Effect evaluation of synbiotics on anorexia nervosa

JRCT ID: jRCTs071230086

Registered date:08/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Anorexia Nervosa
• Date of first enrollment: 09/02/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): 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 starting. To ensure that the investigators (physicians) and study subjects (patients) are unable to distinguish between SynB and placebo, the comparative study will use a double-blind approach.

Outcome(s)

• Primary Outcome: Compare "weight gain per energy intake" to verify the superiority of SynB administration.
• Secondary Outcome: Questionnaire: changes in mental and physical symptoms, blood tests, enterobacterial analysis (fecal, blood), metabolome analysis, uremic toxin measurement, microRNA analysis, EEG, MRI analysis.

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 49age old
• Gender: Female

Include 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)

Exclude 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)

Related Information

• Primary Sponsor: Sudo Nobuyuki
• Secondary Sponsor: Hata Tomokazu