Alopecia AreataNCT05599607
Clinical Trial to Evaluate Effectiveness of a Probiotic Preparation Administered to Patients With Alopecia Areata
A study testing Probiotic mixture in people with Alopecia Areata, run by Bioithas SL at 1 site in Spain.
Trial summary
This study is part of a broader project that proposes the characterization of what we call the "Entire-Systemic Axis". It aims to study whether the bacteria present in the human skin microbiota and in the human intestinal microbiota can play a role in the pathophysiology of Alopecia Areata (AA), a fact that has not… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Probiotic mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 8 Mar 2021to 30 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AA diagnosis by clinical criteria.
- Show at least 2 signs of AA activity, visualized by trichoscopy
- Signature of informed consent by the patient, in accordance with the legislation on clinical trials.
Who cannot join
- Allergies or contraindication to take any of the components of the product under study.
- Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
- Consumption of probiotics in the previous 2 months. - Participation in clinical studies in the previous 2 months.
- Pregnancy and/or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind and Placebo-controlled Clinical Study to Evaluate the Effectiveness of a Probiotic Preparation Administered to Patients With Alopecia Areata
This study is part of a broader project that proposes the characterization of what we call the "Entire-Systemic Axis". It aims to study whether the bacteria present in the human skin microbiota and in the human intestinal microbiota can play a role in the pathophysiology of Alopecia Areata (AA), a fact that has not been studied to date. Based on the supposed relationship between the human microbiota and AA, we have formulated the hypothesis that the dietary supplementation of specific probiotic strains, with functional capacities on mucocutaneous tissue and its adnexa, could benefit patients with AA, acting on the patients' microbiome profile.
Read the detailed description
This clinical study was designed to be a randomized, double-blind, with parallel-groups, and placebo-controlled with a duration of 24 weeks duration.
The 24 weeks of intervention were structured in 6 face-to-face visits in consultation: visit 1 or initial (week 0), visit 2 (week 4), visit 3 (week 8), visit 4 (week 12), visit 5 (week 16) and visit 6 or end of study (week 24).
Visit 1 or initial (Week 0)
To recruit patients, all those voluntaries who attended the participating centre showing interest in the study with AA diagnosis meeting the criteria indicated in the study protocol were thoroughly informed of the study as well as of the implications of their participation.
Once the informed consent was signed a physician trained for the study conducted the initial interview The researcher proceeded to assign the patient a participant number in the study. According to a previously prepared randomization list, the patient was assigned the treatment received during the study by contacting the randomization centre Likewise, in this initial visit, the clinical history and capillary measurements were made: trichoscopy, plaques counting and photographs. In addition, the patient underwent a blood draw, and a skin sample from the area of plaques as well as sample of faeces was collected.
Finally, following the therapeutic protocol, a local infiltration of corticosteroids was performed and data from the DLQI subjective scale was collected.
The patient was given enough treatment to cover the period until the next scheduled visit according to its assigned code
Intermediate visits 2, 3 and 4 (Weeks 4, 8 and 12 respectively)
In addition to assessing the symptoms of the disease, the infiltration of topical corticosteroids and taking photographs was performed during these visits. The researcher recorded the adverse events reported by the patient (including the start date and in case those adverse events had already been resolved at the time of the visit the end date) as well as the accounting of the remaining product to evaluate treatment compliance in the Case Report Form (CRF).
The patient was given enough treatment to cover the period until the next scheduled visit according to its assigned code.
Intermediate Visit 5 (Week 16)
Besides performing the same procedures as in previous intermediate visits 2, 3 and 4, in this visit capillary measurements were added.
The patient was given enough treatment to cover the period until the next scheduled visit according to its assigned code
Visit 6 or final (Week 24)
During this final visit, the same procedures as in visit 1 were conducted, including capillary measurements and sample collection.
