Is B12 deficiency caused by an abnormal colonic bacterial flora?
Research type
Research Study
Full title
DO PATIENTS WITH INCREASED B12 REQUIREMENTS HAVE AN ABNORMAL COLONIC MICROFLORA?
IRAS ID
151130
Contact name
John Hunter
Contact email
Sponsor organisation
Martyn Hooper, The Pernicious Anaemia Society
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Study Summary
This study is designed to investigate the reason that many patients with B12 deficiency suffer from chronic fatigue and require more frequent B12 supplementation than the standard 3 monthly injections.
24 Members of the Pernicious Anaemia society with a diagnosis of B12 deficiency will be invited to take part. 12 will suffer chronic fatigue if B12 injections are more than a month apart and 12 will be perfectly well on the 3 monthly standard regime.
A sample of faeces will be sent to a laboratory in Wales to find out which bacteria are present and a sample of urine to the Open University to see which chemicals these bacteria are producing and whether any are toxic. A dried sample of faeces will be sent for analysis at the University of Kent to determine how much of the vitamin is present in the faecal bacteria. The results in the two groups will be compared to see whether the gut bacteria are different.
Patients will be asked to provide samples at home and post to laboratories in SAEs. They will be asked to complete a questionnaire outlining their symptoms and to complete a consent form. It will not be necessary for them to attend for any medical examinations.
This study is being directed and co-ordinated by Professor John Hunter at Addenbrookes hospital Cambridge, who will analyse the results, but he will be blind to the personal details of the participants. All samples will be sent directly to the laboratories involved and not to Addenbrookes Hospital.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/0220
Date of REC Opinion
31 Mar 2015
REC opinion
Further Information Favourable Opinion