Herpes LabialisEVIM2NCT03310294
Immune Evidence to the Consumption of Lactobacillus GG and FOS Consumption in Patients With Herpes Labialis
A study testing Prebiotics and Probiotics in people with Herpes Labialis, run by Sprim Advanced Life Sciences.
Trial summary
Herpes labialis (HL) is the result of the presence of a virus called HSV-1 and is a common disease. Because of its visibility due to cold sores it has a serious impact on social life. Until now there is no effective treatment to prevent virus outbreaks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- Prebiotics and Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2010to 1 Aug 2011
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy free-living men and women aged 18 to 65 years-old.
- History of recurrent HL (2 - 4 episodes) after exposure to sunlight in the previous 12 months.
- Fitzpatrick skin type 1 to 4 (appendix 1 of the study protocol).
- No presence of HL lesions at time of recruitment, including baseline.
- Agreement to adhere to the prescribed list of dietary recommendations provided at the start of the study (appendix 3 of the study protocol).
- Women of child-bearing potential are required to use adequate birth protection during the study.
- Sign and date the ICF to and to comply with study procedures
Who cannot join
- Presence of acute/terminal disease.
- Intolerance for milk protein or lactose.
- Treatment with acyclovir or other medication believed to interfere with immune responses at the time of the study.
- Participation in any herpes UV reactivation study within the previous three months.
- Pregnancy or lactation.
- Any condition (e.g. schizophrenia, psychosis, major depression or mental deficiency) or major co-morbidity that the study investigator thinks might compromise the person's ability to comply with the requirements of the study.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Multicenter Clinical Study to Evaluate the Effect of a Combination of Probiotics and Prebiotics in Subjects With Recurrent Herpes Labialis
Herpes labialis (HL) is the result of the presence of a virus called HSV-1 and is a common disease. Because of its visibility due to cold sores it has a serious impact on social life. Until now there is no effective treatment to prevent virus outbreaks. However, prebiotics and probiotics have both been shown to have a favorable and supportive effect on the immune system in different health conditions such as influenza, atopic dermatitis and diarrhea, so it is possible that they are able to have a favourable effect also on HL.
A recently completed pilot clinical trial (Protocol Number 08-SBUS-2-GRA-01, EVIM-1) was completed using a fermented milk (minidrink) containing a combination of L. rhamnosus and FOS; it showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1. The study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general, showing that the consumption of a minidrink containing the probiotic L. rhamnosus or a minidrink containing a combination of L. rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions.
Read more
Aim of this study: corroborate whether the consumption of a minidrink containing a combination of L. rhamnosus and FOS results in less recurrence and a better progression of HL lesion, in a larger population. In addition, the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated.
Design: 152 patients were eligible to participate in the study and after a run-in period of two weeks consuming a placebo minidrink were randomized to one of the two experimental study groups: placebo minidrink (n=79) and a minidrink containing a combination of a pre- and probiotic (n=78). These minidrinks were consumed until the end of the study (day 140). At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB to provoke a lesion. During the entire study period subjects were checked for any clinical signs of a lesion, completed a self-assessment regarding the lesion and a QoL questionnaire at baseline (day 14), at day 49 and the end of the study (day 140). In addition, a blood sample was collected at baseline, at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations , to check immune system specific functions.
Read the detailed description
Background: Herpes labialis is the result of the presence of HSV-1 and is a common disease. Because of its visibility it has a serious impact on social life. Until now there is no effective treatment to prevent virus outbreaks. However, prebiotics and probiotics have both been shown to have a favorable and supportive effect on the immune system in different health conditions such as influenza, atopic dermatitis and diarrhea.
A recently completed pilot clinical trial (Protocol Number 08-SBUS-2-GRA-01, EVIM-1) parallel groups, placebo controlled, triple blind, single center, randomized study, with a fermented milk (minidrink) containing a combination of L. rhamnosus and FOS showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1; the study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general, showing that the consumption of a minidrink containing the probiotic L. rhamnosus or a minidrink containing a combination of L. rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions.
