Gut DysbiosisNCT07869199
Gut Microbiota and Trichoscopic Changes in Women With Telogen Effluvium on a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study
An observational study of Gut Dysbiosis and Telogen Effluvium, run by Olistic Research Labs S.L. at 2 sites in Spain.
Trial summary
Telogen effluvium (TE) is a common cause of diffuse, non-scarring hair shedding in women. It is often triggered by physiological stress, nutritional deficiencies, illness or hormonal changes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gut Dysbiosis, Telogen Effluvium, Hair Loss
- What is being tested?
- Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consists of premenopausal women aged 18-40 years with a clinical and trichoscopic diagnosis of telogen effluvium and gut dysbiosis, attended at Clínica AB Derma and Clíncia Hbn39 of Madrid, Spain between January 2025 and July 2025. Eligible women received a multifactorial drinkable nutraceutical for 6 months as part of routine clinical care, and had gut microbiota analysis [at baseline and at 6 months] and trichoscopic assessment at baseline and at 6 months recorded in their medical records.
Who may be able to join
- Women aged 18-40 years.
- Premenopausal status.
- Diagnosis of telogen effluvium (TE) lasting more than 3 months.
- Digestive symptoms with no diagnosed underlying disease (gut microbiota dysbiosis).
Who cannot join
- Moderate or severe irritable bowel syndrome (IBS).
- Small intestinal bacterial overgrowth (SIBO).
- Prior use of the study product.
- Participation in similar studies or use of anti-hair-loss products within the previous 3 months.
- Skin or scalp diseases or disorders (e.g., psoriasis, dermatitis, eczema, cicatricial alopecia, or alopecia areata).
- Alopecia secondary to any medical condition (e.g., hypothyroidism, anaemia, lupus).
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- Chronic pharmacological treatment or a diagnosed systemic disease.
- Pregnancy, postpartum period (within 6 months), or breastfeeding.
- Previous abdominal surgery (except hysterectomy and appendectomy).
- Perimenopausal or menopausal status.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Clínica AB Derma
Madrid, Madrid, 28006
Clínica AB Derma, 034910241635, recepcion@abderma.es
Claudia Bernárdez, M.D., Ph.D.
Clínica Hbn39
Madrid, Madrid, 28036
Clínica Hbn39, 034910824675, administracion@hbn39.com
Silvia Gómez-Senent, M.D., Ph.D.
About this study
Official title: Gut Dysbiosis in Premenopausal Women With Telogen Effluvium, Baseline Characterization and 6-Month Trichoscopic Outcomes With a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study
Telogen effluvium (TE) is a common cause of diffuse, non-scarring hair shedding in women. It is often triggered by physiological stress, nutritional deficiencies, illness or hormonal changes. There is growing interest in the role of the gut microbiota in hair health, through its effects on nutrient absorption, immune regulation and systemic inflammation (the so-called gut-skin axis). However, data on gut microbiota in women with TE are still scarce.
This retrospective observational study will review the medical records of premenopausal women diagnosed with TE who received a multifactorial drinkable nutraceutical as part of routine clinical care at 2 clinics between January 2025 and July 2025. The study has two aims:
Read more
- To describe the gut microbiota profile of these women at baseline [and after 6 months], as assessed by [stool analysis method].
- To describe changes in trichoscopic parameters, over 6 months of supplementation [and to explore whether baseline microbiota features are associated with these changes].
The study does not assign any intervention: all data were collected during standard clinical practice. Its findings are intended to generate hypotheses for future controlled studies.
- Conditions
- Gut Dysbiosis, Telogen Effluvium, Hair Loss
- Being tested
- Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.Dietary supplement
Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, plant extracts, amino acids, and other bioactive compounds designed to support hair growth and scalp health in women.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for gut dysbiosis | Not described Receives: Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women. | |
| Patients referred for telogen effluvium | Not described Receives: Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of gut dysbiosis outcomes
Gus dysbiosis was analyzed with a stool kit test (KyberBioma(R)).
