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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
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The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is:
Do maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants.
Participants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.
The gut microbiota has long-term effects on host health especially in early life. Infants receive maternal faecal microbes during vaginal birth, which is prevented by C-section. C-section is associated with increased risk of many chronic diseases, likely because of the disturbed gut microbiota. We recently showed the effectiveness of a faecal microbiota transplant from the infant's own mother in restoring normal gut microbiota in C-section born infants. However, FMT contains a large diversity of unknown microbes, some of which may pose a risk of dangerous infection. A safe and widely applicable infant microbiota restoration method is urgently needed. In this project, we develop a selective microbiota transplant from mother to infant and test its efficacy and safety in a clinical trial. The work is conducted in the Faculty of Medicine, University of Helsinki.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | The infants will receive a mixture of probiotic strains currently on the market and with known safety profiles and beneficial effects on infant gut microbiota. |
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| Vaginal delivery | No Intervention | ||
| Maternal bacteria set 1 | Experimental | The infants will receive a micture of bacteria isolated from a fecal sample of the infants' own mother. |
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| Maternal bacteria set 2 | Experimental | The infants will receive a mixture of bacterial species with increased diversity isolated from the mother's sample. |
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| Maternal bacteria set 3 | Other | The infants will receive a mixture of bacterial strains isolated from other infants' and/or mothers' samples to test whether bacteria from an unrelated donor have different effects compared to maternal bacteria. In this group all infants will receive the same standardised mixture of bacterial strains. |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Specific infant-adapted commercially available strains or strains isolated from the infant's mother. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota composition, relative and absolute abundances | Similarity of the overall gut, mouth, and skin microbiota composition | 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks. |
| Fecal metabolite profiles | Fecal metabolite profiles in the treatment groups compared to the vaginally born reference group. | 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katri E Korpela, PhD | Contact | +358504486369 | katri.korpela@helsinki.fi | |
| Marjo Metsäranta, MD, PhD | Contact | marjo.metsaranta@hus.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | Finland |
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| Placebo Comparator |
C-section born infants given a placebo treatment. |
|
| Placebo | Other | Infant formula without bacteria. |
|
| University of Helsinki | Recruiting | Helsinki | Finland |
|
| ID | Term |
|---|---|
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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