Autism Spectrum Disorder (ASDAPITSANCT06756711
Combination of Supplements for Treating Autistic Spectrum Disorder
A study testing A combination of apitherapy and plant extracts in people with Autism Spectrum Disorder (ASD, run by Fundatia Bio-Forum at 2 sites in Romania.
Trial summary
A pilot study to compare the efficacy of a combination of apitherapy supplements versus placebo in children with autistic spectrum disorder. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD
- What is being tested?
- A combination of apitherapy and plant extracts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesRomania
- Study dates
- 10 Dec 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 3-14 years
- diagnosed with typical or atypical autism spectrum disorder (F84.0 or F84.1) and received at least one therapeutic intervention before enrolling
- the ability to follow an oral treatment, with TID/BID/QD administration
- the availability to perform 3 sets of blood tests at a clinical laboratory within 6 months (initial, at 3- and 6-months)
- the availability to perform 3 visits to the Investigator and 3 psychometric evaluations within 6 months
Who cannot join
- patients enrolled in another interventional clinical trial currently or which ended less than 1 month prior to enrolling in this study
- known allergy to hive products or one of the substances studied
- inability to perform the study requirements (3 visits to the Investigator, 3 psychometric assessments, 3 sets of blood tests)
- diagnosis of diabetes
- history of seizures/epilepsy
- administration of anticoagulants, antiplatelets, thrombolytic agents, low molecular weight heparins, anticonvulsants, insulin, monoamine oxidase inhibitors, non-steroidal anti-inflammatory drugs or thiazide diuretics
- allergy to celery and other plants of the Fam. Apiaceaea (Umbelliferae)
- abnormally elevated baseline (at V1) values of ferritin, homocysteine, HgbA1c, ESR
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Romania2 sites
Clinica Aide Sante
Bucharest, 040245
Medical Link SRL
Constanța, 900654
About this study
A pilot study to compare the efficacy of a combination of apitherapy supplements versus placebo in children with autistic spectrum disorder.
Read the detailed description
A prospective, double-blind, placebo-controlled, crossover, multicentre clinical study which will enrol up to 45 children diagnosed with ASD (enrolment will stop when 40 children have completed the study). Children ages 3-14 will be tested before and after administering the combination of active substances (3 months) and placebo (3 months). The duration of participation in the study for each child will be 6 months. The supplements tested consist of three products - a combination of apitherapy and plant extracts - which have been approved for sale as individual supplements for more than 5 years in Romania - Apicol 12 gamma, Laptisor de matca activat (Royal Jelly) and Telom R Cerebral. Participation in the study is free and all children will be comparatively evaluated with the ATEC and ASRS scales and three sets of blood tests.
- Conditions
- Autism Spectrum Disorder (ASD
- Being tested
- A combination of apitherapy and plant extracts, Placebo Combination
- Keywords
- Autistic Spectrum Disorder, apitherapy, brain aromatase
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A combination of apitherapy and plant extractsDietary supplement
This combination contains the active comparator
Placebo CombinationCombination product
A combination containing inert substances - placebo
| Study group | Role | What they receive |
|---|---|---|
| Active combination | Active comparator | A combination of 3 supplements with royal jelly and various plant extracts Receives: Dietary Supplement: A combination of apitherapy and plant extracts |
| Placebo combination | Placebo comparator | A combination of 3 products with identical look and colour Receives: Combination Product: Placebo Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification on ATEC score
Total ATEC (Autism Treatment Evaluation Checklist) scores before and after each intervention, as well subscale scores; higher scores indicate worse status, score range between 0 (minimal, absence of pathology), to 180 - maximal intensity of symptoms
Measured: 3 months each of administration of active treatment and respectively placebo
Modification of ASRS scores
Scores on Autism Spectrum Rating Scales (ASRS) tests, total and 8 subscales will be compared before and after each intervention; total scores vary between 50-255, with higher score indicating more severe symptoms
Measured: 3 months each of administration of active treatment and respectively placebo
Secondary outcomes (1)
NSE level modifications
Changes in the levels of serum Neuron-specific enolase (NSE) will be compared between the two arms, higher levels indicate higher neuronal destruction
Measured: 3 months each of administration of active treatment and respectively placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start10 Dec 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective, double-blind, placebo-controlled, crossover, multicenter
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundatia Bio-Forum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felician Stancioiu, M.D., Principal investigator, Fundatia Bio-Forum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756711
- Sponsor's protocol ID
- BF-045
- Acronym
- APITSA
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stancioiu F, Bogdan R, Dumitrescu R. Neuron-Specific Enolase (NSE) as a Biomarker for Autistic Spectrum Disease (ASD). Life (Basel). 2023 Aug 13;13(8):1736. doi: 10.3390/life13081736.
