EAT Allergy prevention trials- would you take part with your new born?

[CrazyPregnant]

Hi all, I have posted this in WWYD but no replies so thought I would try here....

While at the hospital for 12 week scan yesterday I was approached by someone to ask if I would be interested in taking part in a new study being done by Guy's and St Thomas' hospital (with support from the FSA) to look at how best to prevent allergies in young children.

The study would be split into two groups- first group following current government guidelines of exclusive breastfeeding until 6 months with no early introduction of allergenic food.

Group 2 would exclusively breastfeed until 3 months, then introduce baby rice, then yoghurts containing cows milk (2 a week) them in a randomized order- 1 egg per week, wheat, fish, peanut butter, and sesame. The aim being that al food being ingested at required quantities by 5 months. No wheat will be introduced before 4 months.

I am split- I know how important it is that people participate in research so that progress can be made but I am concerned about my baby being used as a guinea pig! I know that sounds selfish- I would usually exclusively bf until 6 months then use a mixture of BLW and purees to wean after that- I'm not sure I want to HAVE to wean my child at 3 months. The thing is I understand that allergies affect some peoples lives very badly and I am in a position to maybe help change things..... so wwyd?

That trial can't be blinded and therefore doesn't strike me as terribly useful.

Pardon my ignorance but what does "blinded" mean?

hmm, not sure. Do thy test for allergies at the outset?

Yes they give a skin prick test to ensure no allergies have already developed.

In a nutshell, 'blinding' is a tool to avoid a study just confirming the researcher's prejudice by not letting him know which group is which in the trial.

The gold standard in research is the "double-blind" trial, in which neither the scientists conducting the trial, nor the people who participate know who is in which group, so neither group can influence (conciously or subconciously) the result.

Ben Goldacre is better at explaining it than I am, and there's a really good long and concise explanation how and why it works and why it is needed in his book, too

www.badscience.net/index.php?s=double-blind

Good god no way would I submit to having to feed my baby proteins from 3 months, given the gut and food intolerance problems we have in our family. Group 2 would be self-selecting in all likelihood since nobody like me would willingly subject their child to such a regime.

That study seems flawed from the outset, because people who would have weaned early anyway probably come from families where it's always been the norm and no-one has suffered any ill-effects, so arguably less likely to end up with allergy problems anyway.

WidowWadman- would the fact the trial is not blinded make that much of a difference in this case, as a positive or negative result to the allergy testing is final- it can not be altered to suit someones preference?

I'm not sure where the prejudice lies in this trial- the blurb says the aim of the study is to find out how best to prevent food allergies. It goes onto say that peanuts etc are common place in childrens diets from a young age in places like Africa & Asia where allergies are diagnosed less often.

Duchesse, I said to the lady I wasn't keen on the idea of early weaning but you can't choose which group yo are in so would have to take what I was given... I am leaning more towards not participating now!

I wouldn't take part in such a trial

Do they never think that perhaps the people in Africa & Asia have already genetically selected those who tended to allergy ie they died out

I am actually doubting that this study would even be permitted by an ethics committee. Assuming that they are studying the effect of early weaning on subsequent allergies and intolerances, this study potentially puts a large of very small children at risk of lifelong problems. I would be beyond surprised if it were approved.

No I wouldn't. You can't really double blind a trial like this and soemthing similar could still be useful. But why 3 months not 4 or 5 and why all the foods and not just one of them per child? They are already doing the LEAP study www.leapstudy.co.uk/ and I'd want to know how that was progressing before considering anything further.

tatt, it is the same study group conducting the LEAP study from the blurb I have been given-

"The Learning Early About Peanut Allergy (LEAP) Study
Our study group is already undertaking a randomized trial introducing peanut into the diet of infants aged between 4 and 10 months of ages who are a high risk of developing food allergies to see whether this decreases the chances of developing peanut allergy. Nearly 620 infants are taking part and half are successfully consuming a peanut snack."

Duchesse- From the consent forms & information I have been given I get the impression it has been approved, I could be wrong there though.
"Who is organising and funding the research?
The study is being run by Prof Gideon Lack and his team of researchers. The Food Standards Agency, a Government department, the Medical Research Council and the Department of Health's National Institute of Health Research (NIHR) are funding the study.

Who has reviewed the study?
St Thomas' Hospital Research Ethics Committee, the Food Standards Agency. the Medical Research Council and the NIHR have reviewed the study."

CrazyPregnant I know it's the same group. The study page says "We anticipate that the study will reach completion in 2013, at which time the results will be analysed and published. " Until they have completed the study and analysed the results it is premature to say that "half are successfully consuming a peanut snack". Enrollment of the study began in December 2006 so they may have some sort of interim analysis but I would want to see the figures before getting into any study involving both more foods and even earlier introduction of allergenic foods.

I'd want to know things like how many children have developed nut allergy in both groups and how many children were withdrawn from the group consuming nut. Also if there were any differences between the two groups in terms of things like family history of allergies.

Presumably some people will sign up before birth then have a child who screams at dairy in their mothers breast milk and they'll drop out. They are going to have to analyses drop-out rates very carefully in any of their studies.

Thanks for your reply tatt, very useful to see other peoples point of view.

I agree with Tatt (sorry to be unoriginal).

Hi,
I come from a family ridlled with allergies and am taking part in this study with my son.
I figured that the current way of doing things isn't proving too successful at reducing/ preventing allergies so may aswell give it a go!
Of course, I wasn't blaze about entering into this. I spent days and days researching, talking to the research team, our GP and a couple of neutral paediatricians that I am lucky enough to know. Turns out my son is severly alergic to eggs...I truly believe that we are getting better care and advice than we could have hoped for with local services.

No, I wouldn't, cause of our family history of allergies . Course, it is exactly people like me (or rather my children) who would be most useful for such trials but I just couldn't do it. Hats off to anyone who does have the courage tho.

Having said that, if ds2 turned out to be allergic to nuts (after absolute avoidance since conception due to ds1's allergies) and there was a ds3 I might do it cause then I'd feel I was out of options iyswim?