Aim of the study: corroborate whether the consumption of a minidrink containing a combination of L. rhamnosus and FOS results in less recurrence and a better progression of HL lesion, in a larger population. In addition, the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated.
Design: 152 patients were eligible to participate in the study and after a run-in period of two weeks consuming a placebo minidrink were randomized to one of the two experimental study groups: placebo minidrink (n=79) and a minidrink containing a combination of a pre- and probiotic (n=78). These minidrinks were consumed until the end of the study (day 140). At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB to provoke a lesion. During the entire study period subjects were checked for any clinical signs of a lesion, completed a self-assessment regarding the lesion and a QoL questionnaire at baseline (day 14), at day 49 and the end of the study (day 140). In addition, a blood sample was collected at baseline, at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations (circulating concentrations of IgG1 and IgG3 (Th1) and IgG4 (Th2), NK activity, CXCL10 analyzed by ELISA at days 14, 49 and 140).
as regards the primary endpoint results have shown that there was a significant decrease (54.3%) in the recurrences of Herpes labialis lesions, post UV stimulation, at day 49 (V4) compared to placebo in the PP population with consumption of the study product minidrink with fermented low fat milk added with Lactobacillus rhamnosus and FOS. Considering the secondary endpoints in the PP population, considering the number of subjects who presented lesions between V0 and V5, the number of lesions is reduced significantly (both statistically and clinically) in the treatment group compared to the placebo group. There was a decrease in the lesion size in the treatment group when compared to placebo although the statistical significance is marginal. As regards 'Subjective assessment of pain', evaluated by means of a VAS scale, significant pain reduction was found in the treatment group compared to the placebo group. As regards immunological parameters was shown an increase in CXCL10 at V4 in the study group compared to the placebo group. As regards IgG1, IgG3 and IgG4 (V0, V4 and V5) although substantial increases were registered for some of these parameters, these were not sufficient to describe a definite trend. The natural killer (NK) cell activity did not show significant difference in their functional activity in the treatment group as compared to the placebo group.
It has been verified through quality of life questionnaire (SF-36 questionnaire) that treatment improved Mental Health in the treatment group (Nervous, Peaceful, Happy, Down in Dumps, Sad) compared to the placebo group and clinical significance was found at V4 and V5. General Health and Vitality has been improved at V4 and V5.
For each trial participant the adverse events/serious adverse events occurrences and a brief clinical examination were assessed. No special or unusual features of the safety evaluations were found.
- Conditions
- Herpes Labialis
- Being tested
- Placebo, Prebiotics and Probiotics
- Keywords
- Lactobacillus, Herpes Labial, Immune repsonse
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
one bottle of placebo (minidrink fermented with low-fat milk but without Lactobacillus rhamnosus and without FOS, and without viable bacteria 90 grams)per day at breakfast until the end of the study (V5, day 140). At each visit, subjects were dispensed a sufficient amount of minidrinks until the next visit.
Prebiotics and ProbioticsDietary supplement
one bottle of the study product (minidrink with fermented low-fat milk added with Lactobacillus rhamnosus (Lactobacillus rhamnosus) and fructooligosaccharides (FOS),per day at breakfast until the end of the study (V5, day 140). At each visit, subjects were dispensed a sufficient amount of minidrinks until the next visit.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | one bottle of placebo (minidrink fermented with low-fat milk but without Lactobacillus rhamnosus and without FOS, and without viable bacteria 90 grams) Receives: Dietary Supplement: Placebo |
| Prebiotics and Probiotics | Active comparator | one bottle of the study product (minidrink with fermented low-fat milk added with Lactobacillus rhamnosus (Lactobacillus rhamnosus) and fructooligosaccharides (FOS), 90 grams) Receives: Dietary Supplement: Prebiotics and Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of HL recurrence.
to evaluate the coadjuvant effect of the combination of prebiotic and probiotic mix in the reduction of the number of HL recurrences at day 49 vs baseline.