Possible adverse events were recorded, specifying the start and end dates, and the treatment received, if any. In addition, patient's leftover study product was collected
- Conditions
- Alopecia Areata
- Being tested
- Probiotic mixture, Placebo
- Keywords
- Probiotics
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic mixtureDietary supplement
Mixture of strains of lactobacillus and bifidobacteria
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Probiotic in capsule format administered orally. This probiotic product contains a mixture of strains of lactobacillus and bifidobacteria, called BTHS21, at concentrations equal to or greater than 1x109 cfu/dose. Receives: Dietary Supplement: Probiotic mixture |
| Placebo group | Placebo comparator | Maltodextrin, masked in an identical and indistinguishable format to that of the probiotic Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in signs of AA activity visualized by capillary trichoscopy at 16 and 24 weeks
The signs of AA activity assessed in trichoscopy were:
- Black dots (cadaveric hairs). Pigmented broken or fractured hairs at the level of the scalp
- Broken or exclamation mark hairs (peladic hairs). Fractured hairs with the distal end frayed and thicker.
- Broken hairs
- Tapered hairs (coudability hairs). Hairs of normal length, but with a narrower proximal shaft (indicating activity at the base of the hair).
- Pseudomonilethrix
Measured: 24 weeks
Changes from baseline in signs of AA inactivity visualized by capillary trichoscopy at 16 and 24 weeks
The signs of AA inactivity assessed in trichoscopy were:
- Yellow dots
- Fluffy hairs
- Empty follicular orifices
Measured: 24 weeks
Changes from baseline in signs of capillary repopulation visualized by capillary trichoscopy at 16 and 24 weeks
The signs of capillary repopulation assessed in trichoscopy were:
- Straight hairs in regrowth
- Pigtail hairs
- Fluffy hairs
Measured: 24 weeks
Secondary outcomes (18)
Changes from baseline in AA plaques number at 16 and 24 weeks
Plaques counting
Measured: 24 weeks
Changes from baseline in AA category/type at 16 and 24 weeks
Category types could be:
- Single
- Multifocal
- Total
- Universal
Measured: 24 weeks
Changes from baseline in SALT scale at 16 and 24 weeks
SALT scale measures the skin surface affected by AA, taking into account only the plaques on the scalp
Scores range from 0 to 5 depending on the percentage of affected scalp:
S0 = 0% S1 = 1 - 24% S2 = 25 - 49% S3 = 50 - 74% S4 = 75 - 99% S5 = 100%
Areas to be evaluated are distributed in 4 parts:
Right side (18%) Left side (18%) Top (40%) Back (24%)
% Total alopecia = Sum of the areas with alopecia
Measured: 24 weeks
Changes from baseline in haemoglobin values at 24 weeks
Haemoglobin values (g/dL)
Measured: 24 weeks
Changes from baseline in leukocytes values at 24 weeks
Leukocytes values (cel x 10^3/uL)
Measured: 24 weeks
Changes from baseline in platelets values at 24 weeks
Platelets values (cel x 10^3/uL)
Measured: 24 weeks
Changes from baseline in urea values at 24 weeks
Urea values (mg/dL)
Measured: 24 weeks
Changes from baseline in creatinine values at 24 weeks
Creatinine values (mg/dL)
Measured: 24 weeks
Changes from baseline in Thyroid-stimulating Hormone (TSH) values at 24 weeks
TSH values (mUI/L)
Measured: 24 weeks
Changes from baseline in C-reactive protein values at 24 weeks
C-reactive protein values (mg/L)
Measured: 24 weeks
Changes from baseline in Aspartate Aminotransferase (AST) values at 24 weeks
AST values (U/L)
Measured: 24 weeks
Changes from baseline in Alanine Aminotransferase (ALT) values at 24 weeks
ALT values (U/L)
Measured: 24 weeks
Changes from baseline in Interleukin-10 (IL-10) values at 24 weeks
IL-10 values (pg/mL)
Measured: 24 weeks
Changes from baseline in Tumor Necrosis Factor (TNF) values at 24 weeks
TNF values (pg/mL)
Measured: 24 weeks
Changes from baseline in Immunoglobulin E (IgE) values at 24 weeks
IgE values (U/mL)
Measured: 24 weeks
Changes from baseline in Dermatology Life Quality Index (DLQI) scale at 24 weeks
In DLQI scale, the patient answers a series of questions that assess the impact that Alopecia Areata has on their quality of life, categorizing each question as Very Much, Much, Little or Not at all.
Each question answered with "Very much" is counted with 3 points, "Much" with 2, "Slightly" with 1, and "Not at all" as 0.
