Status:

RECRUITING

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

Lead Sponsor:

Ain Shams University

Conditions:

Antipsychotic Induced Weight Gain

Eligibility:

All Genders

18-45 years

Phase:

PHASE3

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.
  • \-

Key Trial Info

Start Date :

April 20 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 20 2026

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT06936137

Start Date

April 20 2025

End Date

December 20 2026

Last Update

April 20 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

AinShams university hospitals

Cairo, Abbassia, Egypt, 00202