Gut Microbiota and Trichoscopic Changes in Women With Telogen Effluvium on a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study

NCT07869199 | Not Yet Recruiting

• 1 other identifier: CT-OW-04
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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:

1. 1.To describe the gut microbiota profile of these women at baseline \[and after 6 months\], as assessed by \[stool analysis method\].
2. 2.To describe changes in trichoscopic parameters, over 6 months of supplementation \[and to explore whether baseline microbiota features are associated with these changes\].

Conditions

Gut Dysbiosis; Telogen Effluvium; Hair Loss

Outcome Measures

Primary Outcomes (2)

• Characterization of gut dysbiosis outcomes

  Gus dysbiosis was analyzed with a stool kit test (KyberBioma(R)).

  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.

  6 months

Study Arms (2)

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.

Interventions

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.

Patients referred for gut dysbiosis; Patients referred for telogen effluvium

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Olistic Research Labs S.L.: lead

Study Sites (2)

Clínica AB Derma

Madrid, Madrid, 28006, Spain

Location

Clínica Hbn39

Madrid, Madrid, 28036, Spain

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minerals; Plant Extracts

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

ES (2)