Evaluation of the Effect of FertyBiotic Pregnancy in the Metabolic Profile in Pregnant Women

Last updated: November 26, 2025
Sponsor: Fertypharm
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Control

FertyBiotic Pregnancy

Clinical Study ID

NCT04935840
2020_FBE_04
  • Ages > 35
  • Female
  • Accepts Healthy Volunteers

Study Summary

The aim of this study is determine the effect of a food supplement with probiotics on metabolic profile and weight gain in pregnant women.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women

  • Age: > 18 years old

  • BMI > 25

  • Women who have signed the informed consent to participate in the study.

  • No intention to change their routine physical activity or usual dietary intakesthroughout the study

Exclusion

Exclusion Criteria:

  • > 14 weeks' gestation

  • Taking food supplements or probiotics

  • History or current pathology that influence in the study

  • With major fetal abnormalities

  • Had used continuous antibiotic therapy for at least 3 months

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Control
Phase:
Study Start date:
May 05, 2021
Estimated Completion Date:
March 23, 2026

Study Description

After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent all patients will be treated with the food supplement that contain vitamins, minerals and probiotics. All volunteers will receive one capsule per day of the food supplement throughout the study. The duration of the supplementation will be from their inclusion in the study (≤ 14 weeks of gestation) until the 30th-32nd week of pregnancy, the time of the end-of-study visit.

Connect with a study center

  • Hospital Vithas Medimar

    Alicante 2521978, Alicante
    Spain

    Site Not Available

  • Hospital de Sagunto

    Sagunto, Valencia 46520
    Spain

    Site Not Available

  • Centro Ginecologico Dra. García-Pérez Llantada

    Zaragoza 3104324, Zaragoza
    Spain

    Site Not Available

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