Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: BacilluscoagulansLBSC: Bacillus coagulans LBSC 2 Billion spores / gram per sachet
Dose: 2 Billion spores / gram per sachet
Frequency: Thrice a day (morning, afternoon and evening)
Rout
Sponsors
Advanced Enzyme Technologies Ltd
Eligibility
Inclusion 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 ïâ??§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. ïâ??§The constipation is accompanied with FGID symptoms as per Rome III criteria. ïâ??§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: ïâ??§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 ïâ??§Intrauterine device or intrauterine system ïâ??§Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) ïâ??§Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) ïâ??§Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation ïâ??§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).
Exclusion criteria
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. 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in constipation symptoms based on occurrence of constipation in % 2.Change in constipation symptoms based on ââ?¬Â¢Degree of constipation on 4-point likert scale ââ?¬Â¢Degree of stool consistency ââ?¬Â¢Occurrence of hard stools in % ââ?¬Â¢Degree of stool expulsion on 3-point scale ââ?¬Â¢Defecation frequency (Times/day/person and times/week/person) ââ?¬Â¢Change in Constipation Scoring System ââ?¬Â¢Change in FGIDs symptoms based on 4-point Likert scaleTimepoint: 1.From baseline Day 14 to Day 49 2.From baseline Day 14 to Day 49 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in vital signs 2.Mean change in Laboratory parameters 3.Change in pharmacological parameter evaluated as a mean serum concentration of drug causing constipation 4.Improvement in Health Related Quality of Life (HRQoLs) Questionnaires ââ?¬Â¢Patient Health Questionnaire 15 item Somatic Symptom Severity Scale (PHQ-15) ââ?¬Â¢Medical Outcomes Study: 20 Item Short Form Survey (SF-20)Timepoint: 1.From baseline Day 14 to Day 49 2.From baseline Day 1 to Day 49 3.From baseline Day 14 to Day 49 4.From baseline Day 14 to Day 49;Safety Outcome:Number and types of adverse events (AEs) and serious adverse events (SAEs)Timepoint: Post randomization to Day 60 | — |
Countries
India
Contacts
Public ContactMr Nimesh Parekh
COD Research Pvt Ltd
Outcome results
None listed