None listed
Conditions
Interventions
Intervention1: Bacillus Subtilis PB6: PB6 8E+9 spores arm: 2 PB6 4E+9 spores capsules, three times daily
Intervention2: Bacillus Subtilis PB6: PB6 2E+9 spores arm: 2 PB6 1E+9 spores capsules, three ti
Sponsors
Kemin Pharma
a division of Kemin Industries South Asia Pvt. Ltd.
The Trapezium, No 39, Nelson Manickam Road,
Chennai-600029, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Must sign and date written informed consent prior to any study-related procedures and, in the opinion of the investigator, be willing and likely to comply with all requirements of the study 2. Male or non-pregnant female patients 18-65 years of age, inclusive 3. A history of UC for at least 6 months prior to time of screening 4. All subjects must have clinical and endoscopic confirmed diagnosis of active mild to moderate UC with disease extension beyond the rectum (>12 cm from the ano-rectal junction) ?confirmed by obligatory colonoscopy/endoscopy at screening: full report to be available and score equal to or greater than 2 (at least moderate friability) ?Ulcerative Colitis Disease Activity Index [UCDAI] of 5-10, inclusive, as assessed on screening (based on retrospective recall by the subject over the previous 3 days) and confirmed after 7 days of baseline observation, before inclusion in the randomization procedure, and not improving more than 2 score points during this run-in period 5. Duration of current relapse < 6 weeks from screening (according to patient) 6. Oral mesalazine/sulfasalazine maintenance therapy (eqaul to or less than 2 g/day) for no less than 30 days prior to screening. 7. Females of childbearing potential require a negative urine pregnancy test and must agree to abstinence or to use prescription contraceptives and to use a barrier contraceptive device along with a spermicidal product for the duration of the study. Subjects who are surgically sterile, menopausal or using contraceptive implants prior to the study enrolment are not required to utilize dual contraceptive techniques 8. Otherwise in general good health as judged by the investigator
Exclusion criteria
Exclusion criteria: 1. Proctitis (equal to or less than 12 cm from the ano-rectal junction) 2. Indeterminate colitis 3. Crohn's disease 4. Previous colonic surgery 5. Severe or fulminant UC [UCDAI >10] or requiring hospitalization 6. Evidence of other forms of inflammatory bowel disease 7. Subjects with a new diagnosis of UC 8. Subjects who altered their mesalazine/sulfasalazine dosage (dose regimen or dose) in the previous 2 weeks before screening 9. Subjects with a positive stool culture for any enteric pathogens that is clinically significant, pathogenic ova or parasites, or a positive enzyme immunoassay (EIA) that is subsequently confirmed by a positive cytotoxin assay for C. difficile toxin 10. Subjects who have used the following medications within the specified period -Loperamide and other anti-diarrheal agents, probiotics, antibiotics: 1 week wash-out during baseline period -Non steroidal anti-inflammatory drugs (NSAIDs) and Cyclo-oxygenase-2 (COX-2) inhibitors, within 14 days from screening -Oral and injectable steroids, within 30 days from screening -Rectally administered mesalazine/sulfasalazine or other 5-ASAs or steroids, within 7 days from screening. Topical dermatological corticosteroids are not excluded -Antivirals or antifungals within 30 days -Immunomodulating/suppressing drugs or biologicals (including anti TNF-&#945;, cyclosporine, thalidomide, methotrexate) within 2 month -Sulfasalazine or mesalazine at higher dose than for maintenance treatment (higher than 2g/day) 11. Failing to respond to steroids within the previous year prior to screening 12. Subjects who have any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the subject?s involvement in the study or overall interpretation of the data, such as mental/emotional disorder, dysplasia or cancer, HIV, uncontrolled hematologic, renal, hepatic, metabolic pulmonary or cardiovascular disease, active alcohol or drug abuse 13. Needing enemas to treat their disease or to maintain remission 14. Subjects with abnormal laboratory values at admission which are clinically significant by the investigator (outlier values outside the normal values are allowed and to be marked as ?NCS? if considered Non-Clinically Significant (NCS) by the investigator based on the nature of the disease, quite some UC patients having an aberrant immune response and abnormal laboratory values due to the impaired absorption, and blood loss) 15. Subjects whose UCDAI score decreases &#8805;2 during the 7-day run-in period 16. Allergy to aspirin or salicylate derivatives 17. Subject with a history of drug allergy in general or hypersensitivity to probiotics 18. Participation in another clinical study within the 3 months prior to screening 19. Inability to comply with the protocol requirements or to fill in the diary cards 20. Pregnancy or breast-feeding women or women of child-bearing potential not agreeing to birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in remission i.e. UCDAI score equal to or less than 2 with no individual subscore >1Timepoint: At endpoint for ITT population and week 8 (visit 3) for PP population | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Specific QoL IBDQ (patient rating): change in the scores versus baselineTimepoint: Week 4 and 8;Laboratory values (hematology, biochemistry) Timepoint: At start, week 4 and week 8;Pilot HNPQ (patient rating) plus potentially objective parameters (maintenance of weight, hemoglobin)Timepoint: Week 4 and 8;Proportion of patients in Colonoscopic/endoscopic remission: defined as UCDAI endoscopy score of &#8804;1Timepoint: Week 8 and end of treatment;Proportion of patients in Remission: UCDAI score &#8804;1 [stool frequency normal, rectal bleeding absent and a colonoscopy/endoscopy score reduction of 1 point or more from baseline]Timepoint: Week 8 and end of treatment;Proportion of patients in: Clinical remission (cessation of bleeding and normal stool frequency, scores of 0 for both symptoms)Timepoint: Week 2, 4 and 8;Proportion of patients in: Complete remission: UCDAI score = 0 [=normal stool frequency, no rectal bleeding and a normal or quiescent appearance of mucosa on colonoscopy/endoscopy]Timepoint: Week 8 and end of treatment;Safety: Tolerability scoreTimepoint: 2, 4 and 8 weeks ;UCDAI Score -Change from baseline (week 0, visit 0)Timepoint: Week 8;UCDAI Score -Change from baseline (week 0, visit 0) in partial UCDAI scoreTimepoint: Week 2, 4 and 8;Vital signs: weight, pulse, blood pressure, respiratory rate and oral temperature at every visit Timepoint: Every visit;Clinical Response - proportion of patients with: Clinical improvement, defined as partial UCDAI score decreasing &#8805; 2 from baseline [not including the endoscopy/colonoscopy, but including the 3 other scores (stools, bleeding, Physicians rating of disease activity)] (parameter found predictive for patient-reported improvement of disease activity) Timepoint: Week 2, 4 and 8;Clinical Response - proportion of patients with: -Overall improvement, defined as a decrease in UCDAI &#8805;3 from baseline [stool frequency, rectal bleeding, Physicians rating of disease activity and co | — |
Countries
India
Contacts
Public ContactAhmed Meeran
Senior Manager-Medical Affairs
Outcome results
None listed