Prevention of Iron DeficiencyNCT02912416
Efficacy of Probiotics on Iron Status During Pregnancy
A study testing Probiotics in people with Prevention of Iron Deficiency, run by Probi AB at 1 site in Sweden.
Trial summary
Determine the effect of probiotics on improving iron status in a population of healthy, pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention of Iron Deficiency
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteSweden
- Study dates
- 9 Sep 2016to 11 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, pregnant women, aged 18-42 years, with a singleton gestation
- BMI ≥ 18 and ≤ 30 at baseline
- Provide signed and dated informed consent form
- Willing to comply with all study procedures
Who cannot join
- Serum ferritin level <20 µg/L or Hb<110 g/L at baseline (visit 1)
- Chronic diseases associated with anemia
- Known Thalassemia
- Hyperemesis gravidarum
- Chronic gastrointestinal disease (inflammable bowel diseases; Crohn's disease, Ulcerative Colitis; diarrheal disease)
- Known gluten intolerance, lactose intolerance, milk protein allergy
Show all 13Show fewer
- Taking antibiotics within four weeks before inclusion
- Blood or plasma donation within three (3) months prior to baseline
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- Smoking or use of nicotine-containing products (currently or during the last three [3] months)
- History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator
- Hypersensitivity to any of the ingredients in the study products
- Any other reason for exclusion, as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Determine the effect of probiotics on improving iron status in a population of healthy, pregnant women.
- Conditions
- Prevention of Iron Deficiency
- Being tested
- Probiotics, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Capsule with probiotics Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Capsule with placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin level
Measured: Week 28 of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start9 Sep 2016
- Primary completion11 Nov 2018
- Study completion11 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Iron DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912416
- Sponsor's protocol ID
- ProIron 16
- Status last verified
- Mar 2020
- First submitted
- 21 Sep 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotics on Iron Status During Pregnancy
- ClinicalTrials.gov ID
- NCT02912416
- Acronym / sponsor ID
- ProIron 16
- Conditions
- Prevention of Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 11 Nov 2018 (actual)
- Study completion
- 11 Nov 2018 (actual)
- First posted
- 23 Sep 2016 (estimated)
- 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.
Determine the effect of probiotics on improving iron status in a population of healthy, pregnant women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: ProbioticsCapsule with probiotics |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsule with placebo |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, pregnant women, aged 18-42 years, with a singleton gestation
- BMI ≥ 18 and ≤ 30 at baseline
- Provide signed and dated informed consent form
- Willing to comply with all study procedures
Key exclusion criteria (13 listed)
- Serum ferritin level <20 µg/L or Hb<110 g/L at baseline (visit 1)
- Chronic diseases associated with anemia
- Known Thalassemia
- Hyperemesis gravidarum
- Chronic gastrointestinal disease (inflammable bowel diseases; Crohn's disease, Ulcerative Colitis; diarrheal disease)
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 |
|---|---|---|
| Probiotics | Dietary supplement | Probiotics |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Serum ferritin level
Time frame: Week 28 of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Prevention of Iron Deficiency
Recruiting
Safety and Efficacy of Iron Prophylaxis With on Iron Homeostasis in Healthy Pregnant Women
Iron Deficiency Anemia in Pregnancy, Iron Deficiency in Pregnancy
RecruitingObservational study
Iron Supplementation and Anemia After Sleeve Gastrectomy
Iron Deficiency Anemia, Obesity
Enrolling by invitationPhase 1
Liposomal Iron Versus Ferrous Iron Supplementation for Early Prophylaxis of Iron Deficiency Anemia in Preterm Neonates
Iron Deficiency Anemia in Preterm Neaonates
Not yet recruitingPhase 4
Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After Cardiac Surgery
Anemia, Iron Deficiencies
RecruitingPhase 4
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
Myocardial Infarction, Acute
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Prevention of Iron Deficiency, run by Probi AB at 1 site in Sweden.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum ferritin level (time frame: Week 28 of 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 Mar 2020.