Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

Danisco

Status and phase: Completed; Phase 2

Conditions: Antibiotic Therapy

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01667653

11PDHD

Details and patient eligibility

About

This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.

Enrollment: 80 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female aged 18 to 50 years.
• Healthy as determined by laboratory results, medical history and physical exam
• Willing to give voluntary, written, informed consent to participate in the study

Exclusion criteria

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
• Body mass index ≥ 30 kg/m2
• Average number of formed bowel movements > 3 per day or < 3 per week
• Smokers
• Participation in a clinical research trial within 30 days prior to randomization
• Use of antibiotics within 60 days prior to randomization.
• Habitual use of pro- and/or prebiotic products.
• Follows a vegetarian or vegan diet
• Unstable medical conditions
• Any evidence of acute or chronic gastrointestinal disorder
• Alcohol use > 2 standard alcoholic drinks per day and/or alcohol or drug abuse within past year
• Allergy or sensitivity to test product ingredients or antibiotic
• Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Augmentin/Probiotic

Experimental group

Description:

Participants are provided in double blinded fashion probiotic to take with antibiotics

Treatment:

Dietary Supplement: Probiotic

Augmentin/placebo

Experimental group

Description:

Participants are provided in double blinded fashion placebo to take with antibiotics

Treatment:

Dietary Supplement: Placebo