Impact of Probiotics on Children With ADHD

Wecare Probiotics

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06348121

WK2024003

Details and patient eligibility

About

This study investigates WecProB (Bifidobacterium animalis subsp. lactis and Lacticaseibacillus rhamnosus) to evaluate their potential to improve symptoms and safety in children with ADHD.

Enrollment: 50 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of ADHD per DSM-5 criteria;
2. Age 6-12 years, gender-neutral;
3. IQ >70 on intelligence testing;
4. Participant/guardian comprehension and voluntary consent.

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.;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Probiotic group

Experimental group

Description:

5B CFU/strip/day WecProB, before meal

Treatment:

Dietary Supplement: Probiotic