Clinical Trial: An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Double-blind, Randomized, Controlled Evaluation of the Tolerability of a Proprietary Oil Blend in Adults Residing in Areas Endemic for Helminth Infections.

Brief Summary: The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.

Detailed Summary:
Sponsor: Mondelēz International, Inc.

Current Primary Outcome: Measure of Safety and Tolerability using the Reactogenicity Questionairre [ Time Frame: 43 days ]

Reactogenicity will be assessed using a structured questionnaire on days 2, 14, 28, and 42 of the study. In addition, blood will be collected on study days 14 and 42 for assessment of basic hematologic and clinical chemistry parameters.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mondelēz International, Inc.

Dates:
Date Received: January 3, 2011
Date Started: January 2011
Date Completion:
Last Updated: December 11, 2012
Last Verified: December 2012