The score obtained can range from 0 to 30 points, the latter being the worst possible score. The total score gives a value to the degree of impact of the disease on the patient's life:
0 - 1 = No effect 2 - 5 = Slight effect 6 - 10 = Moderate effect 11 - 20 = Very important effect 21 - 30 = Extremely important effect
Measured: 24 weeks
Changes from baseline in alpha diversity, beta diversity and composition of the skin and gut microbiota at 24 weeks
Microbiota study sequencing the R16s gene, from a skin sample and a stool sample.
Measured: 24 weeks
Adherence to treatment at 4,8,12,16 and 24 weeks
Count of remaining capsules
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start8 Mar 2021
- Primary completion8 Oct 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies 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
- Randomized, double-blind, with parallel-groups, and placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioithas SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bionou Research, S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599607
- Sponsor's protocol ID
- ALO.PRO
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 31 Oct 2022
- 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 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind and Placebo-controlled Clinical Study to Evaluate the Effectiveness of a Probiotic Preparation Administered to Patients With Alopecia Areata
- ClinicalTrials.gov ID
- NCT05599607
- Acronym / sponsor ID
- ALO.PRO
- Conditions
- Alopecia Areata
- Keywords
- Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bioithas SLIndustry (pharma, biotech, devices)
- Collaborators
- Bionou Research, S.L.
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 31 Oct 2022 (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.
This study is part of a broader project that proposes the characterization of what we call the "Entire-Systemic Axis". It aims to study whether the bacteria present in the human skin microbiota and in the human intestinal microbiota can play a role in the pathophysiology of Alopecia Areata (AA), a fact that has not been studied to date. Based on the supposed relationship between the human microbiota and AA, we have formulated the hypothesis that the dietary supplementation of specific probiotic strains, with functional capacities on mucocutaneous tissue and its adnexa, could benefit patients with AA, acting on the patients' microbiome profile.
Detailed description
This clinical study was designed to be a randomized, double-blind, with parallel-groups, and placebo-controlled with a duration of 24 weeks duration.
The 24 weeks of intervention were structured in 6 face-to-face visits in consultation: visit 1 or initial (week 0), visit 2 (week 4), visit 3 (week 8), visit 4 (week 12), visit 5 (week 16) and visit 6 or end of study (week 24).
Visit 1 or initial (Week 0)
To recruit patients, all those voluntaries who attended the participating centre showing interest in the study with AA diagnosis meeting the criteria indicated in the study protocol were thoroughly informed of the study as well as of the implications of their participation.
Once the informed consent was signed a physician trained for the study conducted the initial interview The researcher proceeded to assign the patient a participant number in the study. According to a previously prepared randomization list, the patient was assigned the treatment received during the study by contacting the randomization centre Likewise, in this initial visit, the clinical history and capillary measurements were made: trichoscopy, plaques counting and photographs. In addition, the patient underwent a blood draw, and a skin sample from the area of plaques as well as sample of faeces was collected.
Finally, following the therapeutic protocol, a local infiltration of corticosteroids was performed and data from the DLQI subjective scale was collected.
The patient was given enough treatment to cover the period until the next scheduled visit according to its assigned code
Intermediate visits 2, 3 and 4 (Weeks 4, 8 and 12 respectively)
In addition to assessing the symptoms of the disease, the infiltration of topical corticosteroids and taking photographs was performed during these visits. The researcher recorded the adverse events reported by the patient (including the start date and in case those adverse events had already been resolved at the time of the visit the end date) as well as the accounting of the remaining product to evaluate treatment compliance in the Case Report Form (CRF).
The patient was given enough treatment to cover the period until the next scheduled visit according to its assigned code.
Intermediate Visit 5 (Week 16)
Besides performing the same procedures as in previous intermediate visits 2, 3 and 4, in this visit capillary measurements were added.
The patient was given enough treatment to cover the period until the next scheduled visit according to its assigned code
Visit 6 or final (Week 24)
During this final visit, the same procedures as in visit 1 were conducted, including capillary measurements and sample collection.
