DysbiosisNCT04304014
Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery
A study testing L. reuteri and B. longum and P. Pentosaceus in people with Dysbiosis, run by Fundacion Clinic per a la Recerca Biomédica at 3 sites in Spain.
Trial summary
This study aims to determine the effect of three factors (delivery type, feeding type and the use of two different dietary supplements) on rebiosis after disbiotic delivery. This is a randomized, single-blinded study with two parallel arms. Group 1 will receive L. reuteri (10^8 CFU) once a day, group 2 will receive B. Read more about this study
- Who is it for?
- Ages Up to 25 days
- Conditions the study is for
- Dysbiosis
- What is being tested?
- L. reuteri and B. longum and P. Pentosaceus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesSpain
- Study dates
- 5 Mar 2020to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy infants up to 25 days of life
- Infants with adequate weight according to the gestational age.
- Infants born by vaginal delivery whose mother was given antimicrobial prophylaxis or infants born by C-section.
- Gestational birth equal or greater than 37 weeks.
- Exclusive or almost exclusive breastfeeding (understanding almost exclusive the one in which there is a maximum of one formula feeding per day) or mixed feeding (in which there is more than one formula feeding per day).
Who cannot join
- Infants with smoker mother during pregnancy and after delivery.
- Infants whose parents cannot follow the study requirements
- Infants who have suffered neonatal admission or have suffered or suffer necrotizing enterocolitis, infectious disease, congenital malformation, short bowel syndrome or any serious illness.
- Infants who have taken probiotics before the start of the trial or who take formula with probiotics.
- Breast-fed infants whose mothers have taken probiotics within the two weeks before study inclusion.
- Infants who ingest special formulas as extensively hydrolysed formulas.
Show all 9Show fewer
- Breast-fed infants whose mothers have excluded dairy products and egg products in their diet during breastfeeding
- Infants who take specific medication for the treatment of functional digestive disorders: antacids (type IBP or H2 blockers), laxatives (PEG, lactulose, magnesia), lactase and simethicone at the time of inclusion.
- Infants undergoing therapies with acupuncture, homeopathy, medicinal herbs, anti-inflammatories and antispasmodics at the time of inclusion.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Neonatal Unit, Hospital Clinic-Maternitat
Barcelona
Fundación HM Hospitales (Hospital HM Puerta Sur)
Madrid, Madrid, 28938
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
This study aims to determine the effect of three factors (delivery type, feeding type and the use of two different dietary supplements) on rebiosis after disbiotic delivery. This is a randomized, single-blinded study with two parallel arms. Group 1 will receive L. reuteri (10^8 CFU) once a day, group 2 will receive B. longum and P. Pentosaceus (10^9 CFU) once a day. The total duration of intervention will be 3 months.
Read the detailed description
Gut colonization during the first days of life represents the start of the infant's own microbiota. This process is influenced by different factors: delivery type, feeding type, antibiotic treatment, etc. On the one hand, vaginally delivered babies are in contact with mother's vaginal and faecal microbiota. This fact will drive a neonatal gut colonization composed of vagina-associated bacteria. In contrast, babies born by C-section are more susceptible to be colonized by microorganisms present in the mother's skin. On the other hand, antibiotic administration during vaginal delivery also produces alterations in the vaginal microbiota of the mother. Described scenarios have been correlated to immunological and metabolic diseases such as asthma, allergies, diabetes or obesity. Moreover, disbiosis has also been associated to functional gastrointestinal disorders (FGID) in babies such as infant colic and functional constipation. After a disbiotic delivery, medical doctors usually recommend the use of probiotics to prevent rebiosis. Since the probiotics.
- reuteri, and B. longum and P. Pentosaceus have shown efficacy on FGID amelioration in previously published articles, these two probiotics were selected for the present study. All together, this study aims to characterize the role of three different parameters: type of probiotic, delivery type and feeding type.
- Conditions
- Dysbiosis
- Being tested
- L. reuteri, B. longum and P. Pentosaceus
- Keywords
- probiotic, microbiota, newborn
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteriDietary supplement
(10^8 CFU) once a day for 3 months
B. longum and P. PentosaceusDietary supplement
(10^9 CFU) once a day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri | Experimental | Group that will receive L. reuteri one dose per day in an oral suspension
Intervention: Dietary Supplement: L. reuteri Receives: Dietary Supplement: L. reuteri |
| B. longum and P. Pentosaceus | Experimental | Group that will receive B. longum and P. Pentosaceus one dose per day in an oral suspension. Intervention: Dietary Supplement: B. longum and P. Pentosaceus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of bifidobacteria
Changes in the relative abundance of bifidobacteria in stool microbiota after 1 month of supplementation, measured with metagenomic techniques.
Measured: 1 month
Secondary outcomes (10)
Number of regurgitations by questionnaire included in patients' diary
Number of regurgitations will be documented by the parents each week for 3 months in patients diary
Measured: 3 months
Number of constipation episodes by questionnaire included in patients' diary
Number of constipation episodes will be documented by the parents each week for 3 months in patients' diary
Measured: 3 months
Number of infant colic episodes by questionnaire included in patients' diary
Number of constipation episodes will be documented by the parents each week for 3 months in patient's diary
Measured: 3 months
Metagenomic analysis of total gut microbiota
This measure includes all bacteria detected in feaces by metagenomic analysis. Faecal samples will be collected at baseline and 1 month after probiotic treatment. Analysis will comprise changes in the relative abundance of B. longum and P. Pentosaceous as well as in other bacterial groups common in the infant gut. In addition, the proportion (Bifidobacterium + Lactobacillus + Bacteroides) will be determined
Measured: 1 month
Respiratory, gastrointestinal infections and use of medication by questionnaire included in patients' diary
Number of respiratory, gastrointestinal infections and use of medication episodes will be documented by the parents each week for 3 months in patient's diary
Measured: 3 months
Anxiety and depression by the validated Hospital Anxiety and Depression scale (HADS)
Anxiety and depression levels of the father and mother will be evaluated at baseline and 3 months after probiotic treatment through the Hospital Anxiety and Depression Scale (HADS) questionnaire will be.
