To evaluate the safety and efficacy of LactoSpore® vs. Placebo in patients with diarrhea predominant Irritable Bowel Syndrome.
- Conditions
- Health Condition 1: null- Diarrhea predominant Irritable Bowel SyndromeHealth Condition 2: K580- Irritable bowel syndrome with diarrhea
- Registration Number
- CTRI/2014/03/004502
- Lead Sponsor
- Sabinsa Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1. Male or female subjects ranging in age from 18 to 55 years (both inclusive) diagnosed as having gastro intestinal disorders and based on the medical history record will be included in the study by the Investigator.
2. Fulfilling Rome III Diagnostic Criteria for Functional IBS (Functional Diarrhea) 16. Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
a) Recurrent abdominal pain or discomfort (uncomfortable sensation not described as pain) at least 3 days/month in the last 3 months associated with two or more of the following:
i. Improvement with defecation
ii. Onset associated with a change in frequency of stool
iii. Onset associated with a change in form (appearance) of stool
b) Recurrent feeling of bloating or visible distension at least 3 days/month in the last 3 months
c) Loose (mushy) or watery stools without pain occurring in at least 75% of stools
3. Willingness to follow the protocol requirement as evidenced by written, informed consent.
4. Willingness to complete subject diaries and respond to study questionnaires.
5. Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study.
6. Agree not to use any yogurt during the course of this study.
7. Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.
8. Subjectâ??s assurance that they have not taken antibiotics or other drugs whose primary site of action is in the GIT for a period up to 1 month prior to the start of the study.
1. Sufficient criteria for a diagnosis of functional dyspepsia or other functional GI disorder.
2. Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
3. Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, serum chemistry, urinalysis.
4. History or presence of significant alcoholism or drug abuse in the past one year.
5. Participation in a clinical study during the preceding 90 days.
6. History of malignancy or other serious disease.
7. Any contraindication to blood sampling.
8. Smoking or Consumption of tobacco products.
9. Blood or blood products donated in past 30 days prior to study supplement administration.
10. Female subjects on pregnancy and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method