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NCT Number: NCT04935840

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pregnancy Related

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vithas Medimar, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 intakes throughout the study

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

Treatment and study plan

FertyBiotic Pregnancy

Dietary Supplement

DHA, folic acid, Iodine, iron, Lactobacillus rhamnosus, Lactobacillus reuterii, magnesium, zinc, vitamin D3, Vitamin C, Vitamin E, Group B vitamins and Biotin

Control

Other

400 mcg of folic acid

Primary outcomes

  1. Glucose homeostasis

    Time frame: 30-32 weeks gestation

    Glucose homeostasis status will be evaluated by measuring fasting glucose

Secondary outcomes

  1. Insulin levels

    Time frame: 30-32 weeks gestation

    Insulin levels status will be evaluated by measuring fasting insulin

  2. Insulin resistance

    Time frame: 30-32 weeks gestation

    Insulin resistance will be evaluated by measuring HOMA IR and QUICKI index (fasting glucose and fasting insulin combination)

  3. Weight gain

    Time frame: 30-32 weeks gestation

    Weight will be evaluated weighting the subjects

  4. Lipid concentration

    Time frame: 30-32 weeks gestation

    Lipid concentration will be evaluated by measuring fasting total colesterol, LDL, HDL and triglyceride

Sponsors and collaborators

Lead sponsor

Fertypharm

Industry

Registry information

Official study title

Clinical Study to Evaluate the Effect of a Food Supplement With Probiotics on the Metabolic Profile of Pregnant Women

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jun 23, 2021
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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