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The effectivness of camel milk in autism spectrum disorders
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| ISRCTN |
ISRCTN87863054
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| ClinicalTrials.gov identifier |
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| Public title |
The effectivness of camel milk in autism spectrum disorders
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| Scientific title |
The therapeutic possibilities of camel milk in autism spectrum disorders: a longitudinal interventional single-blinded single centre trial
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| Acronym |
N/A
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| Serial number at source |
2011-2
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| Study hypothesis |
1. To investigate the benefits and effect of camel milk as an interventional strategy in autistic children
2. To determine the efficiency of camel milk as an intervention method in reducing food allergy symptoms seen in autistic children (diarrhoea, vomiting, skin rashes, etc.)
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| Lay summary |
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Ethics approval
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Institutional Review Board approved on 23rd March 2011 (ref: 11/2967/IRB)
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| Study design |
Longitudinal interventional single-blinded single centre trial
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| Countries of recruitment |
Saudi Arabia |
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| Disease/condition/study domain |
Autism spectrum disorders
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| Participants - inclusion criteria |
1. Children with autism spectrum disorders (ASD) confirmed by Autism Diagnostic Observation Schedule (ADOS) and Developmental, Dimensional and Diagnostic Interview (3DI)
2. Aged between 4 and 15 years, either sex
3. All simplex cases
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| Participants - exclusion criteria |
1. Fragile X gene study
2. Tuberous sclerosis
3. Angleman syndrome
4. Other serious neurological conditions (e.g., seizures)
5. Psychiatric (e.g., bipolar disorder) or known medical conditions
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| Anticipated start date |
10/01/2011
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| Anticipated end date |
10/01/2013
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| Status of trial |
Completed |
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| Patient information material |
Not available in web format, please contact Professor Al-Ayadhi [ayadh2@gmail.com] to request a patient information sheet
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| Target number of participants |
60
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| Interventions |
This project will be conducted on autistic children (60) with typical behavioural disorders (divided into 2 groups, group 1 will receive cold pasteurised camel milk, group 2 will receive boiled camel milk).
The children will be assessed by a psychologist and a physician who are expert in autism diagnosis. Written informed consent will be obtained from the parents of the children. We will study autistic children with typical behaviour who did not benefit from conventional treatment. A blood sample will be taken (EDTA and plain tubes).
Camel milk will be obtained by the Autism Research and Treatment Centre from a source that will be hygienic and the milk will be tested for bacterial and viral contamination before dispensing to the children. The parents will be instructed not to heat the milk, which would destroy the immunoglobulins and protective proteins therein.
The parents will report daily on the progress of their children. Milk will be supplied frozen and thawed as needed (without adverse effects on the milk, which returns to its initial solution). The milk will replace all other foods for 2 weeks, after which other food can be gradually added to the diet as chosen by the parents.
Resulting information will be used as a tool for the treatment of autism spectrum disorder which would be validated by large-scale clinical trials.
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| Primary outcome measure(s) |
1. Less allergy
2. Increased attention
3. Increased concentration
Outcomes assessed at baseline, 3 and 6 months, using the following tools:
1. Parent Questionnaire
2. Social Responsiveness Scale (SRS)
3. Childhood Autism Rating Scale (CARS)
4. Autism Treatment Evaluation Checklist (ATEC)
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| Secondary outcome measure(s) |
1. Improve general health
2. Improve social relation
3. Improve academic performance
Outcomes measures immediately following intervention, and 3 and 6 months afterwards.
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| Sources of funding |
King Abdul Aziz City for Science and Technology (KACST) (Saudi Arabia) - Autism Research and Treatment Centre (ART Centre)
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| Trial website |
http://www.twahud.com
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| Publications |
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| Contact name |
Prof
Laila
AL-Ayadhi
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| Address |
Autism Research and Treatment Centre
Sheikh Al-Amoudi Autism Research Chair
Department of Physiology (29)
Faculty of Medicine
King Saud University
PO Box 2925
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| City/town |
Riyadh
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| Zip/Postcode |
11461
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| Country |
Saudi Arabia
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| Tel |
+966 (0)1 469 9349
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| Fax |
+966 (0)1 467 2567
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| Email |
ayadh2@gmail.com
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| Sponsor |
King Abdul Aziz City for Science and Technology (KACST) (Saudi Arabia)
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| Address |
Autism Research and Treatment Centre
Sheikh Al-Amoudi Autism Research Chair
Department of Physiology (29)
Faculty of Medicine
King Saud University
PO Box 2925
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| City/town |
Riyadh
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| Zip/Postcode |
11461
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| Country |
Saudi Arabia
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| Sponsor website |
http://twahud.com
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| Date applied |
07/10/2010
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| Last edited |
18/04/2011
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| Date ISRCTN assigned |
12/04/2011
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