Odd questions (assess anxiety). Even questions (assess depression). Score less than or equal to 7 = no case. 8-10 = doubtful case Score equal to or greater than 11 = case
Measured: 3 months
Extra visits to paediatrician/emergency by questionnaire included in the patient's diary
Number of paediatric visits and / or emergency access will be documented each week in the patient's diary during the 3 months of treatment
Measured: 3 months
Number of Participants With Treatment-Related Adverse Events
Adverse events will be documented weekly in the patient's diary during the 3 months of treatment.
Measured: 3 months
Levels of IgA in faeces
changes in IgA in faeces from baseline to 1 month of treatment
Measured: 1 month
Weight evolution by the paedatrician in study visits
Changes on baby's body weight from baseline to 3 months of probiotic treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start5 Mar 2020
- Primary completion12 Mar 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Óscar García-Algar, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304014
- Sponsor's protocol ID
- Pro-Care 3
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery
- ClinicalTrials.gov ID
- NCT04304014
- Acronym / sponsor ID
- Pro-Care 3
- Conditions
- Dysbiosis
- Keywords
- probiotic, microbiota, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effect of three factors (delivery type, feeding type and the use of two different dietary supplements) on rebiosis after disbiotic delivery. This is a randomized, single-blinded study with two parallel arms. Group 1 will receive L. reuteri (10^8 CFU) once a day, group 2 will receive B. longum and P. Pentosaceus (10^9 CFU) once a day. The total duration of intervention will be 3 months.
Detailed description
Gut colonization during the first days of life represents the start of the infant's own microbiota. This process is influenced by different factors: delivery type, feeding type, antibiotic treatment, etc. On the one hand, vaginally delivered babies are in contact with mother's vaginal and faecal microbiota. This fact will drive a neonatal gut colonization composed of vagina-associated bacteria. In contrast, babies born by C-section are more susceptible to be colonized by microorganisms present in the mother's skin. On the other hand, antibiotic administration during vaginal delivery also produces alterations in the vaginal microbiota of the mother. Described scenarios have been correlated to immunological and metabolic diseases such as asthma, allergies, diabetes or obesity. Moreover, disbiosis has also been associated to functional gastrointestinal disorders (FGID) in babies such as infant colic and functional constipation. After a disbiotic delivery, medical doctors usually recommend the use of probiotics to prevent rebiosis. Since the probiotics.
- reuteri, and B. longum and P. Pentosaceus have shown efficacy on FGID amelioration in previously published articles, these two probiotics were selected for the present study. All together, this study aims to characterize the role of three different parameters: type of probiotic, delivery type and feeding type.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri | Experimental | Dietary Supplement: L. reuteriGroup that will receive L. reuteri one dose per day in an oral suspension Intervention: Dietary Supplement: L. reuteri |
| B. longum and P. Pentosaceus | Experimental | –Group that will receive B. longum and P. Pentosaceus one dose per day in an oral suspension. Intervention: Dietary Supplement: B. longum and P. Pentosaceus |
Who may qualify
- Ages
- Up to 25 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy infants up to 25 days of life
- Infants with adequate weight according to the gestational age.
- Infants born by vaginal delivery whose mother was given antimicrobial prophylaxis or infants born by C-section.
- Gestational birth equal or greater than 37 weeks.
- Exclusive or almost exclusive breastfeeding (understanding almost exclusive the one in which there is a maximum of one formula feeding per day) or mixed feeding (in which there is more than one formula feeding per day).
Key exclusion criteria (9 listed)
- Infants with smoker mother during pregnancy and after delivery.
- Infants whose parents cannot follow the study requirements
- Infants who have suffered neonatal admission or have suffered or suffer necrotizing enterocolitis, infectious disease, congenital malformation, short bowel syndrome or any serious illness.
- Infants who have taken probiotics before the start of the trial or who take formula with probiotics.
- Breast-fed infants whose mothers have taken probiotics within the two weeks before study inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L. reuteri(10^8 CFU) once a day for 3 months | Dietary supplement | L. reuteri |
| B. longum and P. Pentosaceus(10^9 CFU) once a day for 3 months | Dietary supplement | – |
Primary outcome
Relative abundance of bifidobacteria
Time frame: 1 month
Changes in the relative abundance of bifidobacteria in stool microbiota after 1 month of supplementation, measured with metagenomic techniques.
10 secondary outcomes
Number of regurgitations by questionnaire included in patients' diary
Time frame: 3 months
Number of constipation episodes by questionnaire included in patients' diary
Time frame: 3 months
Number of infant colic episodes by questionnaire included in patients' diary
Time frame: 3 months
Metagenomic analysis of total gut microbiota
Time frame: 1 month
Respiratory, gastrointestinal infections and use of medication by questionnaire included in patients' diary
Time frame: 3 months
Anxiety and depression by the validated Hospital Anxiety and Depression scale (HADS)
Time frame: 3 months
Extra visits to paediatrician/emergency by questionnaire included in the patient's diary
Time frame: 3 months
Number of Participants With Treatment-Related Adverse Events
Time frame: 3 months
Levels of IgA in faeces
Time frame: 1 month
Weight evolution by the paedatrician in study visits
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. reuteri and B. longum and P. Pentosaceus in people with Dysbiosis, run by Fundacion Clinic per a la Recerca Biomédica at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of bifidobacteria (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.