: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)

Launched by AIN SHAMS UNIVERSITY · Apr 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether taking probiotics can help reduce weight gain caused by certain antipsychotic medications in patients with schizophrenia. Antipsychotics can sometimes lead to increased weight, which may affect a patient's overall health and quality of life. The researchers want to see if probiotics, which are beneficial bacteria that can improve gut health, can help patients manage their weight better and possibly improve their mood as well.

To participate in the study, you would need to be an adult aged 18 to 45 who has been taking specific antipsychotic medications for at least three months and has gained more than 10% of your body weight during that time. However, you cannot have any serious digestive issues or have taken certain supplements or medications in the last six weeks. If you join the trial, you will be part of a group that receives the probiotic or a placebo (a pill with no active ingredients) and will be monitored to see how it affects your weight and mental health. This study is currently recruiting participants, and your involvement could help improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult schizophrenia patients (18-45 years) on second generation antipsychotics Stable patients with a total positive and negative syndrome scale (PANSS) score of ≤60.
• • With more than 10% weight gain after taking atypical antipsychotics for at least 3 months with treatment duration not more than two years.
• Exclusion Criteria:
• • 1. Taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks.
• • 2. Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases.
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