Attention Deficit Hyperactivity DisorderNCT04333394
Effectiveness of Probiotic Supplement In Improving Attention Deficit Hyperactivity Disorder Symptoms
A study testing Probiotic in people with Attention Deficit Hyperactivity Disorder, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
To study the effects of probiotic supplement in children with Attention-deficit hyperactivity disorder (ADHD),40 patients will be randomly allocated to two groups of intervention and placebo. The intervention and the placebo group will be prescribed with 1 capsule of probiotics and placebo for 8 weeks, respectively. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 20 Apr 2020to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of Attention Deficit Hyperactivity Disorder
- Having an Intelligence quotient more than 85 based on Wechsler test for children
- Willing to participate in the study
Who cannot join
- History of any other mental and psychological disorder such as depression, chronic motor tic disorder, communication disorder, learning disability
- Taking any stimulant, sedative, anti-anxiety and anti-psychotic medications
- History of any chronic disorders, requiring long term medication (such as cancers, Cirrhosis, autoimmune disorders, metabolic disorders ) or, chronic neurological disorders (such as epilepsy)
Trial locations and contacts
1 site in 1 country.
Azita Hekmatdoost contact
Iran1 site
National Nutrition and Food Technology Research Institute
Tehrān, Tehran Province, 19395-4741
About this study
Official title: Investigating the Effectiveness of Probiotic Supplement in Improving Attention Deficit Hyperactivity Disorder Symptoms in Children
To study the effects of probiotic supplement in children with Attention-deficit hyperactivity disorder (ADHD),40 patients will be randomly allocated to two groups of intervention and placebo. The intervention and the placebo group will be prescribed with 1 capsule of probiotics and placebo for 8 weeks, respectively. Treatment efficacy will be assessed via administrating the Conners's rating
Read the detailed description
Both probiotics and placebo groups will receive medication with Ritalin in a dose-dependent manner, starting at the onset of the study and simultaneous with probiotic supplementation. Children weighed 30 Kg or less receive 0.3 mg/kg of Ritalin in 3 separate intervals and after four weeks the dosage will increase to 0.5mg/kg. Those who weighed more than 30 kg receive 0.5 mg/kg with the same pattern that reaches the highest point of 0.7 mg/kg by week four. Each dosage will be administrated trice a day with breakfast, lunch, and dinner. In the middle of the study patients who consumes less than 80% of their supplements will be omitted from the study.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Probiotic, Placebo
- Keywords
- ADHD, Probiotics, Children
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The probiotic capsules will be administrated once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with probiotic supplementation.
PlaceboOther
The placebo capsules will be administered once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with placebo supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | The probiotics capsules contain 7 strains of friendly bacteria (Lactobacillus casei PXN 37, Lactobacillus rhamnosus PXN 54, Streptococcus thermophilus PXN 66, Bifidobacterium breve PXN 25, Lactobacillus acidophilus PXN 35, Bifidobacterium longum PXN 30, Lactobacillus bulgaricus PXN 39) Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms of Attention-deficit hyperactivity disorder (ADHD)
symptoms were assessed using Conners's scale
Measured: 8 weeks
The severity of the Attention-deficit hyperactivity disorder (ADHD)
The severity of the ADHD was assessed using the Clinical Global Impression (CGI) test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start20 Apr 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Parallel groups
- Model description
- The present study will be conducted as a phase 3, randomized double-blind placebo-controlled trial on 40 attention deficit hyperactivity disorder patients allocated in 2 parallel groups each consisted of 20 patients who will receive Probiotic or placebo. From the beginning of the study, A and B codes are available to researchers to recruit the patients using ten 4-Block Randomization.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
- Investigators
- Soodeh Razeghi Jahromi, PhD, Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333394
- Sponsor's protocol ID
- 96/114
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Probiotic Supplement in Improving Attention Deficit Hyperactivity Disorder Symptoms in Children
- ClinicalTrials.gov ID
- NCT04333394
- Acronym / sponsor ID
- 96/114
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Probiotics, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 3 Apr 2020 (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.
To study the effects of probiotic supplement in children with Attention-deficit hyperactivity disorder (ADHD),40 patients will be randomly allocated to two groups of intervention and placebo. The intervention and the placebo group will be prescribed with 1 capsule of probiotics and placebo for 8 weeks, respectively. Treatment efficacy will be assessed via administrating the Conners's rating
Detailed description
Both probiotics and placebo groups will receive medication with Ritalin in a dose-dependent manner, starting at the onset of the study and simultaneous with probiotic supplementation. Children weighed 30 Kg or less receive 0.3 mg/kg of Ritalin in 3 separate intervals and after four weeks the dosage will increase to 0.5mg/kg. Those who weighed more than 30 kg receive 0.5 mg/kg with the same pattern that reaches the highest point of 0.7 mg/kg by week four. Each dosage will be administrated trice a day with breakfast, lunch, and dinner. In the middle of the study patients who consumes less than 80% of their supplements will be omitted from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study will be conducted as a phase 3, randomized double-blind placebo-controlled trial on 40 attention deficit hyperactivity disorder patients allocated in 2 parallel groups each consisted of 20 patients who will receive Probiotic or placebo. From the beginning of the study, A and B codes are available to researchers to recruit the patients using ten 4-Block Randomization.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticThe probiotics capsules contain 7 strains of friendly bacteria (Lactobacillus casei PXN 37, Lactobacillus rhamnosus PXN 54, Streptococcus thermophilus PXN 66, Bifidobacterium breve PXN 25, Lactobacillus acidophilus PXN 35, Bifidobacterium longum PXN 30, Lactobacillus bulgaricus PXN 39) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules have an identical appearance to probiotic capsules and contain microcrystal cellulose. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of Attention Deficit Hyperactivity Disorder
- Having an Intelligence quotient more than 85 based on Wechsler test for children
- Willing to participate in the study
Key exclusion criteria (3 listed)
- History of any other mental and psychological disorder such as depression, chronic motor tic disorder, communication disorder, learning disability
- Taking any stimulant, sedative, anti-anxiety and anti-psychotic medications
- History of any chronic disorders, requiring long term medication (such as cancers, Cirrhosis, autoimmune disorders, metabolic disorders ) or, chronic neurological disorders (such as 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 |
|---|---|---|
| ProbioticThe probiotic capsules will be administrated once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with probiotic supplementation. | Dietary supplement | Probiotic |
| PlaceboThe placebo capsules will be administered once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with placebo supplementation. | Other | Placebo |
Primary outcome
symptoms of Attention-deficit hyperactivity disorder (ADHD)
Time frame: 8 weeks
symptoms were assessed using Conners's scale
The severity of the Attention-deficit hyperactivity disorder (ADHD)
Time frame: 8 weeks
The severity of the ADHD was assessed using the Clinical Global Impression (CGI) test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
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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. This study is not recruiting at the moment.
Azita Hekmatdoost contact
Soodeh Razeghi Jahromi, PhD study director
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Attention Deficit Hyperactivity Disorder, run by National Nutrition and Food Technology Institute at 1 site in Iran.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azita Hekmatdoost, MD.PhD (2122357484, a_hekmat2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptoms of Attention-deficit hyperactivity disorder (ADHD) (time frame: 8 weeks). 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?
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 Apr 2020.