialised as LGG), a pilus-less derivative L. rhamnosus GG (LGG-PB12)combined with a putative prebiotic PromitorTM (soluble corn fiber) i.e. a synbiotics and PromitorTM (SCF alone) on the faecal microbiota composition, metabolism and immunity in healthy individuals aged 60-80 years.
It consists of a 3 week randomised intervention treatment periods with the synbiotics, prebiotic and placebo control. Any adverse medical events which occur during the trial (e.g. headache, gut symptoms) should be recorded in a diary along with medication taken.
Tarehe
Imethibitishwa Mwisho: | 04/30/2017 |
Iliyowasilishwa Kwanza: | 05/10/2017 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 05/22/2017 |
Iliyotumwa Kwanza: | 05/29/2017 |
Sasisho la Mwisho Liliwasilishwa: | 05/22/2017 |
Sasisho la Mwisho Lilichapishwa: | 05/29/2017 |
Tarehe halisi ya kuanza kwa masomo: | 11/30/2013 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 09/30/2014 |
Tarehe ya Kukamilisha Utafiti: | 12/31/2014 |
Hali au ugonjwa
Uingiliaji / matibabu
Dietary Supplement: LGG+Promitor™
Dietary Supplement: Promitor™
Dietary Supplement: LGG-PB12+Promitor™
Dietary Supplement: Maltodextrin
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
Experimental: LGG+Promitor™ LGG:10^12 CFU/g Lactobacillus rhamnosus GG (commercialised as LGG) combined with Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. | Dietary Supplement: LGG+Promitor™ synbiotic |
Experimental: Promitor™ Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. | Dietary Supplement: Promitor™ Soluble Corn Fiber |
Experimental: LGG-PB12+Promitor™ LGG-PB12:10^12 CFU/g of a pilus-less derivative L. rhamnosus GG combined with Promitor™:12g fibres/delivered of Soluble Corn Fibre (SCF) as dry powders to be consumed as 250 ml beverages at breakfast. | Dietary Supplement: LGG-PB12+Promitor™ synbiotic |
Placebo Comparator: Maltodextrin Maltodextrin (an oligosaccharide without prebiotic effect) 12g delivered and served as dry powders to be consumed as 250 ml beverages at breakfast. | Dietary Supplement: Maltodextrin Control |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 60 Years Kwa 60 Years |
Jinsia Inastahiki Kujifunza | All |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | Inclusion criteria: - aged between 60 and 80 years of age. - in good general health, defined as no comorbidities requiring regular medical follow up - Ability to communicate well with the investigator and to comply with the requirements of the entire study Exclusion criteria: - History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years - Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks and during the trial period - Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study - Undergone surgical resection of any part of the bowel - History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma). - Currently prescribed immunosuppressive drugs - Intention to use regularly other medication which affects gastrointestinal motility and/or perception - Current or recent history (within 12 months) of significant drug or alcohol abuse or dependence |
Matokeo
Hatua za Matokeo ya Msingi
1. The modulation of the gut microbiota by synbiotics and PromitorTM inflammatory/immune biomarkers [Changes from baseline to 21 days synbiotics and PromitorTM treatment]
Hatua za Matokeo ya Sekondari
1. The modulation of immune function by synbiotics and PromitorTM [Changes from baseline to 21 days synbiotics and PromitorTM treatment]
Hatua Nyingine za Matokeo
1. Digestive symptoms [Changes from baseline to 21 days synbiotics and PromitorTM treatment]
2. Microbiota activity (intestinal gas production) [Changes from baseline to 21 days synbiotics and PromitorTM treatment]