The effectivness of camel milk in autism spectrum disorders

ISRCTN	ISRCTN87863054
DOI	https://doi.org/10.1186/ISRCTN87863054
Secondary identifying numbers	2011-2

Submission date: 07/10/2010
Registration date: 12/04/2011
Last edited: 18/04/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Laila AL-Ayadhi
Scientific

Autism Research and Treatment Centre
Sheikh Al-Amoudi Autism Research Chair
Department of Physiology (29)
Faculty of Medicine
King Saud University
PO Box 2925
Riyadh
11461
Saudi Arabia

Phone	+966 (0)1 469 9349
Email	ayadh2@gmail.com

Study information

Study design	Longitudinal interventional single-blinded single centre trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please contact Professor Al-Ayadhi [ayadh2@gmail.com] to request a patient information sheet
Scientific title	The therapeutic possibilities of camel milk in autism spectrum disorders: a longitudinal interventional single-blinded single centre trial
Study objectives	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.)
Ethics approval(s)	Institutional Review Board approved on 23rd March 2011 (ref: 11/2967/IRB)
Health condition(s) or problem(s) studied	Autism spectrum disorders
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Camel milk
Primary outcome measure	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)
Secondary outcome measures	1. Improve general health 2. Improve social relation 3. Improve academic performance Outcomes measures immediately following intervention, and 3 and 6 months afterwards.
Overall study start date	10/01/2011
Completion date	10/01/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	15 Years
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	10/01/2011
Date of final enrolment	10/01/2013

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

Autism Research and Treatment Centre

Riyadh
11461
Saudi Arabia

Sponsor information

King Abdul Aziz City for Science and Technology (KACST) (Saudi Arabia)
Research organisation

Autism Research and Treatment Centre
Sheikh Al-Amoudi Autism Research Chair
Department of Physiology (29)
Faculty of Medicine
King Saud University
PO Box 2925
Riyadh
11461
Saudi Arabia

Website	http://twahud.com
"ROR"	https://ror.org/05tdz6m39

Funders

Funder type

Research organisation

King Abdul Aziz City for Science and Technology (KACST) (Saudi Arabia) - Autism Research and Treatment Centre (ART Centre)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan