Clinical trial NCT04009889: Impact of Oral Probiotic Blend on Pregnancy Outcome
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: i-Health, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: N=162 pregnant women were randomly assigned to one of the 2 interventions: verum (Lactobacilli) or placebo
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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:

1. Subjects currently enrolled in another clinical study
2. Subjects having finished another clinical study within the last 4 weeks before inclusion
3. Diabetes mellitus
4. Acute metabolic disorder interfering with glucose metabolism
5. Known cancer \< 5y ago
6. Any ano-rectal infection, disease, surgery in the medical history or current which may have impact on microbiota
7. Anus praeter
8. Hypersensitivity, allergy or idiosyncratic reaction to any component of the test product
9. 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
10. History of active hepatitis B and C
11. History of HIV infection
12. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
13. Major cognitive or psychiatric disorders
14. Present drug abuse or alcoholism, reformed alcoholic Legal incapacity

Primary outcomes:
measure: HOMA-IR value in week 24-28
timeFrame: measurement between 24-28 week of pregnancy
measure: HOMA-IR value in week 36-40
timeFrame: measurement between 36-40 week of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Clinical Research Center Kiel GmbH
state: Schleswig-Holstein
Study officials:
affiliation: Clinical Research Center Kiel GmbH, Germany
name: Christiane Laue, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davidson SJ, Barrett HL, Price SA, Callaway LK, Dekker Nitert M. Probiotics for preventing gestational diabetes. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD009951. doi: 10.1002/14651858.CD009951.pub3.