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Active, not recruitingNCT04935840Updated Dec 4, 2025

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

An interventional study of FertyBiotic Pregnancy and Control in Pregnancy Related, sponsored by Fertypharm. Active, not recruiting at 2 sites in Spain. Open to female participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Fertypharm · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Not applicable
Ages
35 Years and older
Sex
Female
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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.

Read the 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.

02

Conditions studied

  • Pregnancy Related
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In context

Lead sponsor

Fertypharm is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    FertyBiotic Pregnancy

    Participants received FertyBiotic Pregnancy one capsule a day

    Dietary Supplement: FertyBiotic Pregnancy · Other: Control

Interventions

  • Dietary supplementFertyBiotic Pregnancy

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

  • OtherControl

    400 mcg of folic acid

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What researchers measure

Primary outcomes

  1. Glucose homeostasis

    Glucose homeostasis status will be evaluated by measuring fasting glucose

    Time frame: 30-32 weeks gestation

Secondary outcomes

  1. Insulin levels

    Insulin levels status will be evaluated by measuring fasting insulin

    Time frame: 30-32 weeks gestation

  2. Insulin resistance

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

    Time frame: 30-32 weeks gestation

  3. Weight gain

    Weight will be evaluated weighting the subjects

    Time frame: 30-32 weeks gestation

  4. Lipid concentration

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

    Time frame: 30-32 weeks gestation

07

Study locations

2 sites
  • Hospital Vithas Medimar
    Alicante, Alicante, Spain
  • Centro Ginecologico Dra. García-Pérez Llantada
    Zaragoza, Zaragoza, Spain
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04935840
Lead sponsor
Fertypharm
Responsible party
Sponsor
First posted
Jun 23, 2021
Start date
May 5, 2021
Primary completion
Nov 1, 2025
Completion
Mar 23, 2026 (estimated)
Last update
Dec 4, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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