Pregnancy RelatedNCT04935840
Evaluation of the Effect of FertyBiotic Pregnancy in the Metabolic Profile in Pregnant Women
A study testing FertyBiotic Pregnancy in people with Pregnancy Related, run by Fertypharm at 2 sites in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- FertyBiotic Pregnancy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesSpain
- Study dates
- 5 May 2021to 23 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- > 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Vithas Medimar
Alicante, Alicante
Centro Ginecologico Dra. García-Pérez Llantada
Zaragoza, Zaragoza
About this study
Official title: Clinical Study to Evaluate the Effect of a Food Supplement With Probiotics on the Metabolic Profile of Pregnant Women
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.
- Conditions
- Pregnancy Related
- Being tested
- FertyBiotic Pregnancy, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
ControlOther
400 mcg of folic acid
| Study group | Role | What they receive |
|---|---|---|
| FertyBiotic Pregnancy | Experimental | Participants received FertyBiotic Pregnancy one capsule a day Receives: Dietary Supplement: FertyBiotic Pregnancy; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose homeostasis
Glucose homeostasis status will be evaluated by measuring fasting glucose
Measured: 30-32 weeks gestation
Secondary outcomes (4)
Insulin levels
Insulin levels status will be evaluated by measuring fasting insulin
Measured: 30-32 weeks gestation
Insulin resistance
Insulin resistance will be evaluated by measuring HOMA IR and QUICKI index (fasting glucose and fasting insulin combination)
Measured: 30-32 weeks gestation
Weight gain
Weight will be evaluated weighting the subjects
Measured: 30-32 weeks gestation
Lipid concentration
Lipid concentration will be evaluated by measuring fasting total colesterol, LDL, HDL and triglyceride
Measured: 30-32 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start5 May 2021
- Primary completion1 Nov 2025
- Study completion23 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertypharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935840
- Sponsor's protocol ID
- 2020_FBE_04
- Status last verified
- Nov 2025
- First submitted
- 7 Jun 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Effect of a Food Supplement With Probiotics on the Metabolic Profile of Pregnant Women
- ClinicalTrials.gov ID
- NCT04935840
- Acronym / sponsor ID
- 2020_FBE_04
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- FertypharmIndustry (pharma, biotech, devices)
- Study start
- 5 May 2021 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 23 Mar 2026 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FertyBiotic Pregnancy | Experimental | Dietary Supplement: FertyBiotic Pregnancy, Other: ControlParticipants received FertyBiotic Pregnancy one capsule a day |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FertyBiotic PregnancyDHA, folic acid, Iodine, iron, Lactobacillus rhamnosus, Lactobacillus reuterii, magnesium, zinc, vitamin D3, Vitamin C, Vitamin E, Group B vitamins and Biotin | Dietary supplement | FertyBiotic Pregnancy |
| Control400 mcg of folic acid | Other | FertyBiotic Pregnancy |
Primary outcome
Glucose homeostasis
Time frame: 30-32 weeks gestation
Glucose homeostasis status will be evaluated by measuring fasting glucose
4 secondary outcomes
Insulin levels
Time frame: 30-32 weeks gestation
Insulin resistance
Time frame: 30-32 weeks gestation
Weight gain
Time frame: 30-32 weeks gestation
Lipid concentration
Time frame: 30-32 weeks gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FertyBiotic Pregnancy in people with Pregnancy Related, run by Fertypharm at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose homeostasis (time frame: 30-32 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.