Status:
UNKNOWN
Prevention of Antibiotic-Associated Diarrhoea With Prolardii
Lead Sponsor:
Therabel Pharma SA/NV
Collaborating Sponsors:
ECSOR
Conditions:
Antibiotic-associated Diarrhea
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Prolardii contains intestinal bacteria, a yeast, a fructo-oligosaccharide and a plant extract that can contribute to the intestinal comfort. This product could prevent the diarrhea which sometimes occ...
Detailed Description
Prolardii is a synbiotic (prebiotic and probiotic) formulation including 4 strains of living lyophilized lactic bacteria (Lactobacillus rhamnosus GG, Bifidobacterium lactis B94, Lactobacillus casei 57...
Eligibility Criteria
Inclusion
- Written informed consent
- Male or female patient
- Patient aged 18 to 65 years-old
- Patient being prescribed broad spectrum antibiotics for a minimum period of 7 days and a maximum period of 10 days. Broad spectrum antibiotics are aminopenicillins (amoxicillin with or without clavulanic acid, ampicillin), cephalosporins (cefadroxil, cephalexin, cefazolin, cefuroxime, cefotaxime, ceftazidime, ceftriaxone and ceftaroline), fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin), tetracyclines (doxycycline, minocycline), nitrofurans (nitrofurantoin) and/or antibacterial sulfonamides (co-trimoxazol).
- Patient who the investigator believes that they can and will comply with the requirements of the protocol.
Exclusion
- Patient treated with antibiotics within 3 months before inclusion in the study
- Pregnant or lactating woman
- Woman wishing to be pregnant
- Immunosuppressed subject
- Subject having a central venous catheter
- History of chronic diarrhoea
- History of irritable bowel syndrome
- History of Crohn's disease
- History of ulcerative colitis
- History of chronic constipation and/or chronic use of laxatives
- Patient with a clinically-active malignancy.
- Patient who participated in a clinical study in the previous three months
- History of psychological disorder, mental dysfunction, alcohol or drug abuse or any other factor which might interfere with the ability to cooperate in the study.
- Patient who is not sufficiently motivated to engage on a follow-up period of approximately 1.5 month, unable to complete the patient diary, or likely to travel or to move before the end of the study
- Intolerance to lactose
- Difficulty or inability to swallow '00' size capsules
- Allergy to one or several ingredients of Prolardii® GR Caps and in particular to yeasts.
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03256708
Start Date
October 19 2017
End Date
September 1 2018
Last Update
April 3 2018
Active Locations (1)
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1
ResearchLink
Linkebeek, Belgium