Measured: Day 49
Secondary outcomes (14)
reduction of HL recurrence.
to evaluate the coadjuvant effect of the combination of prebiotic and probiotic mix in the reduction of the number of HL recurrences at day 49 vs baseline.
Measured: day 14
reduction of HL recurrence.
to evaluate the coadjuvant effect of the combination of prebiotic and probiotic mix in the reduction of the number of HL recurrences at day 49 vs baseline.
Measured: day 140
change IGS markers concentration
Evaluate the effect of the combination of prebiotic and probiotic mix on specific IGs markers;
Measured: day 14
change IGS markers concentration
Evaluate the effect of the combination of prebiotic and probiotic mix on specific IGs markers;
Measured: day 49
change IGS markers concentration
Evaluate the effect of the combination of prebiotic and probiotic mix on specific IGs markers;
Measured: day 140
time to healing
Evaluate the coadjuvant effect of the combination of prebiotic and probiotic mix in the time to healing, defined as either loss of the hard crust or return to normal skin (measured in days);
Measured: Day 14
time to healing
Evaluate the coadjuvant effect of the combination of prebiotic and probiotic mix in the time to healing, defined as either loss of the hard crust or return to normal skin (measured in days);
Measured: Day 49
time to healing
Evaluate the coadjuvant effect of the combination of prebiotic and probiotic mix in the time to healing, defined as either loss of the hard crust or return to normal skin (measured in days);
Measured: Day 140
lesion size
Evaluate measurement of lesion size as a product of the length and the width of the lesion development (measured in mm2) by classification of lesion stage
Measured: Day 14
lesion size
Evaluate measurement of lesion size as a product of the length and the width of the lesion development (measured in mm2) by classification of lesion stage
Measured: Day 49
lesion size
Evaluate measurement of lesion size as a product of the length and the width of the lesion development (measured in mm2) by classification of lesion stage
Measured: Day 140
SF-36
Evaluate quality of life by means of SF-36 questionnaire
Measured: Day 14
SF-36
Evaluate quality of life by means of SF-36 questionnaire
Measured: Day 49
SF-36
Evaluate quality of life by means of SF-36 questionnaire
Measured: Day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start14 Sep 2010
- Primary completion5 May 2011
- Study completion1 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- 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
- Model description
- This is a phase IV, parallel, placebo-controlled, double-blind, multicenter, randomized study to evaluate the effect of a combination of probiotics and prebiotics in subjects with recurrent Herpes labialis. This specific design has been chosen as the most suitable to achieve the objectives of the trial, mainly the demonstration of the clinical efficacy of the combination of probiotics and prebiotics in subjects with recurrent Herpes labialis in terms of reduction of the number of HL recurrences at day 49 vs baseline.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sprim Advanced Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelangelo La Placa, master, Principal investigator, Dipartimento di Medicina Interna, dell'Invecchiamento e Malattie Nefrologiche Università degli Studi di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310294
- Sponsor's protocol ID
- 10-CLI-GRA-02
- Acronym
- EVIM2
- Status last verified
- Oct 2017
- First submitted
- 4 Oct 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Multicenter Clinical Study to Evaluate the Effect of a Combination of Probiotics and Prebiotics in Subjects With Recurrent Herpes Labialis
- ClinicalTrials.gov ID
- NCT03310294
- Acronym / sponsor ID
- EVIM2 / 10-CLI-GRA-02
- Conditions
- Herpes Labialis
- Keywords
- Lactobacillus, Herpes Labial, Immune repsonse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Sprim Advanced Life SciencesUniversity, hospital or other
- Study start
- 14 Sep 2010 (actual)
- Primary completion
- 5 May 2011 (actual)
- Study completion
- 1 Aug 2011 (actual)
- First posted
- 16 Oct 2017 (actual)
- 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.
Herpes labialis (HL) is the result of the presence of a virus called HSV-1 and is a common disease. Because of its visibility due to cold sores it has a serious impact on social life. Until now there is no effective treatment to prevent virus outbreaks. However, prebiotics and probiotics have both been shown to have a favorable and supportive effect on the immune system in different health conditions such as influenza, atopic dermatitis and diarrhea, so it is possible that they are able to have a favourable effect also on HL.
