Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic Treatment

KGK Science

Status and phase

Completed

Phase 2

Phase 1

Conditions

Antibiotic Associated Diarrhea

Treatments

Dietary Supplement: Lacidofil® STRONG

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01941160

13LAHL

Details and patient eligibility

About

The objectives of this study are to evaluate stool consistency and stool frequency during and up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg BID.

Full description

It is hypothesized that the proportion of subjects having a diarrhea-like defecation, defined as a stool frequency ≥ 3 per day and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days will be lower in the group receiving Lacidofil® STRONG compared to the group receiving placebo and therefore mean Bristol Stool Scores will be lower in subjects receiving Lacidofil® STRONG compared to those receiving placebo.

Enrollment

160 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female aged 18 to 50 years inclusive
Body mass index 18.0 - 29.9 kg/m2
Healthy as determined by laboratory results, medical history and physical exam
Agrees to comply with study procedures
Agrees not to change current dietary habits (with the exception of avoiding pro- and prebiotics) and activity/training levels during the course of the study
Has given 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
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. Subjects must not consume foods or supplements containing added pro- and/or prebiotics within 3 weeks prior to randomization and during the course of the study
Use of laxatives, enemas or suppositories 1 week prior to randomization and for the duration of the study
Follows a vegetarian or vegan diet
Unstable medical conditions, as determined by the Qualified Investigator
History of chronic gastrointestinal disorders including irritable bowel syndrome; chronic constipation; chronic diarrhea; dyspepsia; gastroesophageal reflux disease; diverticulitis; colitis; Crohn's disease; or any other malabsorption or gastrointestinal disorder
Subjects with an immuno-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
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 Amoxicillin/Clavulanic Acid
Individuals who are cognitively impaired and/or who are unable to give informed consent
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