An interventional study of Prolardii and Placebo in Antibiotic-associated Diarrhea, sponsored by Therabel Pharma SA/NV. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-03.
Sponsored by Therabel Pharma SA/NV · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Prolardii GR Caps includes 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.
Dietary Supplement: Prolardii
Inactive ingredients
Dietary Supplement: Placebo
Prolardii: 2 capsules per day for 12 to 15 days
Inactive ingredients
Prevention of antibiotic-associated diarrhea
Percentage of patients presenting an acute antibiotic-associated diarrhea
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Duration of diarrhea
Number of days of diarrhea
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Number of bowel movements
Number of defecations
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Tolerability of the study treatment
Percentage of patients showing solicited symptoms (flatulence, bloating, abdominal pain/cramps, nausea and/or vomiting)
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Quality of life of the patients
Quality of life score
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Safety of the study treatment
Percentage of patients with adverse events
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Plan to share: No
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Therabel Pharma SA/NV