Autoprobiotic Enterococcus supplements for the treatment of metabolic syndrome

In patients with metabolic syndrome (Participants), do autoprobiotic supplements based on indigenous non-pathogenic Enterococcus faecium and Enterococcus hirae strains (Intervention), compared to placebo (Comparison), improve anthropometric parameters, carbohydrate and lipid metabolism, and gut microbiota composition (Outcomes): a pilot randomized, placebo-controlled trial (APMETS-Pilot)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30134752

Enrollment

Registered

2026-06-05

Start date

2023-05-15

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome (MetS)

Interventions

Randomization was based on a pre-computer-generated random assignment sequence using the block method

distribution concealment was ensured using sequentially numbered opaque sealed envelopes. At enrollment, eligible participants were assigned a unique identification number and were randomized (1:1) (

n = 25) – Autoprobiotic: Non-pathogenic, indigenous Enterococcus faecium or Enterococcus hirae strains isolated from each participant's own fecal sample are grown to prepare a personalised functional

n = 25) – Placebo: Participants receive SuproPlus 2640 (Monsanto Company, MO, USA

40 g/L nutrient medium) – the same medium used as the base for autoprobiotic cultivation – witho

Eligibility

Sex/Gender

All

Age

25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of metabolic syndrome 2. Age 25 to 75 years (men and women) 3. Overweight or abdominal obesity: BMI > 25 kg/m² AND waist circumference = 94 cm in men or = 80 cm in women 4. Altered lipid profile consistent with hyperlipidemia types of IIa or IIb (Fredrickson classification) 5. Disorder of carbohydrate metabolism presenting as impaired glucose tolerance 6. Signed voluntary informed consent 7. Lower age limit: 25 years 8. Upper age limit: 75 years 9. Sex: Both male and female (sex-matched allocation between groups)

Exclusion criteria

Exclusion criteria: 1. Concomitant diseases requiring constant or long-term therapy that could affect study results 2. Cancer or myeloproliferative diseases 3. Substance or alcohol abuse 4. Current pregnancy or at the stage of pregnancy planning 5. Current use of antibacterial, antiviral, antifungal, or antiprotozoal drugs 6. Use of laxatives, cleansing enemas, probiotics, or dietary supplements within 14 days prior to enrolment (wash-out required). If the patient needed to change therapy (or it was recently changed), if there were recent lifestyle changes (nutrition, physical activity), then the patient's inclusion was postponed until stabilization for 2-4 weeks. The conditions for inclusion in the study were stable therapy, a stable diet, and a stable level of physical activity. 7. Use of lactic acid products within 14 days prior to enrolment

Countries

Russian Federation

Contacts

Public ContactElena Ermolenko

Lermolenko1@yandex.ru+7(812) 2340542

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026