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

Recruiting now · Phase 3

Conditions studied: Antipsychotic Induced Weight Gain

In brief

the goal of the study is to improve the quality of life of patients on antipsychotic medications and increase the rate of compliance to treatment. Primary objective: 1.To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications. Secondary objective: 1\. To determine the effect of probiotic supplementation on the psychological state of patients.

Key facts

Study ID

NCT06936137

Run by

Ain Shams University

People needed

180

Starts

2025-04-20

Expected to finish

2026-12-20

Last updated by the study team

2025-04-20

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks.
• Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases.

Where it is running

• AinShams university hospitals — Cairo, Abbassia, Egypt (enrolling)

Full record on ClinicalTrials.gov

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