Possible adverse events were recorded, specifying the start and end dates, and the treatment received, if any. In addition, patient's leftover study product was collected
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, with parallel-groups, and placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic mixtureProbiotic in capsule format administered orally. This probiotic product contains a mixture of strains of lactobacillus and bifidobacteria, called BTHS21, at concentrations equal to or greater than 1x109 cfu/dose. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin, masked in an identical and indistinguishable format to that of the probiotic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AA diagnosis by clinical criteria.
- Show at least 2 signs of AA activity, visualized by trichoscopy
- Signature of informed consent by the patient, in accordance with the legislation on clinical trials.
Key exclusion criteria (4 listed)
- Allergies or contraindication to take any of the components of the product under study.
- Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
- Consumption of probiotics in the previous 2 months. - Participation in clinical studies in the previous 2 months.
- Pregnancy and/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 |
|---|---|---|
| Probiotic mixtureMixture of strains of lactobacillus and bifidobacteria | Dietary supplement | Probiotic group |
| PlaceboMaltodextrin | Dietary supplement | Placebo group |
Primary outcome
Changes from baseline in signs of AA activity visualized by capillary trichoscopy at 16 and 24 weeks
Time frame: 24 weeks
The signs of AA activity assessed in trichoscopy were: * Black dots (cadaveric hairs). Pigmented broken or fractured hairs at the level of the scalp * Broken or exclamation mark hairs (peladic hairs). Fractured hairs with the distal end frayed and thicker. * Broken hairs * Tapered hairs (coudability hairs). Hairs of normal length, but with a narrower proximal shaft (indicating activity at the base of the hair). * Pseudomonilethrix
Changes from baseline in signs of AA inactivity visualized by capillary trichoscopy at 16 and 24 weeks
Time frame: 24 weeks
The signs of AA inactivity assessed in trichoscopy were: * Yellow dots * Fluffy hairs * Empty follicular orifices
Changes from baseline in signs of capillary repopulation visualized by capillary trichoscopy at 16 and 24 weeks
Time frame: 24 weeks
The signs of capillary repopulation assessed in trichoscopy were: * Straight hairs in regrowth * Pigtail hairs * Fluffy hairs
18 secondary outcomes
Changes from baseline in AA plaques number at 16 and 24 weeks
Time frame: 24 weeks
Changes from baseline in AA category/type at 16 and 24 weeks
Time frame: 24 weeks
Changes from baseline in SALT scale at 16 and 24 weeks
Time frame: 24 weeks
Changes from baseline in haemoglobin values at 24 weeks
Time frame: 24 weeks
Changes from baseline in leukocytes values at 24 weeks
Time frame: 24 weeks
Changes from baseline in platelets values at 24 weeks
Time frame: 24 weeks
Changes from baseline in urea values at 24 weeks
Time frame: 24 weeks
Changes from baseline in creatinine values at 24 weeks
Time frame: 24 weeks
Changes from baseline in Thyroid-stimulating Hormone (TSH) values at 24 weeks
Time frame: 24 weeks
Changes from baseline in C-reactive protein values at 24 weeks
Time frame: 24 weeks
Changes from baseline in Aspartate Aminotransferase (AST) values at 24 weeks
Time frame: 24 weeks
Changes from baseline in Alanine Aminotransferase (ALT) values at 24 weeks
Time frame: 24 weeks
Changes from baseline in Interleukin-10 (IL-10) values at 24 weeks
Time frame: 24 weeks
Changes from baseline in Tumor Necrosis Factor (TNF) values at 24 weeks
Time frame: 24 weeks
Changes from baseline in Immunoglobulin E (IgE) values at 24 weeks
Time frame: 24 weeks
Changes from baseline in Dermatology Life Quality Index (DLQI) scale at 24 weeks
Time frame: 24 weeks
Changes from baseline in alpha diversity, beta diversity and composition of the skin and gut microbiota at 24 weeks
Time frame: 24 weeks
Adherence to treatment at 4,8,12,16 and 24 weeks
Time frame: 24 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 31 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic mixture in people with Alopecia Areata, run by Bioithas SL at 1 site in Spain.
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 3 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 31 Oct 2022. 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 Spain. 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?
Changes from baseline in signs of AA activity visualized by capillary trichoscopy at 16 and 24 weeks (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 31 Oct 2022.