NCT06936137RecruitingPhase 3
: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.
Study Overview
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:
- To determine the effect of probiotic supplementation on the psychological state of patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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 ≤
- •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
- •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.
Arms & Interventions
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus
Experimental
Intervention: lactobacillus LS (Drug)
Outcomes
Primary Outcomes
To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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