Antibiotic associated diarrhea
Conditions
Interventions
Trade Name: Linex® forte
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lactobacillus acidophilus Bifidobacterium animalis subsp. lactis
Other descriptive name: liophilisated lactic acid ba
Sponsors
Lek Pharmaceuticals d.d.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between ?18 to 70; male or female 2. Subject has been prescribed antibiotic therapy for the duration of at least 7 days to 2 weeks at baseline visit (amoxicillin-clavulanate) 3. Willing to consult with study doctor before any new drug would be taken during the course of their participation 4. Willing not to consume any products containing probiotics during participation in the clinical trial (see Appendix 3) 5. Willing to complete diary card during participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hypersensitivity to any of the ingredients or excipients: anhydrous glucose, microcrystal cellulose, potato starch, inulin, oligofructose (glucose, fructose, saccharose), magnesium stearat, hypromellose, titanium dioxide (E171), yellow iron oxide (E172) 2. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorbtion or sucrase-isomaltase insufficiency 3. Allergy to milk proteins 4. Pregnancy or lactation 5. Females of child-bearing potential not using effective contraception, i.e. oral contraception/intrauterine device and/or condoms 6. Immunocompromised patients 7. Unwilling or incapable to give written informed consent or to comply with study directives 8. Patients with diarrhea on entry or within the preceding week 9. Patients with diagnosis of irritable bowel syndrom, Chron disease, bowel pathology that could result in diarrhea 10. Current use of medication is in accordance with the criteria listed in Section 3.4.1.3. (Prohibited medication: Butilscopolamine (Buscopan), metoklopramid (Reglan), domperidon (Tametil), bisakodil (Dulcolax, Novolax), lactulose (Lactecon, Portalac, Prorektal S), lactitol (Importal), glycerol (glycerin globulae)) 11. Use of antibiotic in the previous two weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • to demonstrate clinical efficacy of new Linex® Forte hard capsules in comparison with placebo regarding frequency of occurrence of diarrhea in treatment with antibiotics;Secondary Objective: • to determine the duration of diarrhea • to observe microflora change from beginning to the end of treatment • to determine efficacy in C. difficile diarrhea ;Primary end point(s): Primary endpoint of the trial is to evaluate clinical efficacy of Linex® Forte hard capsules (capsule contains not less than 2 x 109 CFU of lyophillisated lactic acid bacteria Lactobacillus acidophilus (LA-5) and Bifidobacterium animalis subsp. lactis (BB-12) in ratio 1:1) in comparison with placebo as frequency of occurrence of diarrhea in treatment with antibiotics. | — |
Countries
Slovenia
Outcome results
None listed