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Effect evaluation of synbiotics on anorexia nervosa

Effect evaluation of synbiotics on anorexia nervosa: randomized controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071230086
Enrollment
40
Registered
2023-11-08
Start date
2024-02-09
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Anorexia Nervosa Anorexia Nervosa

Interventions

Randomized controlled trial: AN patients will be randomly assigned to receive SynB or placebo, and the treatment effect will be evaluated at baseline, 6 weeks after starting, and 12 weeks after starti

Sponsors

Sudo Nobuyuki
Lead Sponsor
Hata Tomokazu
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Persons who have given written consent of their own free will 2) Female inpatients who are at least 12 years old and less than 49 years old at the time consent is obtained 3) Patients who meet the diagnostic criteria for the diagnosis of neurotic emaciation in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) published by the American Psychiatric Association in a structured interview. Any duration of illness is acceptable. 4) Patients who are less than 75% of standard body weight and eligible for our inpatient treatment program "Cognitive Behavioral Therapy with Behavioral Restraints" (patients who are not in a state of physical crisis and are capable of restoring nutritional status and working on psychological tasks)

Exclusion criteria

Exclusion criteria: 1) Patients with known complications of physical illness or other psychiatric disorders (such as schizophrenia or bipolar disorder) 2) Patients who have received antibiotics or treatment with central venous nutrition within 3 months prior to entry 3) Patients with arrhythmias or infections due to extremely low nutrition, or in a state of physical crisis (electrolyte abnormalities with panic values such as sodium below 120 mEq/L and potassium below 2.5 mEq/L)

Design outcomes

Primary

MeasureTime frame
Compare "weight gain per energy intake" to verify the superiority of SynB administration.

Secondary

MeasureTime frame
Questionnaire: changes in mental and physical symptoms, blood tests, enterobacterial analysis (fecal, blood), metabolome analysis, uremic toxin measurement, microRNA analysis, EEG, MRI analysis.

Contacts

Public ContactTomokazu Hata

Department of Psychosomatic Medicine, Kyushu University Hospital

hata.tomokazu.780@m.kyushu-u.ac.jp+81-92-642-5318

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026