Skip to main content
OpenTrials
Completed

NCT Number: NCT04009889

Impact of Oral Probiotic Blend on Pregnancy Outcome

The aim of this study is, to investigate the effect of oral intake of Lactobacillus rhamnosus GG (ATCC 53103), Lactobacillus crispatus Lbv88, Lactobacillus rhamnosus Lbv96, Lactobacillus jensenii Lbv116 Lactobacillus gasseri Lbv150 on outcomes of pregnancy and microbiota and their interrelation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center Kiel GmbH

Kiel, Schleswig-Holstein, D-24118, Germany

About this study

Pregnant women aged > 18 years in the < 14th week of pregnancy willing to consume the study product once daily starting the day after V1 until delivery, complying with inclusion and exclusion criteria will be enrolled in the study.

After enrollement subjects will be randomly and evenly assigned to one of the two test groups verum and placebo.

The study population will be recruited in a screening examination ( G1 ) by gynaecologists from Kiel area.

Primary target parameter of the study :

HOMA-IRa value in week 24-28 (V2), which is based on glucose and insulin measures during the second oral glucose tolerance test (OGTT)

Secondary target parameters :

HOMA-IR value in week 36-40 , Alteration (V2 - V1) Δ HOMA-IR, Alteration (V2 - V1) Δ QUICKI

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women aged > 18 years in the < 14 week of pregnancy
  • willing to consume the study product during pregnancy ( V1 to delivery)
  • willingness to abstain from probiotic food and supplements containing probiotics
  • written informed consent

Exclusion criteria

Any of the following is regarded as a criterion for exclusion from enrollment in the study:

  • Subjects currently enrolled in another clinical study
  • Subjects having finished another clinical study within the last 4 weeks before inclusion
  • Diabetes mellitus
  • Acute metabolic disorder interfering with glucose metabolism
  • Known cancer < 5y ago
  • Any ano-rectal infection, disease, surgery in the medical history or current which may have impact on microbiota
  • Anus praeter
  • Hypersensitivity, allergy or idiosyncratic reaction to any component of the test product
  • Any disease or condition which might significantly compromise the hematopoietic, renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular, immunological, central nervous, dermatological or any other body system
  • History of active hepatitis B and C
  • History of HIV infection
  • Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
  • Major cognitive or psychiatric disorders
  • Present drug abuse or alcoholism, reformed alcoholic Legal incapacity

Treatment and study plan

capsule containing a probiotic blend of 5 different Lactobacilli

Dietary Supplement

n=81 women (verum) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.

Other names: verum

capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.

Other

n=81 women (placebo) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.

Other names: placebo

Primary outcomes

  1. HOMA-IR value in week 24-28

    Time frame: measurement between 24-28 week of pregnancy

    HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance

  2. HOMA-IR value in week 36-40

    Time frame: measurement between 36-40 week of pregnancy

    HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance

Sponsors and collaborators

Lead sponsor

i-Health, Inc.

Industry

Registry information

Official study title

Double Blind,Randomized, Controlled Trial on Impact of Oral Probiotic Blend ( Lactobacillus Rhamnosus GG, L. Crispatus LBV88, L. Rhamnosus LBV96, L.Jensenii LBV116 and L. Gasseri LBV150 ) on Pregnancy Outcome

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.