Environmental Enteric DysfunctionNCT02925026
Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
A study testing Lactoferrin and Lysozyme in people with Environmental Enteric Dysfunction, run by Washington University School of Medicine at 1 site in Malawi.
Trial summary
Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children Read more about this study
- Who is it for?
- Ages 12 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Environmental Enteric Dysfunction
- What is being tested?
- Lactoferrin and Lysozyme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 1 siteMalawi
- Study dates
- Oct 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 12-35 months
- youngest eligible child in each household
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children
- Conditions
- Environmental Enteric Dysfunction
- Being tested
- Lactoferrin, Lysozyme, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDietary supplement
LysozymeDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin+Lysozyme | Experimental | lactoferrin and lysozyme in rice flour Receives: Dietary Supplement: Lactoferrin; Dietary Supplement: Lysozyme |
| Placebo | Placebo comparator | rice flour Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Measured: 8 weeks
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Measured: 16 weeks
Secondary outcomes (4)
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Measured: 8 weeks
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Measured: 16 weeks
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Measured: 8 weeks
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Environmental Enteric DysfunctionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Principal investigator, Washington University in St. Louis; University of MalawiChrissie Thakwalakwa, PhD, Study director, Study DirectorIndi Trehan, MD MPH DTM&H, Study director, Washington University in St. Louis; University of Malawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925026
- Sponsor's protocol ID
- Lactoferrin-Lysozyme
- Status last verified
- May 2018
- First submitted
- 4 Oct 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29110675
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
- ClinicalTrials.gov ID
- NCT02925026
- Acronym / sponsor ID
- Lactoferrin-Lysozyme
- Conditions
- Environmental Enteric Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Malawi
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin+Lysozyme | Experimental | Dietary Supplement: Lactoferrin, Dietary Supplement: Lysozymelactoferrin and lysozyme in rice flour |
| Placebo | Placebo comparator | Dietary Supplement: Placeborice flour |
Who may qualify
- Ages
- 12 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 12-35 months
- youngest eligible child in each household
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoferrin | Dietary supplement | Lactoferrin+Lysozyme |
| Lysozyme | Dietary supplement | Lactoferrin+Lysozyme |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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
4 secondary outcomes
Lactulose Excretion
Time frame: 8 weeks
Lactulose Excretion
Time frame: 16 weeks
Mannitol Excretion
Time frame: 8 weeks
Mannitol Excretion
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 29110675Cheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J Manary, MD principal investigator
Washington University in St. Louis; University of Malawi
Chrissie Thakwalakwa, PhD study director
Study Director
Indi Trehan, MD MPH DTM&H study director
Washington University in St. Louis; University of Malawi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin and Lysozyme in people with Environmental Enteric Dysfunction, run by Washington University School of Medicine at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual Sugar Absorption Test (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02925026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.