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

November 26, 2025 updated by: Fertypharm

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Alicante, Alicante, Spain
        • Hospital Vithas Medimar
    • Zaragoza
      • Zaragoza, Zaragoza, Spain
        • Centro Ginecologico Dra. García-Pérez Llantada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FertyBiotic Pregnancy
Participants received FertyBiotic Pregnancy one capsule a day
Dietary supplement: FertyBiotic Pregnancy
DHA, folic acid, Iodine, iron, Lactobacillus rhamnosus, Lactobacillus reuterii, magnesium, zinc, vitamin D3, Vitamin C, Vitamin E, Group B vitamins and Biotin
Other: Control
400 mcg of folic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose homeostasis
Time Frame: 30-32 weeks gestation
Glucose homeostasis status will be evaluated by measuring fasting glucose
30-32 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin levels
Time Frame: 30-32 weeks gestation
Insulin levels status will be evaluated by measuring fasting insulin
30-32 weeks gestation
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)
30-32 weeks gestation
Weight gain
Time Frame: 30-32 weeks gestation
Weight will be evaluated weighting the subjects
30-32 weeks gestation
Lipid concentration
Time Frame: 30-32 weeks gestation
Lipid concentration will be evaluated by measuring fasting total colesterol, LDL, HDL and triglyceride
30-32 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fertypharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

November 1, 2025

Study Completion (Estimated)

March 23, 2026

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2020_FBE_04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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