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

Last updated: April 18, 2025
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Treatment

lactobacillus LS

Clinical Study ID

NCT06936137
MD343/2024
  • Ages 18-45
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult schizophrenia patients (18-45 years) on second generation antipsychoticsStable 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

Exclusion Criteria:

  1. Taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks.

  2. Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled andrecurrent diarrhea, gastrointestinal bleeding, and digestive system neoplasticdiseases.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: lactobacillus LS
Phase: 3
Study Start date:
April 20, 2025
Estimated Completion Date:
December 20, 2026

Connect with a study center

  • AinShams university hospitals

    Cairo, Abbassia 00202
    Egypt

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.