Antibiotic-associated DiarrheaPAADINCT03256708
Prevention of Antibiotic-Associated Diarrhoea With Prolardii
A study testing Prolardii in people with Antibiotic-associated Diarrhea, run by Therabel Pharma SA/NV at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- Prolardii
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Oct 2017to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 (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.
- Conditions
- Antibiotic-associated Diarrhea
- Being tested
- Prolardii, Placebo
- Keywords
- antibiotic-associated diarrhea, probiotic, prebiotic, placebo, synbiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlardiiDietary supplement
Prolardii: 2 capsules per day for 12 to 15 days
PlaceboDietary supplement
Inactive ingredients
| Study group | Role | What they receive |
|---|---|---|
| Prolardii | Experimental | 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. Receives: Dietary Supplement: Prolardii |
| Placebo | Placebo comparator | Inactive ingredients Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of antibiotic-associated diarrhea
Percentage of patients presenting an acute antibiotic-associated diarrhea
Measured: Antibiotic treatment duration (7 to 10 days) + 5 days
Secondary outcomes (5)
Duration of diarrhea
Number of days of diarrhea
Measured: Antibiotic treatment duration (7 to 10 days) + 5 days
Number of bowel movements
Number of defecations
Measured: 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)
Measured: Antibiotic treatment duration (7 to 10 days) + 5 days
Quality of life of the patients
Quality of life score
Measured: Antibiotic treatment duration (7 to 10 days) + 5 days
Safety of the study treatment
Percentage of patients with adverse events
Measured: Antibiotic treatment duration (7 to 10 days) + 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start19 Oct 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind parallel placebo-controlled randomized study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therabel Pharma SA/NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ECSOR
- Responsible party
- Sponsor
- Investigators
- Nicolas Foucart, Study director, Marketing Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256708
- Sponsor's protocol ID
- THE-2017-001
- Acronym
- PAADI
- Status last verified
- Apr 2018
- First submitted
- 18 Aug 2017
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomised Placebo-controlled Study of Prolardii Gastro-resistant (GR) Caps in the Prevention and Treatment of Antibiotic-associated Diarrhoea.
- ClinicalTrials.gov ID
- NCT03256708
- Acronym / sponsor ID
- PAADI / THE-2017-001
- Conditions
- Antibiotic-associated Diarrhea
- Keywords
- antibiotic-associated diarrhea, probiotic, prebiotic, placebo, synbiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Therabel Pharma SA/NVIndustry (pharma, biotech, devices)
- Collaborators
- ECSOR
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind parallel placebo-controlled randomized study
| Arm | Type | Receives |
|---|---|---|
| Prolardii | Experimental | Dietary Supplement: ProlardiiProlardii 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboInactive ingredients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProlardiiProlardii: 2 capsules per day for 12 to 15 days | Dietary supplement | Prolardii |
| PlaceboInactive ingredients | Dietary supplement | Placebo |
Primary outcome
Prevention of antibiotic-associated diarrhea
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Percentage of patients presenting an acute antibiotic-associated diarrhea
5 secondary outcomes
Duration of diarrhea
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Number of bowel movements
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Tolerability of the study treatment
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Quality of life of the patients
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Safety of the study treatment
Time frame: Antibiotic treatment duration (7 to 10 days) + 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Foucart study director
Marketing Manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolardii in people with Antibiotic-associated Diarrhea, run by Therabel Pharma SA/NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of antibiotic-associated diarrhea (time frame: Antibiotic treatment duration (7 to 10 days) + 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.