A Clinical Study to Evaluate the Effectiveness and Safety of Bacillus coagulans LBSC in Patients with Irritable Bowel Syndrome.
- Conditions
- Health Condition 1: null- Irritable Bowel Syndrome
- Registration Number
- CTRI/2018/02/011654
- Lead Sponsor
- Advanced Enzymes Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Male and females aged 18 and 65 yrs. completed years (both inclusive) with diagnosis of IBS as per Rome IV criteria with following symptoms for more than 3 months
2. Abdominal discomfort such as mild pain, cramping, bloating,
3. Altered bowel habit indicated by frequent diarrhea or constipation
4. Functional dyspepsia
3. Written informed consent by study participants
1. On antibiotics or laxatives within the preceding 6 weeks.
2. Presence of inflammatory bowel disease
3. Presence of acute GI tract infection
4. Presence of fever, abdominal mass, signs of bowel obstruction
5. History of colon cancer or diverticulitis
6. Infection by human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus
7. Patients with celiac disease defined by biopsy of the duodenal mucosa.
8. History of scleroderma and gastroparesis
9. Hypothyroidism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assessment of change in Gastrointestinal symptoms frequency assessment using DSFQ on 5-point Likert scale. <br/ ><br>2. Assessment of change in gastrointestinal symptoms severity using IBS-SSS. <br/ ><br>3. Assessment of change in stool consistency using Bristol stool chart <br/ ><br>Timepoint: Screening to End of Treatment
- Secondary Outcome Measures
Name Time Method Assessment of safety of investigational product: <br/ ><br>1. Adverse event <br/ ><br>2. Physical examination <br/ ><br>3. Biomarker of systemic safety <br/ ><br>4. Hematological â?? CBC <br/ ><br>5. Hepatic - SGOT, SGPT <br/ ><br>6. Renal - serum creatinine <br/ ><br>7. Quality of life questionnaire by VAS assessments <br/ ><br>Timepoint: Screening to End of Treatment