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Clinical Trial of the GFCF diet in children with GI disorders

Posted May 19 2010 3:22pm

The gluten free, casein free diet is not beneficial to all autistics. Not even most. But the question remains, how about a small subset? What about autistics with gastrointestinal (GI) conditions?

I find the phrasing “Autism Associated Gastrointestinal Disorders” a bit odd. Are they trying to say that the GI disorders are linked to the autism? Since there is no group as yet shown to have GI disorders linked to autism, this would seem a tricky criteria to implement. How will they, for example, chose those who have GI disorders “associated” with autism vs. those who have autism and GI disorders which are not associated?

Ah well, best not to get tied up in those details.

Here are the inclusion criteria:

Inclusion Criteria:

  • Informed consent / Assent, as applicable must be signed prior to executing any study related procedure
  • Children, male or female, 2 to 17 years old (inclusive)

Confirmed diagnosis of ASD according to the diagnostic measures o DSM-IV Symptom Checklist
o Autism Diagnostic Observation Schedule(ADOS)&/or Autism Diagnostic Interview Revised(ADI-R)within 18 months prior to entry into the study

  • Able to consume at least 2 cartons of the study drink daily

Subjects must present with a current history of at least two of the following persistent GI symptoms as confirmed by the study physician o Diarrhea, as characterised by three or more loose stools a day for at least 8 out of 14 days
o Constipation as characterised by less than 3 bowel movements per week, for at least a 2-week period
o Esophageal reflux, as characterised by 3 or more episodes of regurgitation per day on 10 out of 14 days
o Abdominal pain manifested as pain after eating or self injurious behavior on at least 8 out of 14 days
o Suspected food allergy which is confirmed by a physician, as characterized as a recurrent reaction or association with specific foods

I think that last one is keysuspected food allergy with recurrent reactions to specific foods. Of course such conditions should be treated, and would likely respond to changes in diet.

I also question “Abdominal pain manifested as pain after eating or self injurious behavior on at least 8 out of 14 days”. How is self-injurious behavior a manifistation of abdominal pain? Yes, I can see how a child with abdominal pain could be self injurious, but I can also see that many children with self injurious behaviors could have them as a result of other conditions.

Here are the exclusion criteria:

Exclusion Criteria:

  • Children with a history of anaphylaxis to dietary milk and wheat proteins
  • Children with severe concurrent illness
  • Children who are prescribed systemic steroids
  • Children currently receiving chelation therapy, hyperbaric or antifungal treatment within 1 month of entry into the study and during the study period.
  • Children with a confirmed diagnosis of celiac disease
  • Subjects who have previously tried dietary elimination of casein and gluten for at least 1 month period and failed to demonstrate a response by parent perception
  • Children who are unable to consume at least 2 cartons of the study drink daily

It strikes me a bit odd that children who have been on “The Diet” in the past but didn’t respond would be excluded while those whose parents who tried “The Diet” and perceive benefit would be included. But, I guess this is a treatment study, not a “demonstrate that GI complaints exist in autistic children” so that selection bias may be OK. It will be interesting to see to what level parents’ perceptions are accurate in these cases.

The real question I have is, why? Why do this study? Why focus on autistics? If a person, child or adult, autistic or not, has a food allergy and reacts to those foods, of course take them out of the diet.

But, not all of the children in this study will have suspected food allergies. Any two of the criteria above are required for inclusion in the study. But, I’m still stuck with “why autistics”. Why not study children, any children, who have GI complaints and see if they respond to the GFCF diet? Or, why not study both autistics and non-autistics and shed some light on the assertion that GI disorders are associated with autism?

The study is being conducted at Massachusetts General Hospital with Dr. Tim Buie as the investigator. Anyone interested in participating can find the contact information on the Clinical Trials announcement .

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