A controlled clinical trial to determine the potential of a prebiotic to beneficially influence the gut bacteria and immune defences of hospitalised elderly patients
- Conditions
- Gut microflora composition and immune functionDigestive SystemGut microflora composition
- Registration Number
- ISRCTN26496022
- Lead Sponsor
- Clasado Ltd (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method