Phase
Condition
Lactose Intolerance
Colic
Gastroenteritis
Treatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female subjects over 18 years of age traveling to Mexico, Central America,South America and Caribbean Islands as direct destinations or on cruises to the samedestinations.
The trips last a minimum of 7 days and a maximum of 21 days.
Women of child bearing capacity who are not pregnant at the moment of screening (pregnancy test done on-site) and agree to use an acceptable form of birth control forthe duration of the study (e.g. Condom, oral contraceptives, etc.) are allowed toparticipate.
Exclusion
Exclusion Criteria:
active diarrhea;
pregnancy; breastfeeding
3 diarrheic episodes within 24 hours in the 15 days preceding the date of thedeparture;
antibiotic treatment during the last 15 days or ongoing treatment at the time ofdeparture;
consumption of fermented milk, yogourt or probiotics probiotics in the 15 dayspreceding the date of the departure;
immunosuppressed state or any health condition being susceptible to decompensateduring the study (including malignant hemo-pathologies, AIDS, bone marrow transplantor organ transplant).
active radiotherapy or chemotherapy as cancer treatment
the administration of an ETEC/cholera vaccine or any other diarrhea vaccine in thethree months prior to study initiation
an active, non-controlled intestinal disease;
ileostomy, jejunostomy or colostomy
concomitant participation in another clinical trial
mental or other conditions, or language barriers rendering the subject unable tounderstand the nature, scope, and possible consequences of the study or complete theself-administered questionnaires;
subject unlikely to comply with protocol, e.g., uncooperative attitude, andunlikelihood of completing the study,
allergies to any ingredients in the study product (active product or placebo)
current use of illicit drug and alcohol abuse
Study Design
Study Description
Connect with a study center
Clinique Santé Voyage des Prairies
Joliette, Quebec J6E 1G2
CanadaSite Not Available
Clinique Santé Voyage de Laval
Laval, Quebec H7G2E6
CanadaSite Not Available
Clinique Santé Voyage Saint-Luc
Montreal, Quebec H2X 2H9
CanadaSite Not Available
Sant Voyage Medisys
Montreal, Quebec H3A 3C6
CanadaSite Not Available
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