The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants

NCT03310853 | Completed Phase 2

• 1 other identifier: MOM study
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

probiotics; infections; bacterial vaginosis

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 weeks

Secondary Outcomes (24)

• Levels of glucose, insulin, triglycerides and iron

  Measured 2 times up to 12 weeks

• Vaginal mycobiota

  Measured 3 times up to 18 weeks

• Inflammatory markers

  Measured up to 3 times in the 18 week time frame

• Vaginal microbiota

  Measured 3 times up to 18 weeks

• Premature rupture of membranes (PROM)

  Measured 1 time at week 12

Study Arms (2)

Probiotic

EXPERIMENTAL

Combination of two probiotic strains in one capsule

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Non active ingredients in a capsule

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Dosing regimen of one capsule daily for a maximum of 18 weeks

Probiotic

Placebo OTHER

Dosing regimen of one capsule daily for a maximum of 18 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women
• Less than 28 weeks of gestation (3rd trimester)
• ≥18 to \<40 years old
• Singleton gestation
• Availability and willingness to come in for morning visits
• Planning to breastfeed
• Willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits
• Willing to discontinue consumption of fermented foods (e.g. foods that contain probiotics such as Kefir, pickles, etc.) or probiotics (e.g. yogurts with live active cultures or probiotic supplements)
• Able to provide informed consent

You may not qualify if:

• Known gestational diabetes or diabetes type 1 or 2
• Known blood/bleeding disorders
• Known liver and kidney disorders
• Known unstable cardiovascular diseases
• Women with a personal history of or currently diagnosed with preeclampsia
• Suffering from neurological diseases (e.g. Alzheimer's disease, Parkinson's disease, epilepsy, etc.)
• Suffering from gastrointestinal diseases (e.g. gastric ulcers, Crohn's disease, ulcerative colitis, etc.)
• Current symptoms of depression or experienced depressive symptoms in the past 2 years
• Maternal history of second trimester loss
• Women diagnosed HIV Positive or with Hepatitis B or C
• Known fetal abnormality
• Daily use of probiotic product within 2 weeks of the screening visit. The potential participant could be eligible to participate after a 2-week wash-out period
• Use of any antibiotic drug within 1 month of screening. The potential participant could be eligible to participate after a 2-week wash-out period
• Smoking, alcohol consumption or drug use during pregnancy
• History of alcohol or substance abuse six months prior to screening

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• Clinique Ovo: collaborator

Study Sites (1)

Clinique OVO

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Infections; Vaginosis, Bacterial

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jacques Kadoch, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 16, 2017
• Study Start: October 23, 2017
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)