- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02925026
Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
May 1, 2018 updated by: Washington University School of Medicine
Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
235
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Blantyre, Malawi
- Malawi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children aged 12-35 months
- youngest eligible child in each household
Exclusion Criteria:
- severe or moderate acute malnutrition
- severe chronic illness
- children unable to drink 20 mL of dual sugar solution
- children in need of acute medical treatment for illness or injury at time of enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lactoferrin+Lysozyme
lactoferrin and lysozyme in rice flour
|
|
Placebo Comparator: Placebo
rice flour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dual Sugar Absorption Test
Time Frame: 8 weeks
|
lactulose-mannitol ratio in urine
|
8 weeks
|
Dual Sugar Absorption Test
Time Frame: 16 weeks
|
lactulose-mannitol ratio in urine
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lactulose Excretion
Time Frame: 8 weeks
|
percentage of ingested lactulose excreted in urine
|
8 weeks
|
Lactulose Excretion
Time Frame: 16 weeks
|
percentage of ingested lactulose excreted in urine
|
16 weeks
|
Mannitol Excretion
Time Frame: 8 weeks
|
percentage of ingested mannitol excreted in urine
|
8 weeks
|
Mannitol Excretion
Time Frame: 16 weeks
|
percentage of ingested mannitol excreted in urine
|
16 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Linear Growth
Time Frame: 16 weeks
|
changes in linear growth
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Chrissie Thakwalakwa, PhD, Study Director
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
October 4, 2016
First Submitted That Met QC Criteria
October 4, 2016
First Posted (Estimate)
October 5, 2016
Study Record Updates
Last Update Posted (Actual)
May 2, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lactoferrin-Lysozyme
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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