Providac techsules for prevention of Antibiotic-Associated Diarrhea
- Conditions
- Antibiotic-Associated DiarrheaOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12611000384954
- Lead Sponsor
- Zydus Alidac,Cadila Healthcare Limited,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
adult patients who received oral systemic oral antibiotic therapy [cefadroxil or amoxicillin] for at least 5 days
1.Subjects who had completed a course of systemic antibiotic in the last 7 days prior to screening.
2.Severe infection requiring hospitalization or parenteral antibiotic therapy
3.Pregnancy and/or lactation.
4.Patients who were debilitated or seriously ill or immunocompromised
5.Patients with acute infective diarrhea, septicaemia, endocarditis, uncontrolled diabetes or any malignancy
6.Patients with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohn’s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhea and functional constipation.
7.Patients with hepatic and / or renal insufficiency.
8.Patients with unstable hyperthyroidism or hypothyroidism.
9.Patients who have undergone ileostomy, jejunostomy or colostomy.
10.Patient undergoing active radiotherapy or chemotherapy.
11.Current use of any drugs or treatments which is supposed to decrease the gastrointestinal motility or any other concomitant anti-diarrheal medication.
12.Patients with hypersensitivity to any ingredient in the formulation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method