A recently completed pilot clinical trial (Protocol Number 08-SBUS-2-GRA-01, EVIM-1) was completed using a fermented milk (minidrink) containing a combination of L. rhamnosus and FOS; it showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1. The study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general, showing that the consumption of a minidrink containing the probiotic L. rhamnosus or a minidrink containing a combination of L. rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions.
Aim of this study: corroborate whether the consumption of a minidrink containing a combination of L. rhamnosus and FOS results in less recurrence and a better progression of HL lesion, in a larger population. In addition, the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated.
Design: 152 patients were eligible to participate in the study and after a run-in period of two weeks consuming a placebo minidrink were randomized to one of the two experimental study groups: placebo minidrink (n=79) and a minidrink containing a combination of a pre- and probiotic (n=78). These minidrinks were consumed until the end of the study (day 140). At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB to provoke a lesion. During the entire study period subjects were checked for any clinical signs of a lesion, completed a self-assessment regarding the lesion and a QoL questionnaire at baseline (day 14), at day 49 and the end of the study (day 140). In addition, a blood sample was collected at baseline, at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations , to check immune system specific functions.
Detailed description
Background: Herpes labialis is the result of the presence of HSV-1 and is a common disease. Because of its visibility it has a serious impact on social life. Until now there is no effective treatment to prevent virus outbreaks. However, prebiotics and probiotics have both been shown to have a favorable and supportive effect on the immune system in different health conditions such as influenza, atopic dermatitis and diarrhea.
A recently completed pilot clinical trial (Protocol Number 08-SBUS-2-GRA-01, EVIM-1) parallel groups, placebo controlled, triple blind, single center, randomized study, with a fermented milk (minidrink) containing a combination of L. rhamnosus and FOS showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1; the study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general, showing that the consumption of a minidrink containing the probiotic L. rhamnosus or a minidrink containing a combination of L. rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions.
Aim of the study: corroborate whether the consumption of a minidrink containing a combination of L. rhamnosus and FOS results in less recurrence and a better progression of HL lesion, in a larger population. In addition, the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated.
Design: 152 patients were eligible to participate in the study and after a run-in period of two weeks consuming a placebo minidrink were randomized to one of the two experimental study groups: placebo minidrink (n=79) and a minidrink containing a combination of a pre- and probiotic (n=78). These minidrinks were consumed until the end of the study (day 140). At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB to provoke a lesion. During the entire study period subjects were checked for any clinical signs of a lesion, completed a self-assessment regarding the lesion and a QoL questionnaire at baseline (day 14), at day 49 and the end of the study (day 140). In addition, a blood sample was collected at baseline, at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations (circulating concentrations of IgG1 and IgG3 (Th1) and IgG4 (Th2), NK activity, CXCL10 analyzed by ELISA at days 14, 49 and 140).
as regards the primary endpoint results have shown that there was a significant decrease (54.3%) in the recurrences of Herpes labialis lesions, post UV stimulation, at day 49 (V4) compared to placebo in the PP population with consumption of the study product minidrink with fermented low fat milk added with Lactobacillus rhamnosus and FOS. Considering the secondary endpoints in the PP population, considering the number of subjects who presented lesions between V0 and V5, the number of lesions is reduced significantly (both statistically and clinically) in the treatment group compared to the placebo group. There was a decrease in the lesion size in the treatment group when compared to placebo although the statistical significance is marginal. As regards 'Subjective assessment of pain', evaluated by means of a VAS scale, significant pain reduction was found in the treatment group compared to the placebo group. As regards immunological parameters was shown an increase in CXCL10 at V4 in the study group compared to the placebo group. As regards IgG1, IgG3 and IgG4 (V0, V4 and V5) although substantial increases were registered for some of these parameters, these were not sufficient to describe a definite trend. The natural killer (NK) cell activity did not show significant difference in their functional activity in the treatment group as compared to the placebo group.
