: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lactobacillus LS.
- Who it may be relevant to
- Registry conditions: Antipsychotic Induced Weight Gain. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug lactobacillus LS
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients
Primary outcome measures
- To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications. [Time frame: 12 weeks]
Eligibility criteria
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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- AinShams university hospitals — Cairo
Identifiers
NCT: NCT06936137 · MD343/2024