CTRI/2021/08/035889
Not yet recruiting
Phase 2
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 sites0 target enrollmentTBD
ConditionsHealth Condition 1: K590- Constipation
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: K590- Constipation
- Sponsor
- Advanced Enzyme Technologies Ltd
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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