: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
Recruiting
Phase 3
Interventional Study
Antipsychotic Induced Weight Gain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 45
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 180 (estimated)
- Sponsor
- Ain Shams University · Other
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About This Trial
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 pat…
Trial Locations
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Eligibility Criteria
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 dura…
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