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A randomized, double-blind, placebo-controlled study: the effects of probiotic lactobacillus L168 on behavioral improvement in patients with autism

A randomized, double-blind, placebo-controlled study: the effects of probiotic lactobacillus L168 on behavioral improvement in patients with autism

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045362
Enrollment
Unknown
Registered
2021-04-13
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-11-22

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

Conditions

Autism spectrum disorder

Interventions

experimental group:Lactobacillus plantarum L168 powder (2g / bag, 30 billion CFU / bag)
control group:Placebo (maltodextrin, 2g/bag)

Sponsors

Nanjing Brain Hospital Affiliated to Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 9 Years

Inclusion criteria

Inclusion criteria: 1.Autistic patients with behavioral disorders aged 3-9 years; 2.Priority is given to autistic people with intestinal symptoms such as constipation or diarrhea; 3.The drug of various kinds of anti-microbial, prebiotic and diet-treatment, immunosuppressive drug, high dose vitamin and other simultaneous drug-based treatment were stopped for more than 1 month; 4.The family members signed the informed consent form voluntarily, and could insist on the treatment of follow-up patients, and the parents were healthy without any diseases that seriously affected the normal life, work, thinking and judgment ability.

Exclusion criteria

Exclusion criteria: 1.Patients with diseases of other nervous system and that seriously affect the quality of life caused by other reasons. 2.The patients' family members couldn't cooperate; 3.Patients are participating in other research projects.

Design outcomes

Primary

MeasureTime frame
Autism Treatment Evaluation Check List (ATEC);Childhood Autism Rating Scale (CARS);Gastrointestinal Symptom Rating Scale (GSRS);

Secondary

MeasureTime frame
Serum serotonin;Serum tryptophan;Serum dopamine;Immune factor L-17;Immune factor L-6;Immune factor L-4;Immune factor L-10;Structure of intestinal flora;Food intolerance;Blood ammonia;Lactic acid;Pyruvic acid;Homocysteine;Carnitine spectrum;Urine metabolism screening;

Countries

China

Contacts

Public ContactLiu Xingyin
xingyinliu@njmu.edu.cn+86 15365182836

Outcome results

None listed

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