Measured: 6 months
Characterization of trichoscopic outcomes
Trychoscopy outcomes were measured using a phototrichoscope at the interparietal area. 7 trichoscopy signs were graded (0-3) from 2 evaluators: telangiectasias, punctate vessels, erythema, scaling, follicular miniaturization, follicular hyperkeratosis, fibrosis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut DysbiosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olistic Research Labs S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869199
- Sponsor's protocol ID
- CT-OW-04
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Dysbiosis in Premenopausal Women With Telogen Effluvium, Baseline Characterization and 6-Month Trichoscopic Outcomes With a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07869199
- Acronym / sponsor ID
- CT-OW-04
- Conditions
- Gut Dysbiosis, Telogen Effluvium, Hair Loss
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Olistic Research Labs S.L.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Oct 2026 (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.
Telogen effluvium (TE) is a common cause of diffuse, non-scarring hair shedding in women. It is often triggered by physiological stress, nutritional deficiencies, illness or hormonal changes. There is growing interest in the role of the gut microbiota in hair health, through its effects on nutrient absorption, immune regulation and systemic inflammation (the so-called gut-skin axis). However, data on gut microbiota in women with TE are still scarce.
This retrospective observational study will review the medical records of premenopausal women diagnosed with TE who received a multifactorial drinkable nutraceutical as part of routine clinical care at 2 clinics between January 2025 and July 2025. The study has two aims:
- To describe the gut microbiota profile of these women at baseline [and after 6 months], as assessed by [stool analysis method].
- To describe changes in trichoscopic parameters, over 6 months of supplementation [and to explore whether baseline microbiota features are associated with these changes].
The study does not assign any intervention: all data were collected during standard clinical practice. Its findings are intended to generate hypotheses for future controlled studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients referred for gut dysbiosis | – | Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women. |
| Patients referred for telogen effluvium | – | Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of premenopausal women aged 18-40 years with a clinical and trichoscopic diagnosis of telogen effluvium and gut dysbiosis, attended at Clínica AB Derma and Clíncia Hbn39 of Madrid, Spain between January 2025 and July 2025. Eligible women received a multifactorial drinkable nutraceutical for 6 months as part of routine clinical care, and had gut microbiota analysis [at baseline and at 6 months] and trichoscopic assessment at baseline and at 6 months recorded in their medical records.
Key inclusion criteria (4 listed)
- Women aged 18-40 years.
- Premenopausal status.
- Diagnosis of telogen effluvium (TE) lasting more than 3 months.
- Digestive symptoms with no diagnosed underlying disease (gut microbiota dysbiosis).
Key exclusion criteria (10 listed)
- Moderate or severe irritable bowel syndrome (IBS).
- Small intestinal bacterial overgrowth (SIBO).
- Prior use of the study product.
- Participation in similar studies or use of anti-hair-loss products within the previous 3 months.
- Skin or scalp diseases or disorders (e.g., psoriasis, dermatitis, eczema, cicatricial alopecia, or alopecia areata).
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 |
|---|---|---|
| Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, plant extracts, amino acids, and other bioactive compounds designed to support hair growth and scalp health in women. | Dietary supplement | Patients referred for gut dysbiosis, Patients referred for telogen effluvium |
Primary outcome
Characterization of gut dysbiosis outcomes
Time frame: 6 months
Gus dysbiosis was analyzed with a stool kit test (KyberBioma(R)).
Characterization of trichoscopic outcomes
Time frame: 6 months
Trychoscopy outcomes were measured using a phototrichoscope at the interparietal area. 7 trichoscopy signs were graded (0-3) from 2 evaluators: telangiectasias, punctate vessels, erythema, scaling, follicular miniaturization, follicular hyperkeratosis, fibrosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Dysbiosis and Telogen Effluvium, run by Olistic Research Labs S.L. at 2 sites 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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of gut dysbiosis outcomes (time frame: 6 months). 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?
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 9 Oct 2026.