Evaluation of the Effect of FertyBiotic Pregnancy in the... | NCT04935840

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

NCT04935840

Sponsor

Fertypharm

Status

Active, not recruiting

Last Update Posted

Dec 4, 2025Actual

Enrollment

84Estimated

Phase

Not Applicable

Conditions

Pregnancy Related

Interventions

FertyBiotic Pregnancy
Control

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2021Actual

Primary Completion Date

Nov 1, 2025Actual

Completion Date

Mar 23, 2026Estimated

First Submitted Date

Jun 7, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FertyBiotic Pregnancy	Experimental	Participants received FertyBiotic Pregnancy one capsule a day	Dietary Supplement: FertyBiotic Pregnancy Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Insulin levels	Insulin levels status will be evaluated by measuring fasting insulin	30-32 weeks gestation
Insulin resistance	Insulin resistance will be evaluated by measuring HOMA IR and QUICKI index (fasting glucose and fasting insulin combination)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnancy

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Vithas Medimar		Alicante	Alicante		Spain
Centro Ginecologico Dra. García-Pérez Llantada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided