Providac techsules for prevention of Antibiotic-Associated Diarrhea

Randomized placebo-controlled, double blind, Multicentric Trial on Efficacy and Safety of Providac techsules (Lactobacillus acidophilus LA-5 and Bifidobacterium BB -12) for prevention of Antibiotic-Associated Diarrhea in Indian patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000384954

Enrollment

400

Registered

2011-04-13

Start date

2010-02-03

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Orally administered Providac capsules (Lactobacillus acidophilus LA5, 500 million Colony Forming Units & Bifidobacterium BB12, 500 million Colony Forming Units) twice daily or placebo treatment, taken twice daily (alongwith antibiotic therapy commencement) after food for 14 days and followed up during this period of 14 days (at day 7 and day 14 following study medication commencement). A special name assigned to specially designed capsules-Techsules. These are Technologically innovated capsule

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

adult patients who received oral systemic oral antibiotic therapy [cefadroxil or amoxicillin] for at least 5 days

Exclusion criteria

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.

Outcome results