It has been verified through quality of life questionnaire (SF-36 questionnaire) that treatment improved Mental Health in the treatment group (Nervous, Peaceful, Happy, Down in Dumps, Sad) compared to the placebo group and clinical significance was found at V4 and V5. General Health and Vitality has been improved at V4 and V5.
For each trial participant the adverse events/serious adverse events occurrences and a brief clinical examination were assessed. No special or unusual features of the safety evaluations were found.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a phase IV, parallel, placebo-controlled, double-blind, multicenter, randomized study to evaluate the effect of a combination of probiotics and prebiotics in subjects with recurrent Herpes labialis. This specific design has been chosen as the most suitable to achieve the objectives of the trial, mainly the demonstration of the clinical efficacy of the combination of probiotics and prebiotics in subjects with recurrent Herpes labialis in terms of reduction of the number of HL recurrences at day 49 vs baseline.
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Placeboone bottle of placebo (minidrink fermented with low-fat milk but without Lactobacillus rhamnosus and without FOS, and without viable bacteria 90 grams) |
| Prebiotics and Probiotics | Active comparator | Dietary Supplement: Prebiotics and Probioticsone bottle of the study product (minidrink with fermented low-fat milk added with Lactobacillus rhamnosus (Lactobacillus rhamnosus) and fructooligosaccharides (FOS), 90 grams) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy free-living men and women aged 18 to 65 years-old.
- History of recurrent HL (2 - 4 episodes) after exposure to sunlight in the previous 12 months.
- Fitzpatrick skin type 1 to 4 (appendix 1 of the study protocol).
- No presence of HL lesions at time of recruitment, including baseline.
- Agreement to adhere to the prescribed list of dietary recommendations provided at the start of the study (appendix 3 of the study protocol).
Key exclusion criteria (6 listed)
- Presence of acute/terminal disease.
- Intolerance for milk protein or lactose.
- Treatment with acyclovir or other medication believed to interfere with immune responses at the time of the study.
- Participation in any herpes UV reactivation study within the previous three months.
- Pregnancy or lactation.
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 |
|---|---|---|
| Placeboone bottle of placebo (minidrink fermented with low-fat milk but without Lactobacillus rhamnosus and without FOS, and without viable bacteria 90 grams)per day at breakfast until the end of the study (V5, day 140). At each visit, subjects were dispensed a sufficient amount of minidrinks until the next visit. | Dietary supplement | placebo |
| Prebiotics and Probioticsone bottle of the study product (minidrink with fermented low-fat milk added with Lactobacillus rhamnosus (Lactobacillus rhamnosus) and fructooligosaccharides (FOS),per day at breakfast until the end of the study (V5, day 140). At each visit, subjects were dispensed a sufficient amount of minidrinks until the next visit. | Dietary supplement | Prebiotics and Probiotics |
Primary outcome
reduction of HL recurrence.
Time frame: Day 49
to evaluate the coadjuvant effect of the combination of prebiotic and probiotic mix in the reduction of the number of HL recurrences at day 49 vs baseline.
14 secondary outcomes
reduction of HL recurrence.
Time frame: day 14
reduction of HL recurrence.
Time frame: day 140
change IGS markers concentration
Time frame: day 14
change IGS markers concentration
Time frame: day 49
change IGS markers concentration
Time frame: day 140
time to healing
Time frame: Day 14
time to healing
Time frame: Day 49
time to healing
Time frame: Day 140
lesion size
Time frame: Day 14
lesion size
Time frame: Day 49
lesion size
Time frame: Day 140
SF-36
Time frame: Day 14
SF-36
Time frame: Day 49
SF-36
Time frame: Day 140
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 16 Oct 2017.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
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.
Michelangelo La Placa, master principal investigator
Dipartimento di Medicina Interna, dell'Invecchiamento e Malattie Nefrologiche Università degli Studi di Bologna
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotics and Probiotics in people with Herpes Labialis, run by Sprim Advanced Life Sciences.
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 7 inclusion and 6 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 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
reduction of HL recurrence. (time frame: Day 49). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2017.