A prospective, interventional, randomized, double-blind, parallel, multi-arm, controlled clinical study to evaluate the efficacy and safety of Bacillus coagulans LBSC in the treatment of drug-induced constipation associated with functional gastrointestinal disorder (FGID) symptoms

Advanced Enzyme Technologies Ltd5 个研究点分布在 1 个国家目标入组 168 人开始时间: 2021年8月30日最近更新: 2021年12月30日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 168
试验地点: 5
主要终点: 1.Change in constipation symptoms based on

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The current study is designed as a prospective, interventional, randomized, double-blind, parallel, multi-arm, controlled clinical study. This study involves a screening phase, run-in phase, randomization and treatment phase, and follow-up phase as mentioned below:

1.Screening phase (Visit 1): Day -14 to -1

2.Baseline assessment, enrolment and run-in period initiation (Treatment continuation with drug inducing constipation; Visit 2): Day 1

3.Run-in period completion, baseline assessment and day of randomization (Visit 3): Day 14 Â±1 day

4.Initiation of treatment with test product or its matching placebo: Day 15

Interim follow up 1 (Visit 4): Day 22 Â±2 days
Interim follow up 2 (Visit 5): Day 36 Â±2 days
End of treatment (Visit 6): Day 50 Â±2 days
End of study (telephonic safety call): Day 60 Â±2 days
Treatment phase with IPs: 35 Days

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Willing and able to provide written informed consent prior to any study-related activities being performed.
•Able and willing to comply with the protocol, including availability for all scheduled study visits.
•Male and Female patients aged 18 to 65 years (both inclusive).
•Patients diagnosed with ï‚§Chronic functional constipation induced by selected classes of drugs followed by Rome IV criteria (refer Appendix 1) [following the International Classification of Diseases, 10th Ed. (ICD-10-CM) Medical Diagnosis Code K59.
•ï‚§The constipation is accompanied with FGID symptoms as per Rome III criteria.
•ï‚§Are under treatment with constipation causing drugs for at least 3 months prior to screening.
•Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception.
•Acceptable methods of contraception are: ï‚§Oral or parenteral (injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication ï‚§Intrauterine device or intrauterine system ï‚§Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) ï‚§Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) ï‚§Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation ï‚§Total abstinence, partial abstinence is not acceptable.
•Female patients with negative urine pregnancy test (only for female who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation).

排除标准

•Known hypersensitivity to contents of drug product or related class of drugs or to any of the excipients of the formulation.
•Addicted alcoholics and/or drug abusers.
•History or presence of coronary, renal, pulmonary and thyroid disease.
•Active or a history of inflammatory bowel disease.
•Has undergone any abdominal surgery, except for hernia repair or appendectomy.
•Has had active treatment with prescription medication for any of the FGID symptoms within 4 weeks prior to screening.
•Has been diagnosed with infectious gastroenteritis within 6 weeks prior to screening.
•Has undergone treatment with probiotics within 6 weeks prior to screening.
•Has used antibiotics within 14 days prior to screening.
•Has used antipsychotic medications within 3 months prior to screening.
•Has used systemic steroids within 1 month prior to screening.
•Has suffered from a major psychiatric disorder within the past 2 years from screening.
•AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count <95,000/microleter.
•Difficulty in swallowing and retaining oral formulation.
•Known HBsAg positive, Anti HCV and HIV positive.
•Patient has condition or is in a situation which, in the investigatorâ€™s opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patientâ€™s participation in the study.
•Participation in any other clinical study within 30 days before the first dose of Investigational Product.
•Pregnant or Lactating female patient.