PubMed 37629593
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Supplements for Treating Autistic Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06756711
- Acronym / sponsor ID
- APITSA / BF-045
- Conditions
- Autism Spectrum Disorder (ASD
- Keywords
- Autistic Spectrum Disorder, apitherapy, brain aromatase
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundatia Bio-ForumUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study to compare the efficacy of a combination of apitherapy supplements versus placebo in children with autistic spectrum disorder.
Detailed description
A prospective, double-blind, placebo-controlled, crossover, multicentre clinical study which will enrol up to 45 children diagnosed with ASD (enrolment will stop when 40 children have completed the study). Children ages 3-14 will be tested before and after administering the combination of active substances (3 months) and placebo (3 months). The duration of participation in the study for each child will be 6 months. The supplements tested consist of three products - a combination of apitherapy and plant extracts - which have been approved for sale as individual supplements for more than 5 years in Romania - Apicol 12 gamma, Laptisor de matca activat (Royal Jelly) and Telom R Cerebral. Participation in the study is free and all children will be comparatively evaluated with the ATEC and ASRS scales and three sets of blood tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, double-blind, placebo-controlled, crossover, multicenter
| Arm | Type | Receives |
|---|---|---|
| Active combination | Active comparator | Dietary Supplement: A combination of apitherapy and plant extractsA combination of 3 supplements with royal jelly and various plant extracts |
| Placebo combination | Placebo comparator | Combination Product: Placebo CombinationA combination of 3 products with identical look and colour |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age 3-14 years
- diagnosed with typical or atypical autism spectrum disorder (F84.0 or F84.1) and received at least one therapeutic intervention before enrolling
- the ability to follow an oral treatment, with TID/BID/QD administration
- the availability to perform 3 sets of blood tests at a clinical laboratory within 6 months (initial, at 3- and 6-months)
- the availability to perform 3 visits to the Investigator and 3 psychometric evaluations within 6 months
Key exclusion criteria (8 listed)
- patients enrolled in another interventional clinical trial currently or which ended less than 1 month prior to enrolling in this study
- known allergy to hive products or one of the substances studied
- inability to perform the study requirements (3 visits to the Investigator, 3 psychometric assessments, 3 sets of blood tests)
- diagnosis of diabetes
- history of seizures/epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A combination of apitherapy and plant extractsThis combination contains the active comparator | Dietary supplement | Active combination |
| Placebo CombinationA combination containing inert substances - placebo | Combination product | Placebo combination |
Primary outcome
Modification on ATEC score
Time frame: 3 months each of administration of active treatment and respectively placebo
Total ATEC (Autism Treatment Evaluation Checklist) scores before and after each intervention, as well subscale scores; higher scores indicate worse status, score range between 0 (minimal, absence of pathology), to 180 - maximal intensity of symptoms
Modification of ASRS scores
Time frame: 3 months each of administration of active treatment and respectively placebo
Scores on Autism Spectrum Rating Scales (ASRS) tests, total and 8 subscales will be compared before and after each intervention; total scores vary between 50-255, with higher score indicating more severe symptoms
1 secondary outcome
NSE level modifications
Time frame: 3 months each of administration of active treatment and respectively placebo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 37629593Stancioiu F, Bogdan R, Dumitrescu R. Neuron-Specific Enolase (NSE) as a Biomarker for Autistic Spectrum Disease (ASD). Life (Basel). 2023 Aug 13;13(8):1736. doi: 10.3390/life13081736.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felician Stancioiu, M.D. principal investigator
Fundatia Bio-Forum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A combination of apitherapy and plant extracts in people with Autism Spectrum Disorder (ASD, run by Fundatia Bio-Forum at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification on ATEC score (time frame: 3 months each of administration of active treatment and respectively placebo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.