Trial · NCT05434104
The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study
NCT05434104, Not applicable, Recruiting, Guy's and St Thomas' NHS Foundation Trust
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study. Trials, record NCT05434104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05434104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study
- NCT number
- NCT05434104
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 114 participants, estimated
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Conditions
- Bacterial Vaginosis, Candida Vaginal
- Interventions
- Vaginal lactoferrin, Usual care
- First posted
- 2022-06-27
- Last updated
- 2026-05-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The acceptability of vaginal lactoferrin treatment | 4-16 weeks after recruitment | This will be assessed from interviews with 15-20 participants |
| Primary | Adherence to treatment | During the first 4 weeks of the study | This will be assessed from participants' weekly count of remaining pessaries/tablets from questionnaires at 1, 2, 3 and 4 weeks |
| Primary | Recruitment rate | Up to 15 months | Investigators will record the percentage of eligible women who agree to take part |
| Primary | Follow-up rate | Up to 20 months | Investigators will record the percentage of randomised women who are followed up after 12 weeks |
| Secondary | Acceptability of study procedures, and whether participants think other women would be willing to take part in a future randomised trial of lactoferrin versus oral antibiotics. | 4-16 weeks after recruitment | Investigators will conduct telephone interviews between 4 and 16 weeks after recruitment with 15-20 participants |
| Secondary | Adverse events such as nausea, vomiting, vaginal irritation, abdominal pain, rashes, diarrhoea | Between recruitment and 12 week follow up | Investigators will ask about adverse events during weekly text questionnaires during the first four weeks and on the final questionnaire at 12 weeks follow up |
| Secondary | Recurrence or persistence of infection by 12 weeks | At 12 week follow up | Investigators will ask about symptoms of infection on the final 12 week questionnaire and assess infection status by analysis of self-taken vaginal samples |
| Secondary | Feasibility of obtaining data on healthcare use | Last 6 months of study | This will be assessed by comparing reported healthcare use in final 12 week questionnaires with a medical record search in 30 participants |
| Secondary | Percentage of participants who complete weekly symptom questionnaires for the first four weeks after recruitment. | During the 12 weeks after recruitment | This will be assessed from analysis of questionnaires. |
| Secondary | Percent of self-taken samples suitable for microbiological analysis | During the 12 weeks after recruitment | This will be assessed from microbiological analysis of self-taken vaginal samples |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05434104
GET https://conductscience.org/api/trials/v1/NCT05434104/registered