Gut microflora composition and immune function Digestive System Gut microflora composition
Conditions
Interventions
Patients are randomised to one of two groups (prebiotic/placebo). Patient will be supplemented with the treatment (dosage 5.5 g per day in powder format that can be dissolved in water or juice) for th
Sponsors
Clasado Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Inpatients aged 65 or older, either sex 2. Ability to communicate well with the investigator and to comply with the requirements of the entire study 3. Patient has given written informed consent to participate and is willing to participate in the entire study 4. Patient is admitted to the hospital for a minimum of one week
Exclusion criteria
Exclusion criteria: 1. Patients lacking capacity who are therefore unable to consent 2. Diarrhoea on admission, within the preceding week or reported recurrent diarrhoea 3. Severe allergy or any history of severe abnormal drug reaction, drug or alcohol abuse 4. Intake of more than two courses of antibiotics in the previous four weeks 5. Former participation in another study involving prebiotic or probiotic supplements or investigational drugs within the previous 1 month, or intention to use such drugs during the course of the study 6. Undergone surgical resection of any part of the bowel 7. Currently prescribed immunosuppressive drugs including oral steroids 8. Patients with any heart valve replacement or history of rheumatic heart disease or infective endocarditis 9. Severe life threatening illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of B-GOS on the faecal microflora of hospitalised elderly individuals, using the combination of 5'CY3-labelled 16S-ribosomal RNA oligonucleotide probes and epifluorescent microscopy known as Fluorescent In Situ Hybridisation (FISH). The main groups to be enumerated by this method will be: bifidobacteria, lactobacilli, clostridia, eubacteria, bacteroides and E. coli. Assessed at the beginning and end of hospitalisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To investigate the effect of B-GOS on immunity, as a result of the improvement of the microflora composition, using routine immunological tests as well as cytokine analyses and phagocytosis, analysed in blood samples at the beginning and end of hospitalisation 2. To conduct a daily assessment of stool frequency, stool consistency, bloating, flatulence and abdominal pain, assessed daily based on the hospital records (nurse and doctor visits) 3. To assess the effect of B-GOS on the duration of hospital stay in elderly patients, assessed daily based on the hospital records (nurse and doctor visits) 4. To assess the effect of B-GOS on the incidence and duration of gastrointestinal infections manifest thorough diarrhoea, assessed daily based on the hospital records (nurse and doctor visits) 5. To assess the tolerability and confirm the safety of B-GOS in elderly hospitalised patients, assessed daily based on the hospital records (nurse and doctor visits) | — |
Countries
United Kingdom
Outcome results
None listed