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

ConditionAntipsychotic Induced Weight Gain

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-45

SponsorAin Shams University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult schizophrenia patients (18-45 years) on second generation antipsychotics Stable patients with a total positive and negative syndrome scale (PANSS) score of ≤60.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

lactobacillus LS
Drug
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillusExperimental treatment 1 intervention

Group B: Participants will be advised to be adherent to their standard treatment and followed up regularly.No intervention 0 interventions

Trial outcomes

Primary outcomes

To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

Apply now