Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03256708
Status:
UNKNOWN
Last Update Posted:
2018-04-03
First Post:
2017-08-18
Brief Title:
Prevention of Antibiotic-Associated Diarrhoea With Prolardii
Sponsor:
Therabel Pharma SANV
Organization:
Therabel Pharma SANV
Study Overview
Official Title:
Double-blind Randomised Placebo-controlled Study of Prolardii Gastro-resistant GR Caps in the Prevention and Treatment of Antibiotic-associated Diarrhoea
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAADI
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 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
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
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 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 11 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 paincramps 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 11 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
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 11 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 paincramps 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None