Prevention of Antibiotic-Associated Diarrhoea With Prolardii

NCT03256708 | Unknown

• 1 other identifier: THE-2017-001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic-associated Diarrhea

Keywords

antibiotic-associated diarrhea; probiotic; prebiotic; placebo; synbiotic

Outcome Measures

Primary Outcomes (1)

• Prevention of antibiotic-associated diarrhea

  Percentage of patients presenting an acute antibiotic-associated diarrhea

  Antibiotic treatment duration (7 to 10 days) + 5 days

Secondary Outcomes (5)

• Duration of diarrhea

  Antibiotic treatment duration (7 to 10 days) + 5 days

• Number of bowel movements

  Antibiotic treatment duration (7 to 10 days) + 5 days

• Tolerability of the study treatment

  Antibiotic treatment duration (7 to 10 days) + 5 days

• Quality of life of the patients

  Antibiotic treatment duration (7 to 10 days) + 5 days

• Safety of the study treatment

  Antibiotic treatment duration (7 to 10 days) + 5 days

Study Arms (2)

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.

Dietary Supplement: Prolardii

Placebo

PLACEBO COMPARATOR

Inactive ingredients

Dietary Supplement: Placebo

Interventions

Prolardii DIETARY_SUPPLEMENT

Prolardii: 2 capsules per day for 12 to 15 days

Prolardii

Placebo DIETARY_SUPPLEMENT

Inactive ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Therabel Pharma SA/NV: lead
• ECSOR: collaborator

Study Sites (1)

ResearchLink

Linkebeek, Belgium

Location

Study Officials

• Nicolas Foucart

  Marketing Manager

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind parallel placebo-controlled randomized study

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 22, 2017
• Study Start: October 19, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)