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

NCT ID: NCT04935840

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2026-03-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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FertyBiotic Pregnancy

Participants received FertyBiotic Pregnancy one capsule a day

Group Type EXPERIMENTAL

FertyBiotic Pregnancy

Intervention Type 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

Intervention Type OTHER

400 mcg of folic acid

Interventions

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FertyBiotic Pregnancy

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

Intervention Type DIETARY_SUPPLEMENT

Control

400 mcg of folic acid

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fertypharm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Vithas Medimar

Alicante, Alicante, Spain

Site Status

Centro Ginecologico Dra. García-Pérez Llantada

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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2020_FBE_04

Identifier Type: -

Identifier Source: org_study_id

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