Antibiotic-associated Diarrhea Clinical Trial
Official title:
Double-blind Randomised Placebo-controlled Study of Prolardii Gastro-resistant (GR) Caps in the Prevention and Treatment of Antibiotic-associated Diarrhoea.
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 occurs when the patient has to take antibiotics.
A total of 220 patients being prescribed antibiotics by general practitioners will be
included in the study and randomized into a Prolardii arm and a placebo arm.
The primary endpoint will be the overall frequency of diarrhea in the two treatment groups.
Acute diarrhea will be defined as the presence of three or more abnormally loose or watery
stools per day.
Prolardii is a synbiotic (prebiotic and probiotic) formulation including 4 strains of living
lyophilized lactic bacteria (Lactobacillus rhamnosus GG, Bifidobacterium lactis B94,
Lactobacillus casei 5773 and Lactobacillus acidophilus LA3), a yeast (Saccharomyces
boulardii), a fructo-oligosaccharide (Actilight) and a dry extract of Inula helenium, a plant
that can contribute to the intestinal comfort.
Taking into account the international literature, we made the assumption that the combination
of probiotics and prebiotics into the same synbiotic product could improve the prevention of
antibiotic-associated diarrhea and could also attenuate the intestinal symptoms related to
the use of antibiotics. According to our knowledge this association has never been tested in
a double-blind, randomised, placebo-controlled study.
The study will be double-blind, parallel-group, randomized, multicentre and
placebo-controlled. A total of 220 patients being prescribed broad-spectrum antibiotics by
general practitioners will be included in the study and randomized (1:1) into a Prolardii arm
(2 capsules per day for 12 to 15 days) and a placebo arm (2 capsules per day for 12 to 15
days). There will be two medical visits (baseline visit and end-of-treatment visit) and one
follow-up phone call (4 weeks after the end of treatment). During the treatment, the patients
will filled in a diary card on a daily basis. They will record the number of bowel movements,
the quality of the stools, the solicited symptoms (flatulence, bloating, abdominal
pain/cramps, nausea and vomiting), their quality of life and the use of concomitant
medications.
The data will be collected in an electronic case report form. The sample size calculation was
based on the following assumptions: an attack rate in the placebo group situated in a range
between 20% and 25%, an efficacy of Prolardii of about 60%, a randomization ratio 1:1 between
the placebo and the active treatment group, a power of 80% and a Type I error value of 5%.
Taking into account these assumptions a total of at least 30 diarrhoea cases should be
reached all together in the two treatment groups, in order to ensure a sufficient power.
The primary endpoint will be the overall frequency of diarrhea in the two treatment groups.
Acute diarrhea will be defined as the presence of three or more abnormally loose or watery
stools per day.
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