Attention-Deficit/Hyperactivity Disorder
Conditions
Interventions
Smectite group:Patients accept two periods of smectite treatment over 4 (2+2) weeks. Take one dose for the first two weeks and another for the second two weeks.
Placebo-controlled group:Patients accept two periods of placebo treatment over 4 (2+2) weeks. Take one dose for the first two weeks and another for the second two weeks.
Sponsors
Xijing Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: A diagnosis of ADHD based on the Diagnostic and Statistical Manual (DSM-V) criteria for Attention deficit/hyperactivity disorder; Males and females aged 6 to 12 years.
Exclusion criteria
Exclusion criteria: Combined with other mental and neurodevelopmental disorder (such as ASD, Tic disorder, anxiety disorder, major depressive disorder, conduct disorder) or epilepsy; The IQ score of the participants is below 75; Oral, injected, inhaled antibiotic within 30 days prior to Screening; Currently taking a controlled- or extended-release medication related to ADHD; Severe constipation; History of inflammatory bowel disease, bowel obstruction, diverticulosis or colon polyps; History of significant gastric or intestinal surgery (excluding appendectomy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SNAP-IV 26-Item Parent Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global lmpression-Severity scale (CGI-S);Clinical Global lmpression-lmprovement scale (CGI-I);Screen for Child Anxiety Related Disorders (SCARED);Sleep Disturbance Scale for Children (SDSC);Gastrointestinal Symptom Rating Scale (GSRS);The change of metabolites in plasma, urine and stool in children with ADHD before and after treatment;The change of gut microbiome in children with ADHD before and after treatment; | — |
Countries
China
Contacts
Public ContactYan Li
The First Affiliated Hospital of Xi’an Jiaotong University
Outcome results
None listed