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Clinical study of the effects associated with oral administration of Limosilactobacillus reuteri LR99 to children with attention deficit hyperactivity disorder

Clinical study of the effects associated with oral administration of Limosilactobacillus reuteri LR99 to children with attention deficit hyperactivity disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097119
Enrollment
Unknown
Registered
2025-02-12
Start date
2025-02-13
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention deficit hyperactivity disorder, ADHD

Interventions

Lactobacillus reuteri LR99 combined with behavioral intervention group (LR99 group):The probiotic preparation was taken once a day for 12 weeks. The oral probiotic was Limosilactobacillus reuteri LR99
Behavioral intervention group:Purely behavioral intervention group

Sponsors

Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Children aged 6-12 who are enrolled in primary school; (2) Meets DSM-5 diagnostic criteria for ADHD; (3) have not taken ADHD treatment drugs in the past; (4) Parents voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Age < 6 years or over 12 years old; (2) Use of various antifungal drugs, antibiotic drugs, immunosuppressive drugs, and antipsychotic drugs (package) in the past month including ADHD treatments) and other alternative therapies of probiotics, prebiotics, macronutrients and others; (3) Have AIDS, Crohn's disease, ulcerative colitis or cancer; (4) receiving chemotherapy; (5) Other unstable or serious heart, pulmonary, hepatic, kidney, hematopoietic system diseases (including unstable angina, uncontrollable asthma, severe allergies, active gastric bleeding, acute leukemia, etc.).

Design outcomes

Primary

MeasureTime frame
SNAP-IV questionnaire;Results of cytokine detection and analysis of saliva and stool microbiota;

Secondary

MeasureTime frame
Conners questionnaire;Weiss Functional impairment Rating Scales;Follow-up was terminated for various reasons through the start of the study through 12 weeks;

Countries

China

Contacts

Public ContactLi Jie

Sichuan Provincial People's Hospital

583525662@qq.com+86 159 2898 6859

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026