Trials / Completed
CompletedNCT03701893
Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis.
Evaluate the Effect of the Strain Lactobacillus PS11610 on the Microbiota of the Female and Male Genital Tract in Couples With Fertility Problems and Dysbiosis.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- ProbiSearch SL · Industry
- Sex
- All
- Age
- 20 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.
Detailed description
Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months. Four visits are included in the study period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Lactobacillus PS11610 | 7 months and a half intervention study. A 6 months intervention period preceded by a period of sampling and analysis of vaginal, seminal and gland swabs of 6 weeks. During the 6 months of intervention the men participants will intake one capsule that contains 1\*10E9 colony forming unit (CFU) of Lactobacillus PS11610 and the women participating will intake two capsules of the same product (each 12 hours). If the couple stay pregnant during the intervention the man will end the product intake and the woman will reduce the dose to one capsule with 1\*10E9 CFU of Lactobacillus PS11610 per day during 12 additional weeks. |
Timeline
- Start date
- 2018-10-22
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2018-10-10
- Last updated
- 2020-10-22
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03701893. Inclusion in this directory is not an endorsement.