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

Mondelez International

Status: Terminated

Conditions: Helminthiasis

Treatments: Other: Control Food Product; Other: Novel Food Product

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01271049

ABS-00-02

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Male or Female adults, age 18-45 years old inclusive on date of screening
• Showing presence of no or mild-moderate helminths

Exclusion criteria

• Presence of heavy helminth load
• Pregnant or lactating
• Hepatosplenomegaly or clinically significant abnormal hemoglobin, LAT or creatinine

Trial design

45 participants in 2 patient groups, including a placebo group

Control Food Product

Placebo Comparator group

Description:

Consumption of placebo food product

Treatment:

Other: Control Food Product

Novel Food Product

Experimental group

Description:

Consumption of novel food product

Treatment:

Other: Novel Food Product