: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED 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 patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Rehab Abdelmaksoud
- Phone Number: 02 01158336110
- Email: rehab.abdelmaksoud@med.asu.edu.eg
Study Locations
-
-
Abbassia
-
Cairo, Abbassia, Egypt, 00202
- Recruiting
- Ainshams University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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:
- 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.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus
|
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients
|
|
No Intervention: Participants will be advised to be adherent to their standard treatment and followed up regularly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD343/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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