: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2025
CompletedFirst Posted
Study publicly available on registry
April 20, 2025
CompletedStudy Start
First participant enrolled
April 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2026
April 20, 2025
April 1, 2025
1.2 years
April 13, 2025
April 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.
12 weeks
Study Arms (2)
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus
EXPERIMENTALParticipants will be advised to be adherent to their standard treatment and followed up regularly.
NO INTERVENTIONInterventions
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AinShams university hospitals
Cairo, Abbassia, 00202, Egypt
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2025
First Posted
April 20, 2025
Study Start
April 20, 2025
Primary Completion (Estimated)
June 20, 2026
Study Completion (Estimated)
December 20, 2026
Last Updated
April 20, 2025
Record last verified: 2025-04