None listed
Conditions
Interventions
Intervention1: Probiotic and lactulose suspension: Each 15 ml suspension contains:
Bacillus coagulans Unique IS2 - 2 billion cfu and Lactulose â??10 gms
Sponsors
Unique Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subject aged between 18 and 65 years old (both inclusive). 2. Has diagnosis of functional constipation according to Rome Criteria III. 3. Willing to give IEC approved informed consent. 4. Willing to abide by the study requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects who have undergone major abdominal surgery. 2. Subjects with a documented history of slow colonic transit. 3. Presence of any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance; medical or psychiatric illness 4. Subjects with clinical features suggestive of alarming symptoms (rectal bleeding, weight loss, etc.) 5. Family history of peptic ulcer, colorectal cancer, or IBD 6. Abnormal laboratory data or thyroid function. 7. Participated in any clinical trial in the past 90 days. 8. Have received any probiotic formulation in the past 30 days. 9. Known or expected hypersensitivity to any of the active substances or excipients. 10. Subject is pregnant or lactating. 11. Subject allergic or atopic to any of the ingredients of the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success (defined as 3 or more spontaneous stools per week)Timepoint: Visit 1- Treatment initiation ( Day 1) Visit 2- (Day 8 ± 2) Visit 3- (Day 15 ± 2) Visit 4- (Day 29 ± 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline at EOS in: a. Stool frequency b. Stool consistency (as assessed by Bristol stool form scale). c. Difficulty degree of defecation-sensation of incomplete evacuation (Constipation Scoring System [CSS] scale). d. Defecation pain (Constipation Scoring System [CSS] scale). e. Abdominal Pain (Constipation Scoring System [CSS] scale). Timepoint: Visit 1- Treatment initiation ( Day 1) Visit 2- (Day 8 ± 2) Visit 3- (Day 15 ± 2) Visit 4- (Day 29 ± 2) | — |
Countries
India
Contacts
Public ContactDr N Jayanthi
Adichunchanagiri Hospital And Research Center
Outcome results
None listed