Efficacy and Safety of Sinquanon for Prevention of Antibiotic-associated Diarrhea in Adults (SPAADA)

Neopharm

Status: Completed

Conditions: Antibiotic-associated Diarrhea

Treatments: Dietary Supplement: Sinquanon; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05607056

SPAADA202211_001

2022-002817-40 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of a probiotic, SINQUANON, on the reduction of the occurrence of diarrhea associated with antibiotic use in adults.

Full description

The study aims to evaluate the efficacy of a specialized multi-strain probiotic, SINQUANON, on the reduction of the incidence of antibiotic-associated diarrhea in adults and to demonstrate the benefit of administering the specialized multi-strain probiotic as a routine add-on to antibiotic therapy on prevention of antibiotic-associated diarrhea in adults who take antibiotics in the outpatient setting.

Enrollment: 565 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subject aged 18 to 60 years.

• The subject has given written informed consent after being provided orally with information about the study objective and design, including the administration regimen of the studied probiotic and the study procedures, the available safety data, as well as the rights and obligations of a participant.

• The subject initiates oral antibiotic treatment in the ambulatory setting.

• Acceptable antibiotic therapy:

  • Broad-spectrum penicillins
  • Cephalosporins
  • Quinolones
  • Tetracyclines

Sequential administration of two antibiotics from the allowed groups is permitted, if the total duration of the antibiotic treatment does not exceed 10 days.

• Planned duration of the antibiotic treatment of 5 to 10 days.
• Body mass index (BMI) of 18.0 to 29.9 kg/m2
• In the opinion of the Investigator, the subject can adhere to the visit schedule, to be compliant with the trial treatment regimen and to complete the study.
• The patient has a smartphone and can use it.

Exclusion criteria

• Antibiotics use within 60 days prior to randomization.
• Daily consumption of probiotics, yogurt with probiotics and inability to stop this consumption.
• Use of antidiarrheal medications, laxatives, enemas, or suppositories within 1 week prior to randomization and for the duration of the trial.
• An episode of diarrhea within 30 days before screening, defined as ≥3 loose or liquid stools over 24 hours, regardless of the cause of the diarrhea.
• Acute or chronic constipation - average number of formed stools <3 per week.
• Allergy or hypersensitivity to any of the ingredients of the trial product.
• Allergy or hypersensitivity to the antibiotic prescribed on Day 1.
• Prior documented infection with Clostridioides difficile ≤3 months before screening.
• History of chronic gastrointestinal conditions, including irritable bowel syndrome, chronic constipation, chronic diarrhea, dyspepsia, gastroesophageal reflux disease, diverticulitis, ulcerative colitis, Crohn's disease or any other abnormality in the absorption or gastrointestinal dysfunction.
• Use of proton-pump inhibitors (PPIs) within 30 days prior to Day 1 and for the duration of the study.
• Surgery to the intestines, artificial heart valve, history of rheumatological heart disease or infectious endocarditis within one year prior to screening.
• Immunosuppressive therapy or any condition causing immunosuppression (including hematologic malignancies, AIDS, long-lasting corticosteroid treatment).
• Planned administration of antibiotics, different from those acceptable for the study.
• Patients in severe condition requiring urgent hospitalization or planned hospitalization during the study.
• Planned administration of antibiotics >10 days.
• BMI ≥ 30 kg/m2.
• Pregnant or lactating women; women who plan to get pregnant during the study.
• Drug abuse or alcohol within the past year.
• Unstable medical conditions, in the judgement of the Investigator.
• Eating disorders (for example, anorexia, bulimia).
• On a vegan diet.
• Participation in a clinical trial within 60 days prior to randomization.
• Inability to comply with the study protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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565 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

During the antibiotic dosing (from 5 to 10 days): 2 capsules once a day 2 hours before or 2 hours after antibiotic administration. 14 days following completion of antibiotic dosing: 1 capsule a day.

Treatment:

Dietary Supplement: Sinquanon

Placebo

Placebo Comparator group

Description:

During the antibiotic dosing (from 5 to 10 days): 2 capsules once a day 2 hours before or 2 hours after antibiotic administration. 14 days following completion of antibiotic dosing: 1 capsule a day.

Treatment:

Dietary Supplement: Placebo