To ask Her Majesty’s Government what consideration they will give to using prebiotics to prevent Clostridium difficile in a clinical setting, with a view to improving patient experience and saving NHS resources.
There is currently insufficient evidence to show that prebiotics offer benefits in a clinical setting to be able to make a general recommendation in relation to prevention of Clostridium difficile infection. Of course, we will keep this issue under review. However, it is important for all patients, including those who have contracted Clostridium difficile infection, to have a well-balanced diet.
My Lords, I thank the noble Earl for that answer. Is he aware that C. difficile costs the country about £100 million a year and prebiotics are very cheap? Prebiotics are a food supplement that bypasses the stomach and goes into the gut and helps to keep a person fit, so that they may not get C. difficile. Does he agree that anything is worth trying with such a debilitating and dangerous condition?
The noble Baroness is absolutely right, not for the first time, about the devastating incidence of C. difficile infection. More than 25,000 cases of C. difficile infection are reported annually and there remain significant variations in outcomes among organisations.
In principle, prebiotics should be beneficial, but there is in fact little good evidence to show that they work or that food can provide a prebiotic effect. There is likely to be considerable inter-patient variation in the gut flora response to prebiotics, which could be exacerbated by differences in diet. However, as I have already indicated, we will look closely at the issue.
My Lords, given the difficulties and dangers of Clostridium difficile, can my noble friend reassure me that the Department of Health has noted that the Food and Drug Administration has in recent days approved fast-track designation for a parenteral toxoid vaccine, which thus opens the possibility—I hope—that immunisation will be possible, in particular for elderly, vulnerable people who are in danger of developing Clostridium difficile infection?
My Lords, I am aware of the interesting development of a vaccine for C. difficile, but I understand that the vaccine is still in clinical trials. As my noble friend indicated, the company may be seeking agreement from the US FDA to fast-track the application when the development programme is complete, as that would give them access to the US market. It is of course for the manufacturer to decide when and if it wishes to seek access to the market in the UK and the wider EU.
My Lords, as I have said, we will continue to look at the matter with interest. Of course the department has a very sizeable clinical research budget, which is open to all bids of a high quality. There is no reason why a bid should not be made on this issue as well.
My Lords, I will try again. Can the Minister tell me whether carbolic—either as a soap or as a cleaner—has any effect on C. difficile, or is C. difficile resistant to carbolic?
My Lords, my advice is that best practice guidance on the diagnosis and treatment of Clostridium difficile infection is clear and is available. The management of the infection requires the isolation of cases, hand-washing with soap and water and the use of the antibiotics metronidazole or vancomycin.
My Lords, the Minister said that there was not enough evidence to be sure that prebiotics are effective. Can he say whether any active efforts will be made to get that evidence, or does he mean that people must wait until a request has been made before such efforts are embarked upon?
My Lords, we regard the departmental budget as being there to enable those who have good-quality and well-designed research projects to bid for those funds. I will take on board my noble friend’s implicit suggestion that the department should pursue the issue but, in doing so, I bear in mind that these products are commercially produced and that it is really for the manufacturers to come up with robust clinical data.
My Lords, is the noble Earl aware that there are more trials on probiotics than on the prebiotics mentioned by the noble Baroness, Lady Masham? Although there are no Department of Health trials that I am aware of, was the Minister suggesting in his earlier response that he is seeking the opportunity for such trials to take place?
My Lords, I merely meant to indicate that we would welcome good-quality proposals. On probiotics, I understand that one study using live yoghurt showed a patient benefit but my advice is that the study methodology was flawed and its findings were not generalisable. Probiotics are not therefore recommended, as studies have failed to show any convincing evidence that they either treat or prevent C. difficile infection.
My Lords, is the noble Earl concerned about the presence of the potentially more aggressive and resistant forms of C. difficile that have been identified in our hospitals? What action is being taken to ensure that they do not spread more widely?
My Lords, the noble Lord is absolutely right. It is appropriate for me to emphasise that, as he will well know, inappropriate prescribing of antibiotics is above all what has caused the high levels of infection that we have seen in recent years. The use of broad-spectrum antibiotics predisposes people to C. difficile infection, so it is important that those in the health service understand the cause and effect relationship involved.
It is also worth mentioning that tomorrow is European Antibiotic Awareness Day, so it is appropriate that this Question has been asked today.
My Lords, I know what an antibiotic is, but can the Minister help me with what a prebiotic is and what a probiotic is?
My noble friend has asked the question, and I hope that he will be pleased with the answer. Prebiotics are non-digestible carbohydrates that act by promoting the growth and/or activity of probiotic bacteria in the gut. The most common prebiotics are fructo-oligosaccharides, inulin and galacto-oligosaccharides. They are found in various vegetables and fruit, such as tomatoes, asparagus and bananas. The best example of a probiotic is yoghurt.