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| Name | Class |
|---|---|
| Hospital San Carlos, Madrid | OTHER |
| Universidad Complutense de Madrid | OTHER |
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The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | All women in the probiotic group consume (oral route) a daily capsule with ~50 mg of freeze-dried probiotic (9.5 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin) during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation. |
|
| Placebo group | Placebo Comparator | All women in the placebo group consume (oral route) a daily capsule with ~50 mg of maltodextrin during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligilactobacillus salivarius CECT5713 | Dietary Supplement | Oral administration of a capsule containing 9.5 log10 cfu of the strain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful pregnancies | Total number of pregnancies with delivery of a healthy baby | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modification of the vaginal microbiota | Variation in the concentration of lactobacilli and other microbes in vaginal samples (Staph ylococcus, Streptococcus, Enterococcus, Corynebacterium, Rothia, Arthrobacter, Acinetobacter, Actinomyces) | 9 months |
| Vaginal immunomodulation |
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Inclusion Criteria:
Exclusion Criteria:
The target is infertility of unknown origin. The outcome is a successful pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Juan M. Rodríguez, PhD | Complutense University Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biosearch S.A.U. | Granada | 18004 | Spain | |||
| Hospital Clínico San Carlos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33419054 | Background | Fernandez L, Castro I, Arroyo R, Alba C, Beltran D, Rodriguez JM. Application of Ligilactobacillus salivarius CECT5713 to Achieve Term Pregnancies in Women with Repetitive Abortion or Infertility of Unknown Origin by Microbiological and Immunological Modulation of the Vaginal Ecosystem. Nutrients. 2021 Jan 6;13(1):162. doi: 10.3390/nu13010162. |
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Global and individual reproductive rates, microbiological and immunological data will be available to other researchers once the study (including analyses of all the samples) is completed and published.
All the raw data will be available to other researchers once the study is published.
Our intention is that all the raw data will be available as a supplementary tables in an open acess journal. They will be also provided on request.
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Parallel Assignment Volunteers are classified into 2 groups. All women in the probiotic group consume (oral route) a daily capsule with ~50 mg of freeze-dried probiotic (9.5 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin). All women in the placebo group consume (oral route) a daily capsule with ~50 mg of maltodextrin.
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Triple (Participant, Care Provider, Investigator) Only one person of the collaborator that provides the capsules (Biosearch Life) know the correspondecs between each reference (one reference per each subject) and the arm (probiotic or placebo). The codes are blinded for the participant, the care provider and the investigator.
| Placebo | Dietary Supplement | Oral administration of a capsule containing maltodextrin. |
|
Variation in the concentration of immune factors in vaginal samples. The presence and concentration of a wide spectrum of cytokines, chemokines and growth factors (IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, RANTES, TGF-β1, 2 and 3, VEGF, GRO-alpha and TNF-alpha) |
| 9 months |
| Madrid |
| 28040 |
| Spain |
| Universidad Complutense de Madrid | Madrid | 28040 | Spain |