: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)

Ain Shams University

Status and phase: Enrolling; Phase 3

Conditions: Antipsychotic Induced Weight Gain

Treatments: Drug: lactobacillus LS

Study type: Interventional

Funder types: Other

Identifiers

NCT06936137

MD343/2024

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

1. Taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks.

2. Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus

Experimental group

Treatment:

Drug: lactobacillus LS

Participants will be advised to be adherent to their standard treatment and followed up regularly.

No Intervention group