CTRI/2021/08/035889尚未招募2 期
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 Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Willing and able to provide written informed consent prior to any study-related activities being performed.
- •2. Able and willing to comply with the protocol, including availability for all scheduled study visits.
- •3. Male and Female patients aged 18 to 65 years (both inclusive).
- •4. Patients diagnosed with
- •Ã¯â??§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 K59.03.
- •Ã¯â??§The constipation is accompanied with FGID symptoms as per Rome III criteria.
- •Ã¯â??§Are under treatment with constipation causing drugs for at least 3 months prior to screening.
- •5. 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:
- •Ã¯â??§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
- •Ã¯â??§Intrauterine device or intrauterine system
- •Ã¯â??§Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
- •Ã¯â??§Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient)
- •Ã¯â??§Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
- •Ã¯â??§Total abstinence, partial abstinence is not acceptable.
- •6. 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
- •1. Known hypersensitivity to contents of drug product or related class of drugs or to any of the excipients of the formulation.
- •2. Addicted alcoholics and/or drug abusers.
- •3. History or presence of coronary, renal, pulmonary and thyroid disease.
- •4. Active or a history of inflammatory bowel disease.
- •5. Has undergone any abdominal surgery, except for hernia repair or appendectomy.
- •6. Has had active treatment with prescription medication for any of the FGID symptoms within 4 weeks prior to screening.
- •7. Has been diagnosed with infectious gastroenteritis within 6 weeks prior to screening.
- •8. Has undergone treatment with probiotics within 6 weeks prior to screening.
- •9. Has used antibiotics within 14 days prior to screening.
- •10. Has a known diagnosis of gastroparesis.
- •11. Has used antipsychotic medications within 3 months prior to screening.
- •12. Has used systemic steroids within 1 month prior to screening.
- •13. Has suffered from a major psychiatric disorder within the past 2 years from screening.
- •14. AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count <95,000/microleter.
- •15. Difficulty in swallowing and retaining oral formulation.
- •16. Known HBsAg positive, Anti HCV and HIV positive.
- •17. Patient has condition or is in a situation which, in the investigatorââ?¬•s opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patientââ?¬•s participation in the study.
- •18. Participation in any other clinical study within 30 days before the first dose of Investigational Product.
- •19. Pregnant or Lactating female patient.
研究者
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