A Phase 2 interventional study of Probiotic and Placebo in Pregnancy, sponsored by Lallemand Health Solutions. Completed at 1 site in Canada. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by Lallemand Health Solutions · Phase 2, Interventional, and Supportive care
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
This phase 2 study evaluates the effect of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a health pregnancy. In addition, the effect of probiotics intake during pregnancy and breastfeeding on the infant's overall health status will be evaluated.
Throughout pregnancy women undergo many biological changes, including alterations in their microbiota. These infections can exacerbate pregnancy complications and increase the risk of preeclampsia and preterm birth. The present study aims to evaluate the potential effects of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a healthy pregnancy. Potential infections include but are not limited to influenza/colds, bacterial vaginosis, mastitis, candidiasis, urinary tract infection and gingivitis. Additionally, the benefits of probiotic intake by the mother on the infant during pregnancy and breastfeeding will be evaluated.
2,094 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's enrollment of 180 is above the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →Lallemand Health Solutions is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination of two probiotic strains in one capsule
Dietary Supplement: Probiotic
Non active ingredients in a capsule
Other: Placebo
Dosing regimen of one capsule daily for a maximum of 18 weeks
Dosing regimen of one capsule daily for a maximum of 18 weeks
Number of diagnosed infections in pregnant women
This includes any viral, bacterial and fungal infection (e.g. bacterial vaginosis, candidiasis, urinary tract infection, mastitis, cold, flu, gingivitis, etc.). A vaginal swab and saliva sample will be taken at every visit on site throughout pregnancy. The vaginal swab will be used for the detection of Bacterial Vaginosis and Candidiasis. Other required swab samples will be collected if an infection occurs (e.g. vaginal, mouth, throat, nose, etc.). If an infection is suspected by a participant in-between a scheduled visit, the participant will come on site to be checked by a doctor. If the participant is subsequently diagnosed with an infection, a saliva sample will need to be taken at this time.
Time frame: up to 12 weeks
Levels of glucose, insulin, triglycerides and iron
Assessed via blood sample throughout the pregnancy
Time frame: Measured 2 times up to 12 weeks
Vaginal mycobiota
Vaginal microbiome which includes bacteria, fungus and potentially other eukaryotic micro-organisms such as parasites or viruses. To be assessed with a vaginal swab during pregnancy and after delivery.
Time frame: Measured 3 times up to 18 weeks
Inflammatory markers
Assessing levels of both pro- and anti- inflammatory markers in the mother during pregnancy (through stool and blood samples) and after delivery (through breast milk sample).
Time frame: Measured up to 3 times in the 18 week time frame
Vaginal microbiota
Effects of the probiotic interventions on overall microbiota composition in the mother will be assessed. In addition, recovery of the probiotic strains in the vaginal samples will be assessed.
Time frame: Measured 3 times up to 18 weeks
Premature rupture of membranes (PROM)
Incidence of PROM on the probiotic versus the group
Time frame: Measured 1 time at week 12
Levels of secretory immunoglobulin A (sIgA) in the mother
Assessed via saliva samples throughout pregnancy and a breast milk sample after delivery.
Time frame: Measured up to 4 times in the 18 week time frame
Levels of secretory immunoglobulin A (sIgA) in the infant
Assessed via stool sample after birth.
Time frame: Measured 1 time up to18 weeks
Gut microbiota in the mother
Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed.
Time frame: Measured 3 times up to 18 weeks
Gut microbiota in the infant
Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed.
Time frame: Measured 1 time up to 18 weeks
Stool frequency and consistency in the mother
Assessed with the Bristol Stool Scale
Time frame: Self-reported, daily up to 18 weeks
Stool frequency and pattern in the infant
Assessed with the Amsterdam Infant Stool Scale
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Weight in the mother
To assess change in body weight
Time frame: Measured 3 times up to 18 weeks. Pre-pregnancy weight will also be noted via information collection on a demographic questionnaire.
Breast milk microbiota
Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the breast milk samples will be assessed.
Time frame: Measured 1 time up to 18 weeks
Post-Partum Depression
To be assessed with the Edinburgh Postnatal Depression Scale
Time frame: Measured 2 time up to 18 weeks
Infant's health status - NEC
To assess the probability of an infant with NEC
Time frame: Measured 1 time up to 18 weeks.
Anthropometric measurements
Crown-heel length and head circumference
Time frame: Measured 1 time up to 18 weeks. The infant's anthropometric measurements at birth will also be noted.
Weight in the infant
To assess change in body weight
Time frame: Measured 2 times up to 18 weeks.
Crying time in the infant
To assess the mean daily crying time of infants
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Colic in the infant
To asses the probability of an infant with colic
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Sleep in the infant
Number of total hours and number of consecutive hours
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Number of infections
To assess the number of infections
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Skin diseases or conditions
Skin diseases/conditions as well as the child's overall health status 1 year after birth will be assessed.
Time frame: 1 year follow up phone call
Infant's health status - jaundice
To assess the probability of an infant with jaundice
Time frame: Measured 1 time up to 18 weeks.
Infant's health status - Hyperbilirubinemia
To assess the probability of an infant with Hyperbilirubinemia
Time frame: Measured 1 time up to 18 weeks.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in May 2022, 54 months.
Of 42 industry-sponsored phase 2 interventional studies under Infections, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 18. This study's 54 months is above that.
Counting every sponsor, half of 77 studies reached it within 16 months; a quarter within 10 and three quarters within 47.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Probiotic
Lallemand Health Solutions