NCT02912416

Brief Summary

Determine the effect of probiotics on improving iron status in a population of healthy, pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 9, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2018

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

September 21, 2016

Last Update Submit

March 3, 2020

Conditions

Prevention of Iron Deficiency

Outcome Measures

Primary Outcomes (1)

  • Serum ferritin level

    Week 28 of gestation

Study Arms (2)

Probiotics

EXPERIMENTAL

Capsule with probiotics

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Capsule with placebo

Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT
Probiotics
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CuraÖresund

Malmo, 205 12, Sweden

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 23, 2016

Study Start

September 9, 2016

Primary Completion

November 11, 2018

Study Completion

November 11, 2018

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)