NCT06936137招募中3 期
: EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.
研究概览
简要总结
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:
- To determine the effect of probiotic supplementation on the psychological state of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult schizophrenia patients (18-45 years) on second generation antipsychotics Stable patients with a total positive and negative syndrome scale (PANSS) score of ≤
- •With more than 10% weight gain after taking atypical antipsychotics for at least 3 months with treatment duration not more than two years.
排除标准
- •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.
研究组 & 干预措施
Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus
Experimental
干预措施: lactobacillus LS (Drug)
结局指标
主要结局
To determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications.
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
A Probiotic Strategy for Antipsychotic-induced Metabolic DysfunctionPsychosisNCT06729671University College Cork70
招募中
不适用
Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe PneumoniaProbioticsPneumoniaNCT06323642Shaheed Zulfiqar Ali Bhutto Medical University60
招募中
4 期
To study the effects of probiotics plus prebiotics on antipsychotic induced weight gain: a randomized controlled trialCTRI/2023/08/056889Government Medical College Patiala Punjab
招募中
不适用
To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast CancerBreast CancerNCT06039644GenMont Biotech Incorporation100
已完成
1 期
Effect of Probiotic Supplement on Improvement of Depressive Symptoms in Patients With Substance-Induced Depressive DisorderNCT06790823Shiraz University of Medical Sciences40