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

Fertypharm

Status: Active, not recruiting

Conditions: Pregnancy Related

Treatments: Other: Control; Dietary Supplement: FertyBiotic Pregnancy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04935840

2020_FBE_04

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

FertyBiotic Pregnancy

Experimental group

Description:

Participants received FertyBiotic Pregnancy one capsule a day

Treatment:

Dietary Supplement: FertyBiotic Pregnancy

Other: Control