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

Last updated: July 26, 2022
Sponsor: Fertypharm
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

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: > 35 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
Study Start date:
May 05, 2021
Estimated Completion Date:
September 23, 2023

Study Description

After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will be randomized in a double-blind manner in a ratio 1:1 to receive the food supplementation associated with probiotics or placebo (folic acid) once daily.

Connect with a study center

  • Hospital de Sagunto

    Sagunto, Valencia 46520
    Spain

    Active - Recruiting

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