Trials / Completed
CompletedNCT03701906
Effect of a Mixture of New Probiotic Strains in Preterm Infants
Effect of a Mixture of New Probiotic Strains in the Colonization of the Gastrointestinal Tract of Preterm Infants.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- ProbiSearch SL · Industry
- Sex
- All
- Age
- 1 Minute – 5 Days
- Healthy volunteers
- Accepted
Summary
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation. The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
Detailed description
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 \& Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation. The duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Lactobacillus PS11603 & Bifidobacterium PS10402 | Approximately 8 weeks intervention study: Participants with 0-5 days of age will start a period of 8 weeks of intervention. During this time the participants will intake one daily dose of the product that contains 1\*10E9 CFU of L.salivarius PS11603 and 1\*10E8 CFU of B.longum PS10402. |
| DIETARY_SUPPLEMENT | Placebo | 8 weeks intervention study: A 8 weeks intervention period. During the 8 weeks of intervention the participants will intake one daily dose of placebo supplement. |
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 NCT03701906. Inclusion in this directory is not an endorsement.