Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108480098476 Date of Approval: 26/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lactolyze study (Boresha Afya)
Official scientific title Lactoferrin and lysozyme supplementation for long-term diarrhea sequelae
Brief summary describing the background and objectives of the trial The proposed study objective is to determine the efficacy of lactoferrin and lysozyme supplementation in decreasing diarrhea incidence and improving nutritional recovery in children recovering from diarrhea and wasting. In addition, we will explore whether these interventions improve outcomes by reducing enteric pathogens, improving enteric function and/or increasing hemoglobin concentrations in these children. Specifically, the study aims to (1) determine whether a 16-week course of lactoferrin, lysozyme or a combination of both shortens time to WHO-defined recovery from wasting (MUAC ≥12.5cm) and reduces the incidence of moderate-to-severe diarrhea during the subsequent 6-months following presentation to a health facility with diarrhea among children with moderate/severe childhood wasting (MUAC 12.5 cm at the time of screening) (2) explore whether a 16-week course of lactoferrin, lysozyme or combination therapy improves secondary clinical, nutritional, enteric pathogen, and enteric function outcomes (3) evaluate acceptability, adherence and cost-effectiveness of lactoferrin and/or lysozyme in Kenya.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Diarrhea and Malnutrition
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2022
Actual trial start date 10/03/2023
Anticipated date of last follow up 30/09/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
SERU 4274 Kenya Medical Research Institute - Scientific and Ethics Review Unit
ECCT211005 Kenya Pharmacy and Poisons Board
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lactoferrin Arm 41.5g 16 weeks Lactoferrin Arm will consist of Lactoferrin 1.5g and unmodified rice powder 40g 150
Experimental Group Lysozyme Arm 41.5g 16 weeks Lysozyme Arm will consist of Lysosure 40g and unmodified rice powder 1.5g 150
Experimental Group Lactoferrin and Lysozyme combination Arm 41.5g 16 weeks The combination Arm will consist of Lactoferrin 1.5g and Lysosure 40g 150
Control Group Placebo Arm 41.5g 16 weeks The Placebo Arm will consist of unmodified rice powder 41.5g 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
An eligible child will be aged 6-24 months Child is seen as an inpatient or outpatient for diarrhea who is ready to return home, with a MUAC <12.5 cm at the time of screening Child's caregiver consents for study participation Caregiver plan to remain in study area with the child for at least 6 months Child is not enrolled in another study Child is no longer exclusively breastfeeding Children younger than 6 months or older than 24 months Accompanying caregiver does not provide consent to study participation Caregiver reports the child will not stay within the study area for the next 6 months Child is enrolled in another study Child is exclusively breastfeeding at the time of enrolment Child is not yet discharged or discharged against medical advice Child has a history of congenital defect or syndrome that prevents age-appropriate feeding (e.g. cleft palate) Unwilling to participate in the dual sugar permeability sub-study if selected History of allergic reaction to dairy products Infant: 13 Month(s)-24 Month(s) 6 Month(s) 24 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/08/2021 Kenya Medical Research Institute Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of severe diarrhea Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24
Primary Outcome Time to nutritional recovery Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Secondary Outcome Severe diarrhea Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24
Secondary Outcome Dysentery Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24
Secondary Outcome Diarrhea (any severity) Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24
Secondary Outcome Medically-attended diarrhea Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24
Secondary Outcome Cumulative duration of diarrhea Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24
Secondary Outcome Incidence of hospitalization Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24
Secondary Outcome Hemoglobin concentration Weeks 16
Secondary Outcome Growth Baseline and weeks 4, 10, 16 and 24
Secondary Outcome Concentrations of specific markers of enteric function (fecal alpha antitrypsin [mg/g], myeloperoxidase [ng/mL] and calprotectin [mcg/g]) Baseline and weeks 4, 16 and 24
Secondary Outcome Prevalence of enteric infections Week 4 for all participants and at week 16 and 24 for a subset of participants
Secondary Outcome Acceptability Weeks 2, 4, 6, 8, 10, 12, 14 and 16
Secondary Outcome Adherence Weeks 2, 4, 6, 8, 10, 12, 14 and 16
Secondary Outcome Incremental cost-effectiveness Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Awendo SubCounty Hospital P.O Box 1 Awendo Migori 40405 Kenya
Homabay County Referral Hospital P.O Box 52 Homabay Homabay 40300 Kenya
Isebania SubCounty Hospital P.O Box 25 Isebania Migori 40414 Kenya
Kendu Adventist Mission Hospital P.O Box 20 Kendu Bay Homabay 40301 Kenya
Kisii Teaching and Referral Hospital P.O Box 92 Kisii Kisii 40200 Kenya
Mbita SubCounty Hospital P.O Box 50 Mbita Homabay 40305 Kenya
Rongo Sub County Hospital P.O Box 258 Rongo Migori 40404 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health 9000 Rockville Pike Bethesda Maryland 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Institute of Health 9000 Rockville Pike Bethesda Maryland 20892 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Benson Singa Kenya Medical Research Institute, Mbagathi Road Nairobi 00200 Kenya
Patricia Pavlinac University of Washington Seattle 98195 United States of America
Adeel Shah Aga Khan University Hospital Nairobi 00100 Kenya
Arianna Rubin Means University of Washington Seattle 98195 United States of America
Churchil Omondi Nyabinda Kenya Medical research Institute Nairobi 00200 Kenya
Doreen Rwigi Kenya Medical Research Institute Nairobi 00200 Kenya
Hannah Atlas University of Wshington Nairobi 98195 United States of America
Indi Trehan University of Washington Seattle 98105 United States of America
James Njunge KEMRI-Welcome Trust Research Program Kilifi 80108 Kenya
Judd Walson University of Washington Seattle 98195 United States of America
Kirk Tickell University of Washington Seattle 98195 United States of America
Joyce Otieno Kenya Medical Research Institute Nairobi 00200 Kenya
Lucia Keter Kenya Medical Research Institute Nairobi 00200 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Patricia Pavlinac ppav@uw.edu +16199926059 University of Washington
City Postal code Country Position/Affiliation
Seattle 98195 United States of America Assistant Professor
Role Name Email Phone Street address
Principal Investigator Benson Singa singabo2008@gmail.com +254725234844 Kenya Medical Research Institute, Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Research Scientist
Role Name Email Phone Street address
Public Enquiries Joyce Otieno joyotieno13@gmail.com +254780296370 Kenya Medical research Institute, Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Kirkby Tickell kirkbt@uw.edu +12064651900 2646 NW 62th Street
City Postal code Country Position/Affiliation
Seattle 98195 United States of America Trial Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results will be available after the publication of the main trial manuscript to the study team, Kenya Medical Research Institute, University of Washington, participating hospital staff and the community stakeholders. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 4 years Immediately after the publication of the trial manuscript
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information