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Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

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ClinicalTrials.gov Identifier: NCT02925026
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
University of Malawi
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 4, 2016
First Posted Date  ICMJE October 5, 2016
Last Update Posted Date May 2, 2018
Study Start Date  ICMJE October 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • Dual Sugar Absorption Test [ Time Frame: 8 weeks ]
    lactulose-mannitol ratio in urine
  • Dual Sugar Absorption Test [ Time Frame: 16 weeks ]
    lactulose-mannitol ratio in urine
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02925026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
  • Lactulose Excretion [ Time Frame: 8 weeks ]
    percentage of ingested lactulose excreted in urine
  • Lactulose Excretion [ Time Frame: 16 weeks ]
    percentage of ingested lactulose excreted in urine
  • Mannitol Excretion [ Time Frame: 8 weeks ]
    percentage of ingested mannitol excreted in urine
  • Mannitol Excretion [ Time Frame: 16 weeks ]
    percentage of ingested mannitol excreted in urine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 4, 2016)
Linear Growth [ Time Frame: 16 weeks ]
changes in linear growth
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
Official Title  ICMJE Not Provided
Brief Summary Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Environmental Enteric Dysfunction
Intervention  ICMJE
  • Dietary Supplement: Lactoferrin
  • Dietary Supplement: Lysozyme
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Experimental: Lactoferrin+Lysozyme
    lactoferrin and lysozyme in rice flour
    Interventions:
    • Dietary Supplement: Lactoferrin
    • Dietary Supplement: Lysozyme
  • Placebo Comparator: Placebo
    rice flour
    Intervention: Dietary Supplement: Placebo
Publications * Cheng WD, Wold KJ, Benzoni NS, Thakwalakwa C, Maleta KM, Manary MJ, Trehan I. Lactoferrin and lysozyme to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for a randomized controlled trial. Trials. 2017 Nov 6;18(1):523. doi: 10.1186/s13063-017-2278-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2018)
235
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2016)
250
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 35 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02925026
Other Study ID Numbers  ICMJE Lactoferrin-Lysozyme
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE University of Malawi
Investigators  ICMJE
Principal Investigator: Mark J Manary, MD Washington University in St. Louis; University of Malawi
Study Director: Chrissie Thakwalakwa, PhD Study Director
Study Director: Indi Trehan, MD MPH DTM&H Washington University in St. Louis; University of Malawi
PRS Account Washington University School of Medicine
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP