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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06936137
Enrollment
180
Registered
2025-04-20
Start date
2025-04-20
Completion date
2026-12-20
Last updated
2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antipsychotic Induced Weight Gain

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 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.

Interventions

DRUGlactobacillus LS

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frame
To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.12 weeks

Countries

Egypt

Contacts

Primary ContactRehab Abdelmaksoud
rehab.abdelmaksoud@med.asu.edu.eg02 01158336110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026