Condition category
Mental and Behavioural Disorders
Date applied
07/10/2010
Date assigned
12/04/2011
Last edited
18/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.twahud.com

Contact information

Type

Scientific

Primary contact

Prof Laila AL-Ayadhi

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2011-2

Study information

Scientific title

The therapeutic possibilities of camel milk in autism spectrum disorders: a longitudinal interventional single-blinded single centre trial

Acronym

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.)

Ethics approval

Institutional Review Board approved on 23rd March 2011 (ref: 11/2967/IRB)

Study design

Longitudinal interventional single-blinded single centre trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Professor Al-Ayadhi [ayadh2@gmail.com] to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Camel milk

Primary outcome measures

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 trial start date

10/01/2011

Overall trial end date

10/01/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

10/01/2011

Recruitment end date

10/01/2013

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

Autism Research and Treatment Centre
Riyadh
11461
Saudi Arabia

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

http://twahud.com

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes