Impact of Probiotics on Children With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Effect of WecProB on Clinical Features and Gut Microbiota of Attention Deficit Hyperactivity Disorder in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348121
• Other study ID #: WK2024003
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 7, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Wecare Probiotics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of probiotic product WecProB as food supplements for the treatment of clinical symptoms in children with ADHD, in comparison with placebo.

Description:

Randomized groups were given a combination of probiotics or placebo in addition to treatment with a consistent dose (1.2 mg/kg/d) of conventional ADHD medication (atomoxetine). The total length of the study is 12 weeks, and at weeks 0, 4, 8 and 12 weeks of the trial, the clinical symptoms of ADHD will be assessed using a scale. Blood and stool samples will be collected at weeks 0 and 12, and psychological tests will be performed. Nucleic acid sequencing technology was used to identify bacterial species in feces, and high-throughput 16S rRNA sequences were quickly obtained by sequencing, and fecal metabolites were analyzed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

1. Meet the diagnostic criteria for ADHD in DSM-V;

2. IQ>70;

3. Male aged 6-14 years.

Exclusion Criteria:

1. Those with a clear history of other serious neurological diseases, such as epilepsy, head trauma, encephalitis or meningitis, etc.;

2. Have taken antibiotics, probiotics or immunosuppressants within one month before starting the experiment;

3. Ongoing special diet, such as ketogenic diet, etc

4. BMI higher than the 90th percentile or lower than the 10th percentile for children of the same age and sex;

5. Those who have had symptoms of respiratory or digestive tract infection in the past month, such as fever, cough, diarrhea, etc.;

6. Those who have had inflammatory bowel disease in the past, such as ulcerative colitis, Crohn's disease, etc.;

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Dietary Supplement:
• Probiotic
The experimental phase of the study had last 84 days, and each patient will make 4 visits (d0, d28, d56, d84).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wecare Probiotics Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical symptoms of ADHD	The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), was employed to assess the executive functioning deficits commonly associated with ADHD in children. The BRIEF-2 scale ranges from a minimum of 0 to a maximum of 300 points. Higher scores on the BRIEF-2 indicate greater executive dysfunction, meaning that a higher score reflects worse outcomes.	84 days