RecruitingPhase 3NCT06936137

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


Sponsor

Ain Shams University

Enrollment

180 participants

Start Date

Apr 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria2

  • 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 Criteria3

  • 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.
  • \-

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Interventions

DRUGlactobacillus LS

Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients


Locations(1)

AinShams university hospitals

Cairo, Abbassia, Egypt

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NCT06936137