Impact of Probiotics on Children With ADHD

Not Applicable

Not yet recruiting

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT06348121
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Status Verified: 2024-04
• Study First Posted: 2024-04-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26
• Study Start: 2024-05-07
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

1. Meet the diagnostic criteria for ADHD in DSM-V;
2. IQ>70;
3. Male aged 6-14 years.

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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.;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Probiotic	Maltodextrin, one bag/day, before meal
Probiotic group	Probiotic	one bag/day WecProB, before meal

Primary Outcome Measures

Name	Time	Method
Clinical symptoms of ADHD	84 days	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.