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Gut-brain-axis effects of Bifidobacterium longum subsp. longum dipro-X against anxiety in children: A randomized, double-blind, placebo-controlled clinical trial

Gut-brain-axis effects of Bifidobacterium longum subsp. longum dipro-X against anxiety in children: A randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126806
Enrollment
Unknown
Registered
2026-06-16
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Anxiety Disorder

Interventions

Intervention group:Receiving intervention with the Bifidobacterium longum subsp. longum strain dipro-X preparation
Control group:Receiving placebo intervention

Sponsors

Shanghai Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.Aged 12 to 18 years old, no limitation on gender; 2.Scoring =25 points on the SCARED scale; 3.Participants and their legal guardians must provide written informed consent for participation in this interventional study and exhibit the ability to understand and comply with the study protocol.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with major depressive disorder; 2. Diagnosed with neuropsychiatric disorders such as autism spectrum disorder, attention-deficit/hyperactivity disorder, bipolar disorder, intellectual disability, schizophrenia, or a history of epilepsy; 3. History of head trauma, other unstable major physical illnesses, or physical diseases that may cause psychiatric symptoms; 4. Currently receiving psychotherapy and/or psychotropic medication intervention; 5. Obvious suicidal tendency; 6. Intellectual disability; 7. Participation in other clinical intervention studies involving drugs, dietary supplements, probiotics, or prebiotics within the past 3 months; 8. Severe infection or severe trauma as determined by the investigator, or having undergone moderate to major surgery within the past month; 9. Allergy to known ingredients of probiotic products; 10. Other reasons deemed by the investigator as making the subject unsuitable for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
Anxiety Scale Score(HAMA);

Secondary

MeasureTime frame
Depression Scale Score;Self-esteem Scale Score;Sleep Quality Scale Score;Gut metabolites;Gut microbiota;

Countries

China

Contacts

Public ContactZhu Daqian

Shanghai Children's Hospital

zhudaqian2003@163.com+86 139 1662 0691

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026