Back to resultsModulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713
Primary Purpose
Abortion, Spontaneous, Abortion in First Trimester, Infertility Unexplained
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ligilactobacillus salivarius CECT5713
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Abortion, Spontaneous focused on measuring Abortion, Infertility
Eligibility Criteria
Inclusion Criteria: legal age Intention to achieve a pregnancy, but without achieving it; Be willing to undergo in vitro fertilization treatment; Be on the waiting list for the IVF cycle with an expected waiting time > 5 months. Exclusion Criteria: Sterility in one of the members of the couple (azoospermia; impermeability of the fallopian tubes...). Genitourinary malformations; Concurrence of other severe diseases (e.g.: cancer, AIDS, ALS, morbid obesity...) or uncontrolled diseases (inflammatory bowel diseases, diabetes...). Treatment/intervention other than the planned IVF after the start date of the intervention. Antibiotic treatment at the start date of the intervention. Intention to consume another probiotic supplement in the following 3 months. Participation in another clinical trial. Allergic/intolerant to the excipient. Inability to understand the informed consent form and/or to follow the basic instructions of the trial.
Sites / Locations
- Dpt. Nutrición y Ciencia de los Alimentos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic group
Placebo group
Arm Description
All women in the probiotic group consume (oral route) a daily capsule with ~50 mg of freeze-dried probiotic (~9 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.
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.
Outcomes
Primary Outcome Measures
Successful pregnancies
Total number of pregnancies with delivery of a healthy baby
Secondary Outcome Measures
Modification of the vaginal microbiota
Variation in the concentration of lactobacilli and other microbes in vaginal samples
Vaginal immunomodulation
Variation in the concentration of immune factors in vaginal samples
Full Information
NCT ID
NCT05896657
First Posted
May 31, 2023
Last Updated
May 31, 2023
Sponsor
Universidad Complutense de Madrid
Collaborators
Hospital San Carlos, Madrid, Biosearch S.A.
1. Study Identification
Unique Protocol Identification Number
NCT05896657
Brief Title
Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713
Official Title
Modulation of the Reproductive Microbiota as a Strategy to Increase Rates of Reproductive Success in Couples With Infertility of Unknown Origin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 3, 2023 (Actual)
Study Completion Date
December 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Hospital San Carlos, Madrid, Biosearch S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Spontaneous, Abortion in First Trimester, Infertility Unexplained
Keywords
Abortion, Infertility
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
All women in the probiotic group consume (oral route) a daily capsule with ~50 mg of freeze-dried probiotic (~9 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ligilactobacillus salivarius CECT5713
Intervention Description
Oral administration of a capsule containing 9 log10 cfu of the strain.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Oral administration of a capsule containing maltodextrin.
Primary Outcome Measure Information:
Title
Successful pregnancies
Description
Total number of pregnancies with delivery of a healthy baby
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Modification of the vaginal microbiota
Description
Variation in the concentration of lactobacilli and other microbes in vaginal samples
Time Frame
9 months
Title
Vaginal immunomodulation
Description
Variation in the concentration of immune factors in vaginal samples
Time Frame
9 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The targets are repetitive abortion or infertility of unknown origin. The outcome is a successful pregnancy.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
legal age
Intention to achieve a pregnancy, but without achieving it;
Be willing to undergo in vitro fertilization treatment;
Be on the waiting list for the IVF cycle with an expected waiting time > 5 months.
Exclusion Criteria:
Sterility in one of the members of the couple (azoospermia; impermeability of the fallopian tubes...).
Genitourinary malformations;
Concurrence of other severe diseases (e.g.: cancer, AIDS, ALS, morbid obesity...) or uncontrolled diseases (inflammatory bowel diseases, diabetes...).
Treatment/intervention other than the planned IVF after the start date of the intervention.
Antibiotic treatment at the start date of the intervention.
Intention to consume another probiotic supplement in the following 3 months.
Participation in another clinical trial.
Allergic/intolerant to the excipient.
Inability to understand the informed consent form and/or to follow the basic instructions of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan M Rodriguez, PhD
Organizational Affiliation
Complutense University Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt. Nutrición y Ciencia de los Alimentos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
All the raw data will be available to other researchers once the study is published.
IPD Sharing Access Criteria
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.
Citations:
PubMed Identifier
33419054
Citation
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.
Results Reference
background
Learn more about this trial
Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713
We'll reach out to this number within 24 hrs