Efficacy and Safety of Synbiotic Formulation in Human Subjects
- Conditions
- Health Condition 1: null- Constipation
- Registration Number
- CTRI/2014/05/004587
- Lead Sponsor
- ITC Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
1. Males or females aged from 18 to 65 years, both inclusive.
2. Subjects with active symptoms of abdominal pain or discomfort.
3. IBS diagnosed by Rome III criteria:
4. Functional Constipation diagnosed by Rome III criteria:
5. Females of child-bearing potential should be willing to use adequate methods of contraception.
6. Subjects willing to provide a written and recorded informed consent
7. Subjects with no regular use of fibre supplementation (e.g. Fybogel, Lactulose) over the week prior to the screening visit.
1. Major gastrointestinal complication (e.g. Crohns disease, ulcer, cancer).
2. The subject has a serious, unstable medical condition, such as lung disease, uncontrolled blood pressure, uncontrolled thyroid function, a physical or medical disability or an advanced medical condition.
3. The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer).
4. The subject had previous significant gastric or intestinal surgery (except appendectomy and gall bladder surgery).
5. IBS subtype other than IBS associated with Constipation.
6. Diarrhoea (more than 3 bowel movements per day).
7. Consumption of probiotics or prebiotics within 2 weeks of randomization.
8. Antibiotic use within 4 weeks of randomization.
9. Laxative or other constipation medication use within 2 weeks of randomization.
10. Subjects on the ongoing therapies with the drugs known to effect gut motility (e.g. laxatives, prokinetics, etc).
11. Consumption of IBS medications, anti-depressants, pain reliever medications within ten days prior to treatment or during treatment.
12. Subject with eating disorder.
13. Known allergies to any substance in the study product, including lactose intolerance and galactosemia.
14. Pregnant or lactating women.
15. History of alcohol, drug, or medication abuse.
16. Participation in another study with any investigational product (IP) within 3 months of randomization.
17. Subject with any condition that might interfere with the conduct of the study as per Investigators opinion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method