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
capsule containing a probiotic blend of 5 different Lactobacilli
+ capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
Estudio de Prevención
Resumen
Fecha de inicio: 5 de abril de 2018
Fecha en la que se inscribió al primer participante.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
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 170 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
PlaceboObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Clinical Research Center Kiel GmbH
Kiel, GermanyAbrir Clinical Research Center Kiel GmbH en Google Maps