: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
NCT ID: NCT06936137
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2025-04-20
2026-12-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus
lactobacillus LS
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients
Participants will be advised to be adherent to their standard treatment and followed up regularly.
No interventions assigned to this group
Interventions
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lactobacillus LS
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients
Eligibility Criteria
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Inclusion Criteria
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
2. Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases.
\-
18 Years
45 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Locations
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AinShams university hospitals
Cairo, Abbassia, Egypt
Countries
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Central Contacts
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Other Identifiers
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MD343/2024
Identifier Type: -
Identifier Source: org_study_id
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