For the group of the date 1, Diagnosed autistic patients will be given three pieces of Dates will be given on daily basis for 12 weeks as follow: Three pieces (each about 10 -15 gm), of Dates, will be taken with breakfast or between breakfast and lunch as a test dose daily (without drinking any tea after it by at least one hour).

For the group of the date 2, Diagnosed autistic patients matched for age and sex will be given five pieces of Dates will be given on daily basis for 12 weeks as follow: five pieces (each about 10 -15 gm), of Dates, will be taken with breakfast or between breakfast and lunch as a test dose daily (without drinking any tea after it by at least one hour).

Group 3 (no- Dates fruit group): Diagnosed autistic patients matched for age and sex will not receive any dates

Autistic Spectrum Disorder

Two groups will receive Dates; The number per group is dependant on the child age. For children aged 3-6 years; they will receive the minimum numbers of dates (3 pieces). For children aged more than 6-12 years will receive 5 pieces of Dates the choice of the minimum numbers of dates (3 pieces) in this current trial is based on a study that was done by Al Jaouni and his colleagues, 2019 which proved the effects of three pieces of Ajwa on infection, hospitalization, and survival among 26 pediatric cancer patients in a university hospital; for which their treatment outcome was improved due to their intake of this amount of Ajwa during their standard treatment

Dates fruit as functional Food

Behavioral modification applied to the autistic children that is based on applied behavior analysis (ABA), a widely accepted approach that tracks a child's progress in improving his or her skills. We use Positive Behavioral and Support (PBS)

behavioral modification and stimulation

The nutritional education sessions are based on educating parents on providing their autistic children with a nutritious, balanced diet. Because children with ASD often have restricted diets as well as difficulty sitting through meal times, they may not be getting all the nutrients they need, particularly calcium and protein

nutritional Guidance

National Research Centre

Dates as a Functional Food for Autism

Evaluating Dates as a Functional Food for Autism Via Its Prebiotic Effect, Modulation of Anti-Inflammatory and Anti-Oxidative Activity.

comparing blood levels of three oxidative markers; Malondialdehyde (MDA), glutathione peroxidase (GPX1) and superoxide dismutase (SOD) in children with autism for the three proposed regimen. Measuring the difference pre and three months after the intervention, before and six months after the intervention

Through the quantitative PCR (qPCR) for the change in the presence and absence of the targeted bacterial subgroups (including Bifidobacterium, lactobacillus, Clostridium, Sutterella)

by DNA extraction kits of the fecal samples and Real-time PCR before and after interventions we will measure the change in the presence of the probiotics before and after the intervention

Mental Development, Psychomotor Development and Behavior Rating will be assessed by using the "Bailey Scales of Infant and Toddler Development", the cognitive, language, and motor abilities will be assessed; as well as social-emotional and adaptive behavior. Mental and psychomotor developmental quotients and mental age will be scored as well as the behavioral profile. The Bailey Screening Test is an Observation Checklist for 5 domains of development (cognitive, language, motor, social-emotional, & adaptive behavior).

comparing changes the severity of autism as a result of interventions according Diagnostic and statistical manual of mental disorders, 5th ed. (DSM-V) criteria it measure specific ASD symptom severity All core features of ASD are included: socialisation impairments, communication deficits and repetitive or restricted interests, including sensory abnormalities. After a period of interactive play, the observer rates the child's behaviour, comparing it to that of his/her age group. Each item is given a numerical score of '0' (indicating no impairment), '1' (indicating mild impairment), or '2' (indicating severe impairment)

comparing changes the severity of autism as a result of interventions according to CARS.Each item on the Clinician-Rated Severity of Autism Spectrum and Social Communication Disorders measure is rated on a 4-point scale (Level 0=None; Level 1=Mild/Requiring support; Level 2=Moderate/Requiring SUBSTANTIAL support; and Level 3=Severe/Requiring VERY SUBSTANTIAL support).

comparing changes on eating behaviors as assessed by the 24 hours intake and food pattern. Dietary intake is difficult to measure, and any single method cannot assess dietary exposure perfectly. The 24HR, and FFQ are subjective estimates. Recently, it has been suggested that a combination of methods, such as the FFQ with 24HR be used to obtain more accurate estimates of dietary intakes than that of individual methods. They are widely used as the primary dietary assessment tool in epidemiological studies..

all IPD that underlie results in a publication will be shared

Prof.Dr. Ammal Mokhtar Metwally

Principal Investigator

National Research Center, Egypt

Dates and their constituents show a role in disease prevention through anti-oxidant, anti-inflammatory, anti-bacterial activity. Dates are considered a staple food item in the Middle East and North Africa and are also imported in Europe, the UK, and the USA. (12).
Dates' therapeutic effect in the management of the disease via its anti-oxidant, anti-inflammatory effect and for the sake of autistic children, is worthy to point and essential to evaluate Dates as a good remedy for autistic children because it is inexpensive and easy to access.

A randomized placebo-controlled, parallel-group study, crossover-design. Intervention: Sanprobi Barrier-multispecies probiotic product, 2,5 x10 9 cfu/gram or placebo, cross-over design

A randomized placebo-controlled, parallel-group study, crossover-design. Intervention: placebo comparator (carrier material of Sanprobi Barrier-multispecies probiotic product , not containing bacterial strains,similar appearance as the probiotic, cross-over design

Diabetes Mellitus, Type 2

Metformin Adverse Reaction

Multi-strain probiotic Sanprobi Barrier (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus lactis W19, Lactobacillus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Lactobacillus salivarius W24) or placebo. Patients will be randomized to one of the two products ("A" or "B") each containing probiotic/placebo and administered for 12 weeks. After 12 weeks of supplementation, the probiotic/placebo product "A" or "B" will be discontinued and reintroduced again after next 4 weeks - patients will be switched to the other "A or B" group of probiotic/placebo arm. Patients will be administered with 4 capsules per day for 24 weeks (12 weeks for group A probiotic/placebo and 12 weeks for group B probiotic/placebo allowing 4 weeks washout between the group assignment).

Sanprobi Barrier-multispecies probiotic

Carrier material of Sanprobi Barrier-multispecies probiotic product, not containing bacterial strains,similar appearance as the probiotic

Placebo Comparator

Department of Internal Diseases, Diabetology and Nephrology

Probiotics in Metformin Intolerant Patients With Type 2 Diabetes

The Effect of Multi-strain Probiotics on Gastrointestinal Symptoms in Patients With Type 2 Diabetes and Metformin Intolerance. A 32-week Prospective, Single Center, Randomized, Placebo Controlled, Cross-over Clinical Trial.

Questionnaire to Assess Character and Severity of Metformin Intolerance (adapted from Laura J. Mc Creight et al.). The score indicates how the patient tolerates metformin.
Score interpretation:
0 - 10 = tolerant (T) 11-20 = mild intolerance (MI) 21-30 = intolerant (I) 31-50 = severely intolerant (SI)

assessment of short chain fatty acids in stool (gas chromatography)

Medical University of Silesia

Sanprobi Sp. z o.o., Sp. k., Szczecin, Poland

prospective, single center , interventional

Cystic Fibrosis

Randomized to receive either 20mg/d zinc as zinc acetate or an identical placebo

superoxide dismutase/diarrhea

Dates as a Functional Food for Autism

Probiotics in Metformin Intolerant Patients With Type 2 Diabetes

Zinc Homeostasis and Kinetics in Children With Cystic Fibrosis (CF)

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