NCT04935840

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

4.5 years

First QC Date

June 7, 2021

Last Update Submit

November 26, 2025

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Glucose homeostasis

    Glucose homeostasis status will be evaluated by measuring fasting glucose

    30-32 weeks gestation

Secondary Outcomes (4)

  • Insulin levels

    30-32 weeks gestation

  • Insulin resistance

    30-32 weeks gestation

  • Weight gain

    30-32 weeks gestation

  • Lipid concentration

    30-32 weeks gestation

Study Arms (1)

FertyBiotic Pregnancy

EXPERIMENTAL

Participants received FertyBiotic Pregnancy one capsule a day

Dietary Supplement: FertyBiotic PregnancyOther: Control

Interventions

FertyBiotic PregnancyDIETARY_SUPPLEMENT

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

FertyBiotic Pregnancy
ControlOTHER

400 mcg of folic acid

FertyBiotic Pregnancy

Eligibility Criteria

Age35 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \> 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Vithas Medimar

Alicante, Alicante, Spain

Location

Centro Ginecologico Dra. García-Pérez Llantada

Zaragoza, Zaragoza, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 23, 2021

Study Start

May 5, 2021

Primary Completion

November 1, 2025

Study Completion

March 23, 2026

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)